362 registered reports

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  • How leaders’ multiple identity prototypicality is related to their perceived effectiveness

    Niklas Steffens, Kim Peters, S. Haslam, Michael Platow·2017
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  • The value of money: On how childhood economic resources influence value assessments later in life.

    Gró Einarsdóttir, André Hansla, Lars-Olof Johansson·2017
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  • Status, Power, and Moral Licensing

    Alexander Danvers·2020
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  • Differences in Prosocial Behavior Regarding Decisions About how to Allocate Money and Time are due to Decision-Makers’ Characteristics

    PsychArchives is a disciplinary repository for psychological science and neighboring disciplines.

    Johannes Leder, Alexander Pastukhov, Astrid Schütz·2019
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  • Ideological Differences (AIID)

    Kubin & Brandt's project examining ideological differences and similarities using the AIID data.

    Emily Kubin, Mark Brandt·2019
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  • Effectiveness of an mHealth Intervention Combining a Smartphone App and Smart Band on Body Composition in an Overweight and Obese Population: Randomized Controlled Trial (EVIDENT 3 Study)

    Cristina Lugones-Sanchez, Maria Antonia Sanchez-Calvaera, Irene Repiso-Gento, Esther G Adalia, J Ignacio Ramirez-Manent, Cristina Agudo-Conde, Emiliano Rodriguez-Sanchez, Manuel Angel Gomez-Marcos, Jose I Recio-Rodriguez, Luis Garcia-Ortiz·2020·JMIR mHealth and uHealth
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  • Unethical Behaviour in the Workplace:A Direct and Conceptual Replication of Jon7es & Kavanagh (1996)

    Thomas Evans, James Bartlett·2022
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  • Comparing data-driven subtypes of depression informed by clinical and neuroimaging data: A Registered Report

    Background: Efforts to elucidate subtypes within depression have yet to establish a consensus. This study aims to rigorously compare different subtyping approaches in the same subject space, to quantitatively test agreement across subtyping approaches and determine if the different approaches are sensitive to different sources of heterogeneity in depression. Methods: We will implement six different data-driven subtyping methods developed in prior work using the same UK Biobank participants (N=3,724 depressed cases and N=2,631 healthy controls). The six approaches include two symptom-based, two structural neuroimaging-based and two functional neuroimaging-based techniques. The resulting subtypes will be compared based on subject assignment, stability, and sensitivity to subgroup differences in categories of demographics, general health, clinical characteristics, neuroimaging, trauma, cognitive, genetics, inflammation markers. Proposed Analyses: We will assess the subject agreement of the subtype solutions using Adjusted Rand Index, the stability of the subtype solutions using bootstrapping, and evaluate domain (clinical, biological, neuroimaging) sensitivity differences between subtype approaches by performing general linear models on phenotypes unseen by previous analysis comparing subtypes within each approach and determining statistical difference in variance explained across subtype approaches (using permutation testing).

    Kayla Hannon, Luca Balogh, Fyzeen Ahmad, Petra Lenzini, Aristeidis Sotiras, Janine Bijsterbosch·2023
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  • Does Ego Depletion Reduce Judgment Adjustment for Both Internally and Externally Generated Anchors?

    Lukas Röseler, Astrid Schütz, Ulrike Starker, Roy Baumeister·2019
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  • How does stock liquidity affect corporate cash holdings in Japan?: A pre-registered report

    This pre-registered report outlines a comprehensive plan for a paper aimed at examining the positive relationship between stock liquidity and corporate cash holdings within the context of Japan. This study aims to offer a novel explanation. Our explanation is rooted in the “dark side” of stock liquidity, suggesting that liquidity could exacerbate corporate financial constraints by increasing the stock price crash risk. If managers expect liquidity to cause the surge of the cost of external capital, they will have a precautionary motive to retain cash. We plan to examine whether stock liquidity positively affects corporate cash holdings in Japan. Furthermore, we plan to isolate our hypothesis from other possible explanations by assessing whether the positive liquidity-cash relationship is more pronounced in firms experiencing overvaluation.

    Ryosuke Fujitani, Kiyonori Iwata, Yukihiro Yasuda·2024·Pacific-Basin Finance Journal
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  • Autistic and non-autistic prosocial decision-making: The impact of recipient neurotype

    A body of research suggests cross-neurotype interpersonal interactions may be more challenging, and non-autistic individuals show less interest in interactions with their autistic peers. However, it is not clear whether such cross-neurotype differences extend to prosocial decision-making behaviour – something that is vital for forming and maintaining social bonds. In this Registered Report Protocol (given Stage 1 in principle acceptance from Research in Autism Spectrum Disorder) and using a well-established physical-effort-based decision-making paradigm, in combination with computational modelling, we examine autistic and non-autistic prosocial willingness to exert physical effort for oneself and others, as a function of whether they know the beneficiary of those actions to be of the same or cross-neurotype. We collect data from 60 individuals; 30 with and 30 without a clinical diagnosis of autism and compare decisions to exert effort as well as subsequent effort put into those actions when participants are making decisions for the self, other same-neurotype and other different-neurotype. Finally, we explore whether prosocial effort differences can be explained by biases (explicitly or implicitly) held about autism. This work has implications for understanding how interactor neurotypes and autism-specific biases may feed into prosocial decision-making contexts such as employment, health and education settings, where autistic individuals face the everyday consideration whether to disclose their diagnostic status.

    Sophie Sowden-Carvalho, Selma Lugtmeijer, Connor Keating, Peter Rush·2025
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  • WalkIT: Neighborhood Walkability and Moderation of Adaptive Walking Interventions

    The purpose of this study is to develop adaptive (AI) and micro-incentive (MI) interventions and test them against static (SI) and delayed-incentive (DI) interventions in a 4-arm randomized factorial trial to increase MVPA adoption and maintenance among inactive adults. Using neighborhood walkability and socioeconomic status, participants will be recruited from four neighborhood types: "high walkable/high SES," "high walkable/low SES," "low walkable/high SES," and "low walkable/low SES." We will evaluate synergistic or antagonistic effects of interventions and neighborhood factors on MVPA adoption by 12 months and maintenance by 24 months.

    Marc Adams, Arizona State University, National Cancer Institute (NCI)·2021
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  • DIETFITS study (diet intervention examining the factors interacting with treatment success) – Study design and methods

    Michael V. Stanton, Jennifer L. Robinson, Susan M. Kirkpatrick, Sarah Farzinkhou, Erin C. Avery, Joseph Rigdon, Lisa C. Offringa, John F. Trepanowski, Michelle E. Hauser, Jennifer C. Hartle, Rise J. Cherin, Abby C. King, John P.A. Ioannidis, Manisha Desai, Christopher D. Gardner·2017·Contemporary Clinical Trials
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  • A Perspective on the Role of Human Behaviors in Software Development: Voice and Silence*

    Mary Sánchez-Gordón, Ricardo Colomo-Palacios, Muhammad Azeem Akbar, Monica Kristiansen Holone·
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  • An unsupervised online Tai Chi program for people with knee osteoarthritis (“My Joint Tai Chi”): Study protocol for the RETREAT randomised controlled trial

    Background: Knee osteoarthritis (OA) is a leading contributor to global disability, with exercise proven to be an effective treatment. Tai Chi is a recommended type of exercise, but it is primarily done in person which imposes an accessibility issue. This study aims to evaluate the effects of an online unsupervised program, when provided with online educational information and exercise adherence support, on changes in knee pain and physical function, when compared to online education control for people with knee OA.

    Shiyi Julia Zhu, Rachel K. Nelligan, Rana S. Hinman, Alexander J. Kimp, Peixuan Li, Anurika De Silva, Jenny Harrison, Kim L. Bennell·2024·Osteoarthritis and Cartilage Open
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  • SaveMySkin: An Internet-based self-help intervention for skin picking. Study protocol for a randomized pilot study

    Background: Skin picking disorder is an under-recognized and understudied mental disorder associated with severe psychological and medical consequences. Affected individuals barely receive adequate treatment, given the scarcity of expertise in healthcare professionals and the lack of evidence-based interventions.

