Gamification, or incorporating game-like elements into non-game settings to achieve specific objectives, is an emerging pedagogical tool in education. However, research of its effectiveness on learning is mixed. We draw on existing theory to develop and test a framework that explains the mechanisms through which gamification influences outcomes. Our findings demonstrate that adding a game-like element to an accounting activity can increase enjoyment in the activity, lead to greater cognitive engagement, deeper information processing, and improved learning. However, the increase in enjoyment was primarily driven by using avatars, whereas an interconnected challenge and peer collaboration statements did not produce similar effects. Our findings also reveal that, although enjoyment fosters various forms of engagement, it is cognitive engagement that has a positive and significant relationship with deeper information processing. Our study offers a practical guide for classroom gamification, along with suggested opportunities for further research to expand and refine it.Data Availability: Data are available upon request.

To examine the impact of women on boards (WOB) and of Japan's corporate governance (CG) code on earnings quality (EQ), we explore women's roles in enhancing EQ and their interactions with bank monitoring within a bank-based financial system. This report intends to reveal whether the role of WOB complements or substitutes for the monitoring of main banks to enhance EQ in Japan. Our study also focuses on Japan's dual audit system as a unique institutional setting. This report contributes to the discussion of whether the presence of WOB effectively enhances EQ in bank-based systems. This report will provide insight into the effectiveness of the CG code in promoting greater representation of WOB and contribute to “Who are effective monitors to enhance earnings quality”.

IntroductionDomestic violence (DV) is a significant public health problem linked to poor mental health outcomes. Prior research has relied on self-reported symptoms, overlooked mental disorders prevalent in men, inadequately controlled for confounders, and failed to differentiate between forms and severity of DV.MethodsThis registered report protocol outlines the rationale, design, and planned analyses for investigating the relationship between DV and mental disorders in both Norwegian men and women. We will use data from a population-representative psychiatric diagnostic interview survey linked to national health registries. Key confounders, including sociodemographic and health-related variables, will be adjusted for.ResultsWe will examine the association between DV and mental disorders in both men and women, assess cumulative effects of multiple forms of violence, and examine the temporal ordering of DV and mental disorders. Outcomes include anxiety, depression, PTSD, substance use disorder, and suicidality.DiscussionThis study offers population-based insights into the relationship between domestic violence and mental health across genders. The findings may help guide targeted interventions and inform public health policy, particularly in high-income settings.

Stage 1 IPA at PCI RR

Stage 1 IPA at PCI RR

Background In the early years of schooling, learning tends to resolve information gaps and decrease ambiguity, and within this structure, high performing students learn to thrive and maximise performance. This changes irrevocably in doctoral education. The prototypical doctoral student is striving to investigate a research gap for which there is currently no answer in the entire body of literature, requiring a leap into the unknown with no guarantee of understanding. Prior learning expertise cannot necessarily be trusted, and this vastly heightened uncertainty may impact students' interest in their studies, plans for a research-focused career, and doctoral completion intentions over time. To date, however, no prior study has investigated how perceptions of uncertainty in learning may longitudinally relate to these factors, nor how individual differences such as one's openness to experience might provide a buffer against any negative effects. Method This Stage 1 registered report presents plans for a 10-month longitudinal assessment of 400 doctoral students. At monthly intervals, students will report their instances of uncertainty in learning, completion intentions, outcome expectations, interest, productivity, and wellbeing. Results will be analysed with dynamic structural equation models, predicting key outcomes from perceptions of uncertainty in learning at the previous time point, with personality traits openness to experience and neuroticism as potential moderators. Results and discussion will be presented in the Stage 2 Registered Report.

Stage 1 IPA at PCI RR

Background Intensive care unit-acquired weakness (ICUAW) and post-intensive care syndrome (PICS) are significant complications among critically ill patients, leading to prolonged hospital stays, increased healthcare costs, and reduced quality of life. Early physical therapy in the ICU has shown promise in mitigating these adverse outcomes, yet randomized controlled trials (RCTs) evaluating the combined effects of physical, respiratory, occupational, and speech therapy initiated within the first 24–72 hours are lacking. Methods This single center, controlled clinical trial aims to establish the efficacy and safety of an early multimodal rehabilitation program (MRP) compared with a late MRP in mechanically ventilated patients admitted to the ICU. Adult patients (≥18 years) with a Barthel score ≥70 and requiring invasive mechanical ventilation for more than 24 hours will be included. Participants will be randomly assigned to early MRP, initiated within 24 hours post-intubation, or late MRP, starting 72 hours post-intubation. The primary outcome is the duration of mechanical ventilation. Safety will be assessed by comparing the number of adverse events between groups. The MRP includes passive and active interventions from physical, speech, respiratory, and occupational therapy teams. Therapy intensity and type are adjusted according to the patient’s Richmond Agitation-Sedation Scale (RASS) score. Patients with lower RASS scores (indicating deeper sedation) will receive primarily passive interventions (e.g., passive range-of-motion exercises), while those with higher RASS scores (indicating lighter sedation or alertness) will engage in more active therapies (e.g., active-assisted exercises and functional mobility activities). For patients with RASS ≥2, occupational therapy will focus on behavioral and environmental modulation, employing calming techniques, sensory stimuli, and cognitive tasks, with family education to support spatiotemporal orientation. This adaptive approach ensures patient safety and optimizes therapy based on the patient’s current sedation level and clinical condition. Dissemination The results will be published in peer-reviewed journals and presented at conferences. Trial registration ClinicalTrials.gov NCT06133504. Registered on November 11, 2023.