    Christina Gallinat, Markus Moessner, Holger A. Haenssle, Julia K. Winkler, Matthias Backenstrass, Stephanie Bauer·2019·Contemporary Clinical Trials Communications
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  • Structural Brain Correlates of Childhood Inhibited Temperament: An ENIGMA-Anxiety Mega-analysis

    Janna Marie Bas-Hoogendam, Rachel Bernstein, Brenda E. Benson, Kristin A. Buss, Kelley E. Gunther, Koraly Pérez-Edgar, Giovanni A. Salum, Andrea P. Jackowski, Rodrigo A. Bressan, André Zugman, Kathryn A. Degnan, Courtney A. Filippi, Nathan A. Fox, Heather A. Henderson, Alva Tang, Selin Zeytinoglu, Anita Harrewijn, Manon H. J. Hillegers, Tonya White, Marinus H. van IJzendoorn, Carl E. Schwartz, Julia M. Felicione, Kathryn A. DeYoung, Alexander J. Shackman, Jason F. Smith, Rachael M. Tillman, Yvonne H. M. van den Berg, Antonius H. N. Cillessen, Karin Roelofs, Anna Tyborowska, Shirley Y. Hill, Marco Battaglia, Marco Tettamanti, Lea R. Dougherty, Jingwen Jin, Daniel N. Klein, Hoi-Chung Leung, Suzanne N. Avery, Jennifer Urbano Blackford, Jacqueline A. Clauss, Elizabeth P. Hayden, Pan Liu, Matthew R. J. Vandermeer, H. Hill Goldsmith, Elizabeth M. Planalp, Thomas E. Nichols, Paul M. Thompson, P. Michiel Westenberg, Nic J. A. van der Wee, Nynke A. Groenewold, Dan J. Stein, Anderson M. Winkler, Daniel S. Pine·2022·Journal of the American Academy of Child & Adolescent Psychiatry
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  • Do bank ties influence stock repurchases in a bank-based financial system during financial distress? A pre-registered report

    This pre-registered study seeks to investigate the effects of bank ties on corporate repurchase decisions and stock price reactions to buyback announcements. We make causal inferences to provide more insights into bank ties for stock repurchase decisions during extreme financial distress. We focus on the COVID-19 pandemic as an exogenous shock and identify whether the COVID-19 shock affected the bank-ties effect of the motives of stock repurchase decisions in a bank-based financial system. Our study sheds light on the motives behind stock repurchase decisions and the role of banks in corporate cash distribution to shareholders. Furthermore, our study contributes to understanding how extreme financial distress, such as COVID-19, affects the motive for stock repurchase in a bank-based financial system.

    Hideaki Sakawa, Naoki Watanabel, Konari Uchida·2024·Pacific-Basin Finance Journal
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  • Impact of an SMS advice programme on maternal and newborn health in rural China: study protocol for a quasi-randomised controlled trial

    Introduction Expectant mothers in low-income and middle-income countries often lack access to vital information about pregnancy, preparation for birth and best practices when caring for their newborn. Innovative solutions are needed to bridge this knowledge gap and dramatically improve maternal and neonatal health in these settings. This study aims to evaluate the impact of an innovative text messaging intervention on maternal and neonatal health outcomes. Methods and analysis This study offers expectant mothers in rural China a package of free short messages via cell phone regarding pregnancy and childbirth. These messages are tailored to each mother's gestational week. It is hypothesised that delivering these short advice messages to pregnant women can improve maternal and newborn health. The study uses factorial quasi-randomisation to compare psychological, behavioural and health outcomes between 4 groups: 2 groups receiving different sets of short message interventions (ie, good household prenatal practices and healthcare seeking), a group receiving both interventions and a control group. Treatment assignment occurs at the individual level. The primary outcome is newborn health, measured by appropriateness of weight for gestational age. Secondary outcomes include severe neonatal and maternal morbidity as well as psychological and behavioural measures. This study has enrolled pregnant women who attend county maternal and child health centres for their prenatal visits. Discussion This pilot is the first large-scale effort to build a comprehensive evidence base on the impact of prenatal text messages via cell phone on maternal and newborn health outcomes in China. The study has broad implications for public health policy in China and the implementation of mobile health interventions in low-resource settings around the world. Ethics This study was approved by the Ethics Committee of the School of Medicine at Xi'an Jiaotong University on 18 January 2013. Trial registration number NCT02037087; Pre-results.

    Yanfang Su, Changzheng Yuan, Zhongliang Zhou, Jesse Heitner, Benjamin Campbell·2016·BMJ Open
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  • Evaluating the Efficacy of a Web-Based Program (Diapason) for Informal Caregivers of Patients With Alzheimer’s Disease: Protocol for a Randomized Clinical Trial

    Background: Informal caregivers (CGs) of patients with Alzheimer’s disease are at risk of suffering from psychological and physical weakening. Several psychoeducational interventions have been designed to prevent stress and burden of caregivers. In France, despite health authorities’ recommendations, to our knowledge there is no rigorously assessed Web-based psychoeducational program to date. Objective: The objective of our study was to assess the efficacy of a French Web-based psychoeducational program (called Diapason) with an unblinded randomized clinical trial. Methods: In this protocol, 80 informal caregivers of patients followed at Broca Hospital are recruited offline and randomized in the experimental condition (EC) or the control condition (CC). The volunteers in EC have to visit a closed online user group at least once a week and validate one new session of this fully automated Web program, during 12 weeks. Each week a new thematic is added to the website. The participants in the CC receive usual care, and have access to the Diapason program after their participation (6 months). Face-to-face evaluations for both groups are planned every 3 months (M0–M3 and M6). The main objective of this program is to provide CGs with information on the disease process, how to prevent psychological strain (using anticipation and relaxation techniques), and offering a virtual space (forum) to discuss with other caregivers. The primary outcome of this study is the self-perceived stress, while self-efficacy, burden, depression, and self-perceived health status are defined as secondary outcomes. Other variables that might have an impact on the program efficacy are collected. Results: This protocol was accepted for funding. The enrollment began in October 2011, and participants currently recruited will finish their evaluations in January 2014. The results are expected for June 2014. Conclusions: Findings might provide empirical evidence on: (1) the feasibility of an Internet-based program in the French context, (2) the effectiveness of a Web-based program for informal caregivers, and (3) the identification of caregivers who will benefit from this type of intervention.

    Victoria Cristancho-Lacroix, Hélène Kerhervé, Jocelyne De Rotrou, Alexandra Rouquette, Grégory Legouverneur, Anne-Sophie Rigaud·2013·JMIR Research Protocols
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  • Mobile Apps for Health Behavior Change in Physical Activity, Diet, Drug and Alcohol Use, and Mental Health: Systematic Review

    Background: With a growing focus on patient interaction with health management, mobile apps are increasingly used to deliver behavioral health interventions. The large variation in these mobile health apps—their target patient group, health behavior, and behavioral change strategies—has resulted in a large but incohesive body of literature. Objective: This systematic review aimed to assess the effectiveness of mobile apps in improving health behaviors and outcomes and to examine the inclusion and effectiveness of behavior change techniques (BCTs) in mobile health apps. Methods: PubMed, EMBASE, CINAHL, and Web of Science were systematically searched for articles published between 2014 and 2019 that evaluated mobile apps for health behavior change. Two authors independently screened and selected studies according to the eligibility criteria. Data were extracted and the risk of bias was assessed by one reviewer and validated by a second reviewer. Results: A total of 52 randomized controlled trials met the inclusion criteria and were included in the analysis—37 studies focused on physical activity, diet, or a combination of both, 11 on drug and alcohol use, and 4 on mental health. Participant perceptions were generally positive—only one app was rated as less helpful and satisfactory than the control—and the studies that measured engagement and usability found relatively high study completion rates (mean 83%; n=18, N=39) and ease-of-use ratings (3 significantly better than control, 9/15 rated >70%). However, there was little evidence of changed behavior or health outcomes. Conclusions: There was no strong evidence in support of the effectiveness of mobile apps in improving health behaviors or outcomes because few studies found significant differences between the app and control groups. Further research is needed to identify the BCTs that are most effective at promoting behavior change. Improved reporting is necessary to accurately evaluate the mobile health app effectiveness and risk of bias.

    Madison Milne-Ives, Ching Lam, Caroline De Cock, Michelle Helena Van Velthoven, Edward Meinert·2020·JMIR mHealth and uHealth
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  • Stage1_Doc7_RevisedProposal2

    Ashley Whillans·2017
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  • Perceptions on artificial intelligence-based decision-making for coexisting multiple long-term health conditions: protocol for a qualitative study with patients and healthcare professionals

    Introduction Coexisting multiple health conditions is common among older people, a population that is increasing globally. The potential for polypharmacy, adverse events, drug interactions and development of additional health conditions complicates prescribing decisions for these patients. Artificial intelligence (AI)-generated decision-making tools may help guide clinical decisions in the context of multiple health conditions, by determining which of the multiple medication options is best. This study aims to explore the perceptions of healthcare professionals (HCPs) and patients on the use of AI in the management of multiple health conditions. Methods and analysis A qualitative study will be conducted using semistructured interviews. Adults (≥18 years) with multiple health conditions living in the West Midlands of England and HCPs with experience in caring for patients with multiple health conditions will be eligible and purposively sampled. Patients will be identified from Clinical Practice Research Datalink (CPRD) Aurum; CPRD will contact general practitioners who will in turn, send a letter to patients inviting them to take part. Eligible HCPs will be recruited through British HCP bodies and known contacts. Up to 30 patients and 30 HCPs will be recruited, until data saturation is achieved. Interviews will be in-person or virtual, audio recorded and transcribed verbatim. The topic guide is designed to explore participants’ attitudes towards AI-informed clinical decision-making to augment clinician-directed decision-making, the perceived advantages and disadvantages of both methods and attitudes towards risk management. Case vignettes comprising a common decision pathway for patients with multiple health conditions will be presented during each interview to invite participants’ opinions on how their experiences compare. Data will be analysed thematically using the Framework Method. Ethics and dissemination This study has been approved by the National Health Service Research Ethics Committee (Reference: 22/SC/0210). Written informed consent or verbal consent will be obtained prior to each interview. The findings from this study will be disseminated through peer-reviewed publications, conferences and lay summaries.

    Niluka Jeewanthi Gunathilaka, Tiffany E Gooden, Jennifer Cooper, Sarah Flanagan, Tom Marshall, Shamil Haroon, Alexander D’Elia, Francesca Crowe, Thomas Jackson, Krishnarajah Nirantharakumar, Sheila Greenfield·2024·BMJ Open
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  • Effectiveness of Interventions to Improve Digital Health Literacy in Forced Migrant Populations: Protocol for a Mixed Methods Systematic Review

    Background: Digital health literacy is considered a health determinant that can influence improved health and well-being, health equity, and the reduction of social health inequalities. Therefore, it serves as an asset for individuals to promote their health. However, low digital health literacy is a major problem among forced migrant populations. They do not always have the capacity and skills to access digital health resources and use them appropriately. To our knowledge, no studies are currently available to examine effective interventions for improving digital health literacy among forced migrant populations. Objective: This paper presents the protocol for a systematic review that aims to assess the effectiveness of digital health literacy interventions among forced migrant populations. With this review, our objectives are as follows: (1) identify interventions designed to improve digital health literacy among forced migrant populations, including interventions aimed at creating enabling conditions or environments that cater to the needs and expectations of forced migrants limited by low levels of digital health literacy, with the goal of facilitating their access to and use of eHealth resources; (2) define the categories and describe the characteristics of these interventions, which are designed to enhance the abilities of forced migrants or adapt digital health services to meet the needs and expectations of forced migrant populations. Methods: A mixed methods systematic review will be conducted according to the PRISMA-P (Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols) checklist. The research will be conducted in an iterative process among the different authors. With the help of a medical information specialist, a specific search strategy will be formulated for the 6 most relevant databases (ie, MEDLINE, Embase, CINAHL, Web of Science, Academic Search Premier, PsycINFO, and the Google Scholar search engine). A literature search covering studies published between 2000 and 2022 has already been conducted. Two reviewers then proceeded, individually and independently, to conduct a double selection of titles, abstracts, and then full texts. Data extraction will be conducted by a reviewer and validated by a senior researcher. We will use the narrative synthesis method (ie, structured narrative summaries of key themes) to present a comprehensive picture of effective digital health literacy interventions among forced migrant populations and the success factors of these interventions. Results: The search strategy and literature search were completed in December 2022. A total of 1232 articles were identified. The first selection was completed in July 2023. The second selection is still in progress. The publication of the systematic review is scheduled for December 2023. Conclusions: This mixed methods systematic review will provide comprehensive knowledge on effective interventions for digital literacy among forced migrant populations. The evidence generated will further inform stakeholders and aid decision makers in promoting equitable access to and use of digital health resources for forced migrant populations and the general population in host countries.

    Achille Roghemrazangba Yameogo, Carole Délétroz, Maxime Sasseville, Samira Amil, Sié Mathieu Aymar Romaric Da, Patrick Bodenmann, Marie-Pierre Gagnon·2023·JMIR Research Protocols
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  • Low-Intensity Self-Management Intervention for Persons With Type 2 Diabetes Using a Mobile Phone-Based Diabetes Diary, With and Without Health Counseling and Motivational Interviewing: Protocol for a Randomized Controlled Trial

    Background: The present study protocol is designed to cover the Norwegian part of the European Union Collaborative Project—REgioNs of Europe WorkINg together for HEALTH (RENEWING HEALTH). Self-management support is an important element of care for persons with type 2 diabetes (T2D) for achieving metabolic control and positive lifestyle changes. Telemedicine (TM) with or without health counseling may become an important technological aid for self-management and may provide a user-centered model of care. In spite of many earlier studies on TM, there remains a lack of consensus in research findings about the effect of TM interventions. Objective: The aim of RENEWING HEALTH is to validate and evaluate innovative TM tools on a large scale through a common evaluation, making it easier for decision makers to choose the most efficient and cost-effective technological interventions. The Norwegian pilot study evaluates whether the introduction of a mobile phone with a diabetes diary application together with health counseling intervention produces benefits in terms of the desired outcomes, as reflected in the hemoglobin A1c level, health-related quality of life, behavior change, and cost-effectiveness. Methods: The present study has a mixed-method design comprising a three-armed prospective randomized controlled trial and qualitative interviews with study data collected at three time points: baseline, after 4 months, and after 1 year. The patients’ registrations on the application are recorded continuously and are sent securely to a server. Results: The inclusion of patients started in March 2011, and 100% of the planned sample size is included (N=151). Of all the participants, 26/151 patients (17.2%) are lost to follow-up by now, and 11/151 patients (7.3%) are still in the trial. Results of the study protocol will be presented in 2014. Conclusions: The key goals of this trial are to investigate the effect of an electronic diabetes diary app with and without health counseling, and to determine whether health counseling is important to the continued use of the application and the patients’ health competence and acceptability. Research within this area is needed because few studies have investigated the effectiveness of apps used in long-term interventions with this degree of self-management. Trial Registration: Clinicaltrials.gov NCT01315756; http://clinicaltrials.gov/ct2/show/NCT01315756 (Archived by WebCite at http://www.webcitation/6BTyuRMpH).

    Lis Ribu, Heidi Holmen, Astrid Torbjørnsen, Astrid Klopstad Wahl, Astrid Grøttland, Milada Cvancarova Småstuen, Elisabeth Elind, Trine Strand Bergmo, Elin Breivik, Eirik Årsand·2013·JMIR Research Protocols
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  • Community-Based Rehabilitation Post Hospital Discharge Interventions for Older Adults With Cognitive Impairment Following a Hip Fracture: A Systematic Review Protocol

    Background: Hip fractures among older adults remain a public concern. Consequences of a hip fracture include the subsequent decline in function and mobility for the older adult, and an increased burden placed upon their caregivers and the health care system. The consequences may be more challenging if an older adult also has a compromised cognitive reserve. Although rehabilitation programs have proven effective, the best practices and resources required to maintain the gains in function and mobility, to negate diminution of effect, and to enable this patient population to continue living at home are currently unknown. Objective: The objective of this study is to develop a systematic review protocol focused on identifying the evidence and evaluating the effectiveness of post discharge rehabilitation programs for older adults with a cognitive impairment following a hip fracture. Methods: The search strategy will include a combination of text words and subject headings relating to the concepts of cognitive impairment, dementia, delirium, cognitive reserve, and hip fractures. Searching various databases will identify peer-reviewed journal articles. There will be two independent reviewers who will screen the titles and abstracts to determine which articles comprise a rehabilitation intervention within a community setting prior to being included for a full article review. A data extraction form and an evidence and quality checklist will be used during the full article data analysis and synthesis. It is expected that there will be a paucity of studies that focus on post discharge rehabilitation interventions for older adults with cognitive impairment following a hip fracture, and few studies that use the same or similar outcome measures. However, if possible, a meta-analysis will be conducted on studies that used similar outcome methods. Results: This review will synthesize knowledge focusing on activities to maintain and restore function in older adult patients with cognitive impairment once they have completed their active rehabilitation program and return home. A synthesis of the findings will be conducted to determine which components of the interventions identified were the most advantageous to the patient population. The results will be used to develop a multi-faceted post discharge rehabilitation intervention aimed at enabling older adults to return and remain living at home after a hip fracture. Conclusions: The aim of this systematic review is to generate results that can be used to create interventions that focus on the care necessary to enable older adults to remain living at home post discharge from acute or inpatient rehabilitation care for a hip fracture. With the support and contributions by our associated knowledge users, this systematic review will be used to help inform procedures and policies to facilitate the necessary care and resources required by our patient population.

    Paula M. van Wyk, Charlene H. Chu, Jessica Babineau, Martine Puts, Dina Brooks, Marianne Saragosa, Katherine S. McGilton·2014·JMIR Research Protocols
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  • Development of a Mobile Phone-Based Weight Loss Lifestyle Intervention for Filipino Americans with Type 2 Diabetes: Protocol and Early Results From the PilAm Go4Health Randomized Controlled Trial

    Background: Filipino Americans are the second largest Asian subgroup in the United States, and were found to have the highest prevalence of obesity and type 2 diabetes (T2D) compared to all Asian subgroups and non-Hispanic whites. In addition to genetic factors, risk factors for Filipinos that contribute to this health disparity include high sedentary rates and high fat diets. However, Filipinos are seriously underrepresented in preventive health research. Research is needed to identify effective interventions to reduce Filipino diabetes risks, subsequent comorbidities, and premature death. Objective: The overall goal of this project is to assess the feasibility and potential efficacy of the Filipino Americans Go4Health Weight Loss Program (PilAm Go4Health). This program is a culturally adapted weight loss lifestyle intervention, using digital technology for Filipinos with T2D, to reduce their risk for metabolic syndrome. Methods: This study was a 3-month mobile phone-based pilot randomized controlled trial (RCT) weight loss intervention with a wait list active control, followed by a 3-month maintenance phase design for 45 overweight Filipinos with T2D. Participants were randomized to an intervention group (n=22) or active control group (n=23), and analyses of the results are underway. The primary outcome will be percent weight change of the participants, and secondary outcomes will include changes in waist circumference, fasting plasma glucose, glycated hemoglobin A1c, physical activity, fat intake, and sugar-sweetened beverage intake. Data analyses will include descriptive statistics to describe sample characteristics and a feasibility assessment based on recruitment, adherence, and retention. Chi-square, Fisher's exact tests, t-tests, and nonparametric rank tests will be used to assess characteristics of randomized groups. Primary analyses will use analysis of covariance and linear mixed models to compare primary and secondary outcomes at 3 months, compared by arm and controlled for baseline levels. Results: Recruitment was completed in January, 2016, and participant follow-up continued through June, 2016. At baseline, mean age was 57 years, 100% (45/45) of participants self-identified as Filipinos, and the cohort was comprised of 17 males and 28 females. Overall, participants were obese with a baseline mean body mass index of 30.2 kg/m2 (standard deviation 4.9). The majority of participants were immigrants (84%, 38/45), with 47% (21/45) living in the United States for more than 10 years. One third of all participants (33%, 15/45) had previously used a pedometer. Conclusions: This study will provide preliminary evidence to determine if the PilAm Go4Health weight loss lifestyle intervention is feasible, and if the program demonstrates potential efficacy to reduce risks for metabolic syndrome in Filipinos with T2D. Positive results will lend support for a larger RCT to evaluate the effectiveness of the PilAm Go4Health intervention for Filipinos. ClinicalTrial: ClinicalTrials.gov: NCT02290184; https://clinicaltrials.gov/ct2/show/NCT02290184 (Archived at http://www.webcitation.org/6k1kUqKSP)

    Melinda Sarmiento Bender, Glenn-Milo Santos, Carissa Villanueva, Shoshana Arai·2016·JMIR Research Protocols
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  • Assessment of Active Video Gaming Using Adapted Controllers by Individuals With Physical Disabilities: A Protocol

    Background: Individuals with disabilities are typically more sedentary and less fit compared to their peers without disabilities. Furthermore, engaging in physical activity can be extremely challenging due to physical impairments associated with disability and fewer opportunities to participate. One option for increasing physical activity is playing active video games (AVG), a category of video games that requires much more body movement for successful play than conventional push-button or joystick actions. However, many current AVGs are inaccessible or offer limited play options for individuals who are unable to stand, have balance issues, poor motor control, or cannot use their lower body to perform game activities. Making AVGs accessible to people with disabilities offers an innovative approach to overcoming various barriers to participation in physical activity. Objective: Our aim was to compare the effect of off-the-shelf and adapted game controllers on quality of game play, enjoyment, and energy expenditure during active video gaming in persons with physical disabilities, specifically those with mobility impairments (ie, unable to stand, balance issues, poor motor control, unable to use lower extremity for gameplay). The gaming controllers to be evaluated include off-the-shelf and adapted versions of the Wii Fit balance board and gaming mat. Methods: Participants (10-60 years old) came to the laboratory a total of three times. During the first visit, participants completed a functional assessment and became familiar with the equipment and games to be played. For the functional assessment, participants performed 18 functional movement tasks from the International Classification of Functioning, Disability, and Health. They also answered a series of questions from the Patient Reported Outcomes Measurement Information System and Quality of Life in Neurological Conditions measurement tools, to provide a personal perspective regarding their own functional ability. For Visit 2, metabolic data were collected during an initial 20-minute baseline, followed by 40 minutes of game play. The controller (balance board or gaming mat) played was randomly selected. A set of games was played for 10 minutes, followed by 5 minutes of rest, and then another set of games was played for 10 minutes, followed by rest. Quality of game play was observed and documented for each set. During rest, the participant completed questions regarding enjoyment. Following the same procedures, the participant then played the two sets of games using the other version (off-the-shelf or adapted) of the controller. The entire procedure was repeated during Visit 3 with the controller that was not played. Results: Enrollment began in February 2016 and ended in September 2016. Study results will be reported in late 2017. Conclusions: We hypothesized that the adapted versions of the Wii Fit balance board and gaming mat would produce greater quality of game play, enjoyment, and energy expenditure in persons with mobility impairments compared to off-the-shelf versions. Trial Registration: ClinicalTrials.gov NCT02994199; https://clinicaltrials.gov/ct2/show/NCT02994199 (Archived by WebCite at http://www.webcitation.org/6qpPszPJ7)

    Laurie A. Malone, Sangeetha Padalabalanarayanan, Justin McCroskey, Mohanraj Thirumalai·2017·JMIR Research Protocols
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  • Development of a Path to Home Mobile App for the Geriatric Rehabilitation Program at Bruyère Continuing Care: Protocol for User-Centered Design and Feasibility Testing Studies

    Background: As the population ages, the need for appropriate geriatric rehabilitation services will also increase. Pressures faced by hospitals to reduce length of stay and reduce costs have driven the need for more complex care being delivered in the home or community setting. As a result, a multifaceted approach that can provide geriatric rehabilitation patients with safe and effective person- and family-centered care during transitions from hospital to home is required. We hypothesize that a technology-supported person- and family-centered care transition could empower geriatric rehabilitation patients, engage them in shared decision making, and ultimately help them to safely manage their personalized needs during care transitions from hospital to home. Objective: The purpose of this study is to design and test the feasibility of a novel Path to Home mobile app to manage the personalized needs of geriatric rehabilitation patients during their transitions from hospital to home. Methods: This study will consist of (1) codesigning a patient- and provider-tailored mobile app, and (2) feasibility pilot testing of the mobile app to manage the needs of geriatric rehabilitation patients when leaving the hospital. In phase 1, we will follow a user-centered design process integrated with a modern agile software development methodology to iteratively codesign the personalized care transition Path to Home mobile app. In phase 2, we will conduct a single-arm feasibility pilot test with geriatric rehabilitation patients using the personalized care transition Path to Home mobile app to manage their needs during the transition from hospital to home. Results: The project was funded in May 2018, and enrollment and data analysis are underway. First results are expected to be submitted for publication in 2019. Conclusions: Our findings will help validate the use of this technology for geriatric rehabilitation patients discharged from the hospital to home. Future research will more rigorously evaluate the health and economic benefits to inform wide-scale adoption of the technology. Registered Report Identifier: RR1-10.2196/11031

    Chantal Backman, Anne Harley, Liam Peyton, Craig Kuziemsky, Jay Mercer, Mary Anne Monahan, Sandra Schmidt, Harvinder Singh, Deborah Gravelle·2018·JMIR Research Protocols
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  • Modifications after preregistration from reviewer feedback.docx

    Matthew Goldberg, Cheryl Carmichael·2017
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  • Rationale and design of a systematic review: effectiveness and acceptance of technology-based psychological interventions in different clinical phases of depression management

    Introduction Although many effective treatment options exist, depression is still undertreated indicating gaps in the healthcare system. The complementary provision of mental healthcare through technologies (eg, computer, smartphone) has the potential to fill treatment gaps and to overcome access barriers to mental healthcare. Until now, no systematic review integrates the evidence on different technology-based psychological interventions (TBIs) concerning their effectiveness and acceptance in different clinical phases of depression management (bridging waiting periods, acute treatment and aftercare). The aim of this project is to structure evidence on TBIs regarding different phases of depression management, and to determine effectiveness and acceptance for each clinical phase considering both active (eg, face-to-face treatment) and inactive (eg, waitlist) controls as comparators. Methods and analysis We will include studies on adults with a formal diagnosis of unipolar depression. Treatments delivered by technologies based on scientific psychological theories will be considered as experimental interventions. The primary effectiveness outcome will be depressive symptoms at study endpoint measured by symptom severity rating scales, and the primary acceptance outcome will be dropping out of the study due to any reason. We will consider only randomised controlled trials, which will be identified by key database searches (including Cochrane Central Register of Controlled Trials, Medline, PsycINFO, PSYNDEX, CINAHL) complemented through searches in clinical trial registries (eg, clinicaltrials.gov) and grey literature searches (eg, Open Grey). Two review authors will independently conduct study selection, data extraction and quality assessment of included studies (using the Cochrane Collaboration’s tool for assessing risk of bias). Meta-analyses applying random-effect models as well as subgroup, meta-regression and sensitivity analyses will be performed. Ethics and dissemination Ethics approval is not required for this study, as we conduct research on secondary data. We will disseminate results via peer-reviewed journal publications, presentations on conferences and via plain language summaries. PROSPERO registration number CRD42016050413; Pre-results.

    Moritz Köhnen, Levente Kriston, Martin Härter, Jörg Dirmaier, Sarah Liebherz·2019
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  • A Smartphone Attention Bias Intervention for Individuals With Addictive Disorders: Protocol for a Feasibility Study

    Background: Substance use disorders are highly prevalent globally. Relapse rates following conventional psychological interventions for substance use disorders remain high. Recent reviews have highlighted attentional and approach or avoidance biases to be responsible for multiple relapses. Other studies have reported the efficacy of interventions to modify biases. With advances in technologies, there are now mobile versions of conventional bias modification interventions. However, to date, no study has evaluated bias modification in a substance-using, non-Western sample. Existing evaluations of mobile technologies for the delivery of bias interventions are also limited to alcohol or tobacco use disorders. Objective: This study aims to examine the feasibility of mobile-based attention bias modification intervention among treatment-seeking individuals with substance use and alcohol use disorders. Methods: This is a feasibility study, in which inpatients who are in their rehabilitation phase of clinical management will be recruited. On each day that they are in the study, they will be required to complete a craving visual analogue scale and undertake both a visual probe-based assessment and and modification task in a smartphone app . Reaction time data will be collated for the computation of baseline attentional biases and to determine whether there is a reduction of attentional bias across the interventions. Feasibility will be determined by the number of participants recruited and participants’ adherence to the planned interventions up until the completion of their rehabilitation program and by the ability of the app in detecting baseline biases and changes in biases. Acceptability of the intervention will be assessed by a short questionnaire of users’ perceptions of the intervention. Statistical analyses will be performed using SPSS version 22.0, while qualitative analysis of the perspectives will be performed using NVivo version 10.0. Results: This study was approved by the National Healthcare Group Domain Specific Research Board, with approval number (2018/00316). Results will be disseminated by means of conferences and publications.Currently, we are in the process of recruitment for this study. Conclusions: To the best of our knowledge, this is the first study to evaluate the feasibility and acceptability of a mobile attention bias modification intervention for individuals with substance use disorders. The data pertaining to the feasibility and acceptability are undoubtedly crucial because they imply the potential use of mobile technologies in retraining attentional biases among inpatients admitted for medical-assisted detoxification and rehabilitation. Participants’ feedback pertaining to the ease of use, interactivity, and motivation to continue using the app is crucial because it will determine whether a codesign approach might be warranted to design an app that is acceptable for participants and that participants themselves would be motivated to use. International Registered Report Identifier (IRRID): PRR1-10.2196/11822

    Melvyn Zhang, Jiangbo Ying, Syidda B. Amron, Zaakira Mahreen, Guo Song, Daniel SS Fung, Helen Smith·2018·JMIR Research Protocols
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  • Protocol for a multicenter, real-world study of HIV pre-exposure prophylaxis among men who have sex with men in China (CROPrEP)

    Pre-exposure prophylaxis (PrEP) is a promising and effective tool to prevent human immunodeficiency virus (HIV) transmission; however, context-specific data to guide optimal implementation are currently lacking in China. This study aims to systematically collect comprehensive, empirical data to determine effective ways to implement PrEP among at-risk men who have sex with men (MSM) in China.

    Hongyi Wang, Yonghui Zhang, Zhu Mei, Yueru Jia, Sequoia I. Leuba, Jing Zhang, Zhenxing Chu, Haibo Ding, Yongjun Jiang, Wenqing Geng, Hong Shang, Junjie Xu·2019·BMC Infectious Diseases
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  • Mobile health intervention for self-management of adolescent chronic pain (WebMAP mobile): Protocol for a hybrid effectiveness-implementation cluster randomized controlled trial

    Introduction Approximately 5–8% of children report severe chronic pain and disability. Although evidence supports pain-self management as effective for reducing pain and disability, most youth do not have access to psychological intervention. Our prior studies demonstrate that an existing internet-delivered pain self-management program (WebMAP) can reduce barriers to care, is feasible, acceptable, and is effective in reducing pain-related disability in youth with chronic pain. The current trial seeks to: 1) determine the effectiveness of a mobile app version of WebMAP for improving patient pain-related outcomes, and 2) evaluate a novel implementation strategy to maximize the public health impact of the intervention including the determination of adoption, reach, and sustainability of WebMAP in specialty clinics serving children with chronic pain in the United States. Methods This hybrid effectiveness-implementation cluster randomized controlled trial employs a stepped wedge design in which the WebMAP mobile intervention is sequentially implemented in 8 specialty pain clinics following a usual care period. This trial aims to enroll a minimum of 120 youth (ages 10–17) who have chronic pain. Outcome analyses will determine effectiveness of treatment on adolescent pain-related outcomes as well as public health impact via reach, adoption, implementation, and maintenance. Conclusions This trial examines an innovative approach to evaluate a technology-delivered pain self-management program for youth with chronic pain. Findings are expected to yield a strategic approach for delivering a digital pain management program for youth with chronic pain that can be sustained in clinical settings. Clinical Trial Registration #: NCT03332563

    Tonya M. Palermo, Rocio de la Vega, Joanne Dudeney, Caitlin Murray, Emily Law·2018·Contemporary Clinical Trials
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  • Heal-me PiONEer (personalized online nutrition and exercise): An RCT assessing 2 levels of app-based programming in individuals with chronic disease

    Background App-based strategies are a promising solution to deliver nutrition and exercise interventions during social distancing. With limited RCT data in individuals with chronic disease, further information is required both to determine impact, and to guide delivery. The Heal-Me app is an evidence-based, theoretically informed nutrition and exercise solution that can be tailored for use across a range of individuals with chronic disease. As compared to controls receiving educational material, the aim of this study is to assess the acceptability, effectiveness, and cost of Heal-Me app programming delivered alongside two levels of dietitian and exercise-specialist support. Methods Heal-Me PiONEer is a 12-week, 3-arm RCT with randomization to one of three study groups (n=72 per group, 216 total). Group 1 (control: educational material), Group 2 (Heal-Me app + virtual group dietitian/exercise-specialist sessions), Group 3 (Heal-Me app + virtual group and 1-to-1 dietitian/exercise-specialist sessions). Inclusion criteria: adults with cancer, chronic lung disease or status post-transplantation from liver or lung transplant; previous completion of an exercise rehabilitation program; access to an internet-connected device. Study outcomes measured at study weeks 0 and 12 include: Primary - Lower Extremity Functional Scale; Secondary – virtual physical function tests, loneliness, resilience, anxiety, well-being and health-related quality of life; Exploratory outcomes – protein intake, behavioral beliefs around exercise and nutrition, adherence, adverse events, acceptability, and cost-utility. Conclusions The Heal-Me PiONEer RCT holds promise to provide a comprehensive understanding of the delivery and impact of app-based nutrition and exercise programming in a diverse group of participants with chronic disease.

    Puneeta Tandon, Graeme Purdy, Kathleen P. Ismond, Christofer Cruz, Evelyn Etruw, Kirsten Suderman, Ashley Hyde, Michael Stickland, John C. Spence, Dale C. Lien, Rahima Bhanji, Carla M. Prado, Antonio Miguel Cruz, Anil A. Joy, Maryna Yaskina, Jeff Round, Kate Harback, Raj Padwal, Margaret L. McNeely·2022·Contemporary Clinical Trials
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  • Assessing the impact of online postal self-sampling for sexually transmitted infections on health inequalities, access to care and clinical outcomes in the UK: protocol for ASSIST, a realist evaluation

    Introduction The past decade has seen a rapid increase in the volume and proportion of testing for sexually transmitted infections that are accessed via online postal self-sampling services in the UK. ASSIST (Assessing the impact of online postal self-sampling for sexually transmitted infections on health inequalities, access to care and clinical outcomes in the UK) aims to assess the impact of these services on health inequalities, access to care, and clinical and economic outcomes, and to identify the factors that influence the implementation and sustainability of these services. Methods and analysis ASSIST is a mixed-methods, realist evaluated, national study with an in-depth focus of three case study areas (Birmingham, London and Sheffield). An impact evaluation, economic evaluation and implementation evaluation will be conducted. Findings from these evaluations will be analysed together to develop programme theories that explain the outcomes. Data collection includes quantitative data (using national, clinic based and online datasets); qualitative interviews with service users, healthcare professionals and key stakeholders; contextual observations and documentary analysis. STATA 17 and NVivo will be used to conduct the quantitative and qualitative analysis, respectively. Ethics and dissemination This study has been approved by South Central – Berkshire Research Ethics Committee (ref: 21/SC/0223). All quantitative data accessed and collected will be anonymous. Participants involved with qualitative interviews will be asked for informed consent, and data collected will be anonymised.Our dissemination strategy has been developed to access and engage key audiences in a timely manner and findings will be disseminated via the study website, social media, in peer-reviewed scientific journals, at research conferences, local meetings and seminars and at a concluding dissemination and networking event for stakeholders.

    Jo Gibbs, Alison R. Howarth, Jessica Sheringham, Louise J. Jackson, Geoff Wong, Andrew Copas, David J. Crundwell, Catherine H. Mercer, Hamish Mohammed, Jonathan Ross, Ann K. Sullivan, Elizabeth Murray, Fiona M. Burns·2022·BMJ Open
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  • Predicting Appropriate Admission of Bronchiolitis Patients in the Emergency Department: Rationale and Methods

    Background: In young children, bronchiolitis is the most common illness resulting in hospitalization. For children less than age 2, bronchiolitis incurs an annual total inpatient cost of $1.73 billion. Each year in the United States, 287,000 emergency department (ED) visits occur because of bronchiolitis, with a hospital admission rate of 32%-40%. Due to a lack of evidence and objective criteria for managing bronchiolitis, ED disposition decisions (hospital admission or discharge to home) are often made subjectively, resulting in significant practice variation. Studies reviewing admission need suggest that up to 29% of admissions from the ED are unnecessary. About 6% of ED discharges for bronchiolitis result in ED returns with admission. These inappropriate dispositions waste limited health care resources, increase patient and parental distress, expose patients to iatrogenic risks, and worsen outcomes. Existing clinical guidelines for bronchiolitis offer limited improvement in patient outcomes. Methodological shortcomings include that the guidelines provide no specific thresholds for ED decisions to admit or to discharge, have an insufficient level of detail, and do not account for differences in patient and illness characteristics including co-morbidities. Predictive models are frequently used to complement clinical guidelines, reduce practice variation, and improve clinicians’ decision making. Used in real time, predictive models can present objective criteria supported by historical data for an individualized disease management plan and guide admission decisions. However, existing predictive models for ED patients with bronchiolitis have limitations, including low accuracy and the assumption that the actual ED disposition decision was appropriate. To date, no operational definition of appropriate admission exists. No model has been built based on appropriate admissions, which include both actual admissions that were necessary and actual ED discharges that were unsafe. Objective: The goal of this study is to develop a predictive model to guide appropriate hospital admission for ED patients with bronchiolitis. Methods: This study will: (1) develop an operational definition of appropriate hospital admission for ED patients with bronchiolitis, (2) develop and test the accuracy of a new model to predict appropriate hospital admission for an ED patient with bronchiolitis, and (3) conduct simulations to estimate the impact of using the model on bronchiolitis outcomes. Results: We are currently extracting administrative and clinical data from the enterprise data warehouse of an integrated health care system. Our goal is to finish this study by the end of 2019. Conclusions: This study will produce a new predictive model that can be operationalized to guide and improve disposition decisions for ED patients with bronchiolitis. Broad use of the model would reduce iatrogenic risk, patient and parental distress, health care use, and costs and improve outcomes for bronchiolitis patients.

    Gang Luo, Bryan L. Stone, Michael D. Johnson, Flory L. Nkoy·2016·JMIR Research Protocols
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  • Brief Exercise Counseling and High-Intensity Interval Training on Physical Activity Adherence and Cardiometabolic Health in Individuals at Risk of Type 2 Diabetes: Protocol for a Randomized Controlled Trial

    Background: Worldwide incidence of type 2 diabetes (T2D) is rapidly increasing. Given the numerous negative health consequences associated with T2D, prevention of this disease has become a priority. Lifestyle changes, including regular exercise, can reduce the onset of T2D in those at elevated risk. However, long-term adherence to exercise is often poor in this population. Existing lifestyle interventions targeting exercise are labor intensive and costly for staff and participants. Evidence-informed counseling delivered in a manner that reduces dependence on staff and facilitates self-regulatory skills could alleviate time and financial barriers while promoting independent exercise. Objective: This protocol outlines the design, recruitment, and proposed analysis of a brief, 2-week evidence-informed exercise counseling intervention combined with either high-intensity interval training (HIIT) or traditional moderate-intensity continuous training (MICT). Methods: Small Steps for Big Changes is a 2-arm randomized controlled trial that will examine the effectiveness of combining brief exercise counseling with HIIT or MICT on adherence to moderate and vigorous exercise over 1 year. Cardiorespiratory fitness will be assessed at baseline, post intervention (2 weeks), and at 6- and 12-month follow-up. Physical activity behavior will be examined at baseline, post intervention, and 3-, 6-, 9-, and 12-month follow-up. The impact of the intervention on psychosocial outcomes pertinent to exercise adherence will be examined. Results: Data collection was complete in March 2017. Data analysis is currently underway, and the first results are expected to be submitted for publication in 2019. Conclusions: The results of this brief intervention have the potential to inform future public health efforts designed to increase exercise in individuals at risk of T2D. Trial Registration: ClinicalTrials.gov NCT02164474; https://clinicaltrials.gov/ct2/show/NCT02164474 (Archived by WebCite at http://www.webcitation.org/74Hx1ipj6) International Registered Report Identifier (IRRID): DERR1-10.2196/11226

    Jessica E. Bourne, Jonathan P. Little, Mark R. Beauchamp, Julianne Barry, Joel Singer, Mary E. Jung·2019·JMIR Research Protocols
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  • Internet-based support for self-management strategies for people with COPD–protocol for a controlled pragmatic pilot trial of effectiveness and a process evaluation in primary healthcare

    Introduction The use of adequate self-management strategies for people with chronic obstructive pulmonary disease (COPD) reduces healthcare use, improves health-related quality of life (HRQoL) and recovery after acute exacerbations. However, not many people with COPD receive support that promotes the use of such strategies and therefore new methods to facilitate and promote the use of self-management strategies are highly warranted. This pilot trial aims to evaluate the feasibility of the study design and study procedures considering effectiveness of the novel intervention, the COPD-web. Methods and analysis The overall design is a pragmatic controlled pilot trial with preassessments and postassessments and a parallel process evaluation. Patients with the diagnosis of COPD will be eligible for the study. The intervention group will be recruited when visiting one of the six participating primary care units in Sweden. The control group will be identified from the unit's computerised registers. The intervention, the COPD-web, is an interactive web page with two sections; one directed at people with COPD and one at healthcare professionals. The sections aim to support patients’ self-management skills—and to facilitate the provision of support for self-management strategies, respectively. Effectiveness with regard to patients’ symptoms, HRQoL, knowledge of and readiness for COPD-related self-management, health literacy, self-efficacy for physical activity and time spent in physical activity and time being sedentary, and further, healthcare professionals’ knowledge of and readiness to support COPD-related self-management strategies will be assessed using questionnaires at 3 and 12 months. The process evaluation will include observations and interviews. Ethics and dissemination Ethical approval has been obtained. Findings will be presented at conferences, submitted for publication in peer-reviewed publications and presented to the involved healthcare professionals, patients and to patient organisations. Trial registration number ClinicalTrials.gov: NCT02696187

    André Nyberg, Karin Wadell, Helena Lindgren, Malin Tistad·2017·BMJ Open
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  • Treatment of depression and anxiety with internet-based cognitive behavior therapy in patients with a recent myocardial infarction (U-CARE Heart): study protocol for a randomized controlled trial

    Major depression and depressive symptoms are common in patients with a recent myocardial infarction (MI), and depression is associated with adverse cardiovascular outcomes. Anxiety post-MI is less studied, but occurs commonly in patients with heart disease, and is also considered a risk factor for recurrence of cardiac events. Cognitive behavior therapy (CBT) is an established therapy for depression and anxiety disorders. To the best of our knowledge, there have not been any studies to determine if internet-based CBT (iCBT) can reduce the symptoms of depression and anxiety in patients with a recent MI. The main aim of the U-CARE Heart trial is to evaluate an iCBT intervention for patients with a recent MI.

    Fredrika Norlund, Erik MG Olsson, Gunilla Burell, Emma Wallin, Claes Held·2015·Trials
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  • SCALE-UP II: protocol for a pragmatic randomised trial examining population health management interventions to increase the uptake of at-home COVID-19 testing in community health centres

    Introduction SCALE-UP II aims to investigate the effectiveness of population health management interventions using text messaging (TM), chatbots and patient navigation (PN) in increasing the uptake of at-home COVID-19 testing among patients in historically marginalised communities, specifically, those receiving care at community health centres (CHCs). Methods and analysis The trial is a multisite, randomised pragmatic clinical trial. Eligible patients are >18 years old with a primary care visit in the last 3 years at one of the participating CHCs. Demographic data will be obtained from CHC electronic health records. Patients will be randomised to one of two factorial designs based on smartphone ownership. Patients who self-report replying to a text message that they have a smartphone will be randomised in a 2×2×2 factorial fashion to receive (1) chatbot or TM; (2) PN (yes or no); and (3) repeated offers to interact with the interventions every 10 or 30 days. Participants who do not self-report as having a smartphone will be randomised in a 2×2 factorial fashion to receive (1) TM with or without PN; and (2) repeated offers every 10 or 30 days. The interventions will be sent in English or Spanish, with an option to request at-home COVID-19 test kits. The primary outcome is the proportion of participants using at-home COVID-19 tests during a 90-day follow-up. The study will evaluate the main effects and interactions among interventions, implementation outcomes and predictors and moderators of study outcomes. Statistical analyses will include logistic regression, stratified subgroup analyses and adjustment for stratification factors. Ethics and dissemination The protocol was approved by the University of Utah Institutional Review Board. On completion, study data will be made available in compliance with National Institutes of Health data sharing policies. Results will be disseminated through study partners and peer-reviewed publications. Trial registration number ClinicalTrials.gov: NCT05533918 and NCT05533359.

    Guilherme Del Fiol, Brian Orleans, Tatyana V. Kuzmenko, Jonathan Chipman, Tom Greene, Anna Martinez, Jennifer Wirth, Ray Meads, Kimberly K. Kaphingst, Bryan Gibson, Kensaku Kawamoto, Andy J. King, Tracey Siaperas, Shlisa Hughes, Alan Pruhs, Courtney Pariera Dinkins, Cho Y. Lam, Joni H. Pierce, Ryzen Benson, Emerson P. Borsato, Ryan Cornia, Leticia Stevens, Richard L. Bradshaw, Chelsey R. Schlechter, David W. Wetter·2024·BMJ Open
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  • Protocol for a systematic review and qualitative synthesis of information quality frameworks in eHealth

    Introduction Electronic health (eHealth) applications have become a very large repository of health information which informs critical decisions relating to the diagnosis, treatment and prognosis of patients. Poor information quality (IQ) within eHealth may compromise patient safety. Evaluation of IQ in eHealth is therefore necessary to promote patient safety. An IQ framework specifies what aspects of information to assess and how to conduct the assessment. This systematic review aims to identify dimensions within existing IQ frameworks in eHealth and develop a new IQ framework for the assessment of eHealth. Method and analysis We will search Embase, Medline, PubMed, Cumulative Index to Nursing and Allied Health Literature, Maternity and Infant Care, PsycINFO (American Psychological Association), Global Health, Scopus, ProQuest Dissertations and Theses Global, Health Management Information Consortium and reference lists of relevant publications for articles published in English until November 2018. Studies will be selected by two independent reviewers based on prespecified eligibility criteria. Two reviewers will independently extract data in each eligible study using a prepiloted Microsoft Excel data extraction form. Thematic synthesis will be employed to define IQ dimensions and develop a new IQ framework for eHealth. Ethics and dissemination Ethical approval is not required for this systematic review as primary data will not be collected. The result of the review will be disseminated through publication in an academic journal and scientific conferences. PROSPERO registration number CRD42018097142.

    Kayode Philip Fadahunsi, James Tosin Akinlua, Siobhan O’Connor, Petra A. Wark, Joseph Gallagher, Christopher Carroll, Azeem Majeed, John O’Donoghue·2019·BMJ Open
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  • The NUDGE trial pragmatic trial to enhance cardiovascular medication adherence: study protocol for a randomized controlled trial

    Nearly half of patients do not take their cardiovascular medications as prescribed, resulting in increased morbidity, mortality, and healthcare costs. Mobile and digital technologies for health promotion and disease self-management offer an opportunity to adapt behavioral “nudges” using ubiquitous mobile phone technology to facilitate medication adherence. The Nudge pragmatic clinical trial uses population-level pharmacy data to deliver nudges via mobile phone text messaging and an artificial intelligent interactive chat bot with the goal of improving medication adherence and patient outcomes in three integrated healthcare delivery systems.

    Russell E. Glasgow, Christopher E. Knoepke, David Magid, Gary K. Grunwald, Thomas J. Glorioso, Joy Waughtal, Joel C. Marrs, Sheana Bull, P. Michael Ho·2021·Trials
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  • Text messages to increase attendance to follow-up cervical cancer screening appointments among HPV-positive Tanzanian women (Connected2Care): study protocol for a randomised controlled trial

    BACKGROUND: Cervical cancer is a major health concern in Tanzania, caused by poor attendance for cervical cancer screening and follow-up of women at risk. Mobile telephone health interventions are proven effective tools to improve health behaviour in African countries. So far, no knowledge exists on how such interventions may perform in relation to cervical cancer screening in low-income settings. This study aims to assess the degree to which a Short Message Service (SMS) intervention can increase attendance at appointments among women who have tested positive for high-risk (HR) Human Papillomavirus (HPV) during cervical cancer screening. METHODS/DESIGN: Connected2Care is a non-blinded, multicentre, parallel-group, randomised controlled trial. Tanzanian women testing positive to HR HPV at inclusion are randomly assigned in an allocation ratio of 1:1 to the SMS intervention or the control group (standard care). In a period of 10 months, the intervention group will receive 15 one-directional health educative text messages and SMS reminders for their appointment. The total sample size will be 700 with 350 women in each study arm. Primary outcome is attendance rate for follow-up. Secondary objectives are cost-effectiveness, measured through incremental ratios, and knowledge of cervical cancer by a 16-item true/false scale questionnaire at baseline and follow-up. Barriers against implementing the intervention will be assessed in a mixed-methods sub-population study. DISCUSSION: This study may provide information on the potential effects, costs, and barriers in implementing an SMS intervention targeting a group of women who are followed up after testing positive for HR HPV and are, therefore, at increased risk of developing cervical cancer. This can guide decision-makers on the effective use of mobile technology in a low-income setting. Trial status: recruiting. TRIAL REGISTRATION: ClinicalTrials.gov, ID: NCT02509702 . Registered on 15 June 2015.

    Ditte S. Linde, Marianne S. Andersen, Julius D. Mwaiselage, Rachel Manongi, Susanne K. Kjaer, Vibeke Rasch·2017·Trials
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  • Online platform for healthy weight loss in adults with overweight and obesity - the “POEmaS” project: a randomized controlled trial

    Background: Obesity is a major health problem in Brazil affecting 19% of Brazilian adults with a rising incidence over the last 10 years. Moreover, low fruit/vegetables consumption and high sweetened beverage intake are major issues. Facing the challenge of universal healthcare access, internet-based programs have the potential to reach a large number of inhabitants, be widely accessible and cost effective. Our aim is to to assess the efficacy of a webbased platform to promote weight loss and diet and physical activity habits change in a Brazilian adult population. Methods: We designed a three-arm parallel randomized controlled trial including 18–60 years university students or employees with 25 kg/m2 minimum body mass index (BMI). Pregnancy, conditions with specific dietary requirements and participation in other weight loss programs are exclusion criteria. Participants are allocated to one of three groups: (1) waitlist with minimal intervention, (2) web-based platform, (3) web-based platform plus online dietician assistance. Assessors are blinded. Weight and BMI loss are the primary outcomes. Diet and physical activity behaviours, health perception and online activity features are secondary outcomes. The intervention comprises recommendations of diet and physical activity habits tailored to the Brazilian population and principles of behaviour change. The web-based platform has online social network and gamification features. Analysis will be on an intention-to-treat basis at 12 and 24 weeks after baseline. Differences in weight loss between groups will be performed by analysis of covariate. Linear regression will be used to assess whether treatment group allocation is an independent predictor of weight loss. The study was approved by the Federal University of Minas Gerais (UFMG) Ethics Research Committee. All participants signed an informed consent form prior to recruitment. Discussion: We present the study protocol of a three arm parallel randomized controlled trial which aims to test the efficacy of an online platform to promote weight loss for adults with overweight and obesity. We anticipate that the adoption of healthy lifestyle habits and weight loss will be more important in participants randomized to the online platform group. Trial registration: NCT03435445 on February 16th, 2018.

    Alline Maria Beleigoli, Andre Queiroz De Andrade, Maria De Fátima Haueisen Diniz, Roberta Sonia Alvares, Antonio Luiz Ribeiro·2018·BMC Public Health
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  • Real-Time Triage, Position, and Documentation (TriPoD) During Medical Response to Major Incidents: Protocol for an Action Research Study

    Background: There is a need to address the implementation of technological innovation into emergency medical services to facilitate and improve information exchange between prehospital emergency care providers, command centers, and hospitals during major incidents to enable better allocation of resources and minimize loss of life. At present, there is a lack of technology supporting real-time information sharing in managing major incidents to optimize the use of resources available. Objective: The aim of this protocol is to develop, design, and evaluate information technology innovations for use in medical response to major incidents. Methods: This study has a qualitative action research design. This research approach is suitable for developing and changing practice in health care settings since it is cyclical in nature and involves development, evaluation, redevelopment, and replanning. The qualitative data collection will include workshops, structured meetings, semistructured interviews, questionnaires, observations, and focus group interviews. This study assesses the use of a digital solution for real-time information sharing by involving 3 groups of indented users: prehospital emergency care personnel, hospital personnel, and designated duty officers with experience and specific knowledge in managing major incidents. This study will explore end users’ experiences and needs, and a digital solution for prehospital and hospital settings will be developed in collaboration with technology producers. Results: The trial implementation and evaluation phase for this study is from April 2024 to May 2026. Interviews and questionnaires with end users were conducted during the planning phase. We have performed observations in connection with 2 major exercises in April 2024 and November 2024. The outcome of this analysis will form the basis for the design and development of a new information technology system. We aim to complete the observations in training sessions and exercises (phase 3) by September 2025, followed by modification of the technology solutions tested (phase 4) before dissemination in a scientific journal. Conclusions: This protocol includes several methods for data collection that will form the basis for the design and development process of a digital solution for real-time information sharing to support efficient management in major incidents based on the experiences and requirements of end users. The findings from this study will contribute to the limited research on users’ perspectives and the development of digital solutions for real-time information during major incidents.

    Monica Rådestad, Torkel Kanfjäll, Veronica Lindström·2024·JMIR Research Protocols
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  • Korea Nurses’ Health Study and the health of reproductive-aged women: a cohort profile

    Korea Nurses’ Health Study and the health of reproductive-aged women: a cohort profile

    Chiyoung Cha, Heeja Jung, Sue Kim, Jung Eun Lee, Kwang-Pil Ko, Eunyoung Cho, Hyun-Young Park, Joong-Yeon Lim, Bo Mi Song, Sihan Song, Soojin Park, Aram Cho·2024·Epidemiology and Health
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  • Examining the impact of a symptom assessment application on patient-physician interaction among self-referred walk-in patients in the emergency department (AKUSYM): study protocol for a multi-center, randomized controlled, parallel-group superiority trial

    Due to the increasing use of online health information, symptom checkers have been developed to provide an individualized assessment of health complaints and provide potential diagnoses and an urgency estimation. It is assumed that they support patient empowerment and have a positive impact on patient-physician interaction and satisfaction with care. Particularly in the emergency department (ED), symptom checkers could be integrated to bridge waiting times in the ED, and patients as well as physicians could take advantage of potential positive effects. Our study therefore aims to assess the impact of symptom assessment application (SAA) usage compared to no SAA usage on the patient-physician interaction in self-referred walk-in patients in the ED population.

    Hendrik Napierala, Marvin Kopka, Maria B. Altendorf, Myrto Bolanaki, Konrad Schmidt, Sophie K. Piper, Christoph Heintze, Martin Möckel, Felix Balzer, Anna Slagman, Malte L. Schmieding·2022·Trials
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  • Risk factors, symptom reporting, healthcare-seeking behaviour and adherence to public health guidance: protocol for Virus Watch, a prospective community cohort study

    Introduction The coronavirus (COVID-19) pandemic has caused significant global mortality and impacted lives around the world. Virus Watch aims to provide evidence on which public health approaches are most likely to be effective in reducing transmission and impact of the virus, and will investigate community incidence, symptom profiles and transmission of COVID-19 in relation to population movement and behaviours. Methods and analysis Virus Watch is a household community cohort study of acute respiratory infections in England and Wales and will run from June 2020 to August 2021. The study aims to recruit 50 000 people, including 12 500 from minority ethnic backgrounds, for an online survey cohort and monthly antibody testing using home fingerprick test kits. Nested within this larger study will be a subcohort of 10 000 individuals, including 3000 people from minority ethnic backgrounds. This cohort of 10 000 people will have full blood serology taken between October 2020 and January 2021 and repeat serology between May 2021 and August 2021. Participants will also post self-administered nasal swabs for PCR assays of SARS-CoV-2 and will follow one of three different PCR testing schedules based on symptoms. Ethics and dissemination This study has been approved by the Hampstead National Health Service (NHS) Health Research Authority Ethics Committee (ethics approval number 20/HRA/2320). We are monitoring participant queries and using these to refine methodology where necessary, and are providing summaries and policy briefings of our preliminary findings to inform public health action by working through our partnerships with our study advisory group, Public Health England, NHS and government scientific advisory panels.

    Andrew Hayward, Ellen Fragaszy, Jana Kovar, Vincent Nguyen, Sarah Beale, Thomas Byrne, Anna Aryee, Pia Hardelid, Linda Wijlaars, Wing Lam Erica Fong, Cyril Geismar, Parth Patel, Madhumita Shrotri, Annalan M. D. Navaratnam, Eleni Nastouli, Moira Spyer, Ben Killingley, Ingemar Cox, Vasileios Lampos, Rachel A. McKendry, Yunzhe Liu, Tao Cheng, Anne M. Johnson, Susan Michie, Jo Gibbs, Richard Gilson, Alison Rodger, Robert W. Aldridge·2021·BMJ Open
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  • Testing the Effectiveness of an Intervention to Improve Romanian Teachers’ LGBT+-Related Attitudes, Cognitions, Behaviors, and Affect: Protocol for a Randomized Controlled Trial

    Background: Repeated stigmatization due to group membership constitutes a recurrent stressor with negative impact on physical and mental health (minority stress model). Among European countries, Romania ranks low on LGBT+ (lesbian, gay, bisexual, and transgender people. The “+” represents individuals whose identities do not fit typical binary notions of male and female [nonbinary]) inclusion, with 45% of Romanian LGBT+ respondents reporting discrimination in at least 1 area of life in the year preceding the survey. Importantly, while all LGBT+ people might experience minority stress, younger sexual minority individuals are more prone to the detrimental impacts of stigma on their mental and physical health. As such, interventions are necessary to improve the inclusion climate within schools, where young people spend most of their time. Until now, most interventions addressing this topic have been conducted on undergraduate students in Western countries, with no studies conducted in countries that have widespread anti-LGBT+ attitudes. Objective: This paper describes the research protocol for a randomized controlled trial investigating whether LGBT+ stigma and bias among Romanian school teachers can be reduced using an internet-based intervention focusing on education and contact as primary training elements. Methods: A sample of 175 school teachers will be randomly assigned to either the control or experimental group. The experimental group participants will receive the intervention first and then complete the outcome measures, whereas the control group will complete the outcome measures first and then receive the intervention. The 1-hour multimedia intervention is developed for internet-based delivery under controlled conditions. It includes 2 interactive exercises, 2 recorded presentations, animations, and testimonies from LGBT+ individuals. Data for attitudinal, behavioral, cognitive, and affective measures will be collected during the same session (before or after the intervention, depending on the condition). We also plan to conduct a brief mixed methods follow-up study at 6 to 8 months post participation to investigate potential long-term effects of training. However, due to attrition and lack of experimental control (all participants will have completed the intervention, regardless of the condition), these data will be analyzed and reported separately using a mixed methods approach. Results: This paper details the protocol for the teacher intervention study. Data collection began in December 2022 and was completed by February 2023. Data analysis will be performed upon protocol acceptance. Follow-up measures will be completed in 2024. Results are expected to be submitted for publication following analysis in the spring of 2024. Conclusions: The findings of this study will establish the effectiveness of an internet-based intervention intended to lessen anti-LGBT stigma and sentiment in a nation where these views have long been prevalent. If successful, the intervention could end up serving as a resource for Romanian teachers and guidance counselors in high schools. Trial Registration: ISRCTN 84290049; https://doi.org/10.1186/ISRCTN84290049

    Ioana Latu, Nastasia Sălăgean, Torill M. B. Larsen, Andreea Bogdana Isbasoiu, Florin Alin Sava·2024·JMIR Research Protocols
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