Economic dishonesty is a widespread behavior that has substantial implications on organizations and societies. Recent studies suggest that decision making in groups or commitment to other individuals can further increase such dishonesty in contrast to individual decision making. Various interventions have been suggested to curb dishonesty and the most classical economic approaches emphasize the use of punishment by focusing on both the risk (“how likely am I to get caught?”) and the severity (“what fine will be imposed?”) of punishment, respectively. However, the effects of punishments on dishonesty are mixed and it is currently unclear if punishment can be effective in collaborative settings. Here, we suggest to provide a high-powered online study (N = 630) collecting UK-based Prolific participants in which we manipulate (1) the type of payoff (whether dishonesty earns money for the individual or for the group), (2) the risk of punishment (no risk or 30% audit chance), and (3) the type of punishment (whether the individual is punished or the whole group in case of getting caught). The study will shed light on the interplay between individual or group decision making and the specifics of punishment as well as advance the understanding under which conditions punishment might be effective in curbing dishonesty.

Grant peer review processes are pivotal in allocating substantial research funding, yet concerns about their reliability persist, primarily due to low inter-rater agreement. This study aims to examine factors associated with agreement among peer reviewers in grant evaluations, leveraging data from 134,991 reviews across four Norwegian research funders. Using a cross-classified linear regression model, we will explore the relationship between inter-rater agreement and multiple factors, including reviewer similarity, experience, expertise, research area, application characteristics, review depth, and temporal trends. Our findings are expected to shed light on whether similarity between reviewers (gender, age), their experience, or expertise correlates with higher agreement. Additionally, we investigate whether characteristics of the applications—such as funding amount, research area, or variability in project size—affect agreement levels. By analyzing applications from diverse disciplines and funding schemes, this study aims to provide a comprehensive understanding of the drivers of inter-rater agreement and their implications for grant peer review reliability. The results will inform improvements to peer review processes, enhancing the fairness and validity of funding decisions. All data and analysis scripts will be publicly available, ensuring transparency and reproducibility.

The present pre-registered report explores the potential of AI-driven contact interventions by integrating generative Artificial Intelligence-based artificial humans into E-contact paradigms. Grounded in Allport's (1954) Contact Hypothesis and the Dual Identity Model (DIM; Gaertner & Dovidio, 2000), the study examines whether structured interactions with artificial humans can foster positive intergroup attitudes. Following the framework of E-contact interventions (White & Abu-Rayya, 2012), participants (N = 70 Caucasian university students) will engage in a within-between mixed-design experiment over three days. They will interact daily with an AI-powered 3D digital assistant representing either an outgroup member (Black avatar) or an ingroup member (White avatar) depending on the experimental condition, with pre- and post-intervention measures of intergroup attitudes. The structured interactions will follow the two-phase design of E-contact interventions, initially fostering personal acquaintance, then emphasizing group salience, and finally reinforcing a shared superordinate identity—a process aligned with the principles of DIM to maximize the generalization of positive intergroup attitudes. The virtual assistant will facilitate cooperative activities designed to enhance inclusivity, promote cultural exchange, and maintain subgroup distinctiveness while fostering a common identity. To ensure the effectiveness and coherence of the intervention, the scripted interactions will be pretested through a pilot study before implementation. This research offers a preliminary step toward understanding how artificial intelligence might contribute to enhancing E-contact interventions, potentially providing scalable and structured tools for fostering positive intergroup relations and supporting social integration.

The proposed studies will test two competing hypotheses and one additional hypothesis. The first hypothesis is that reliance on ethnic or race stereotypes in implicit person perception is more malleable than reliance on gender stereotypes in implicit person perception in response to counterstereotypic individuating information. The competing hypothesis is that reliance on ethnic or race and gender stereotypes in implicit person perception are equally malleable in response to such information. An additional hypothesis is that reliance on weaker stereotypes in implicit person perception is more malleable than reliance on stronger stereotypes in response to counterstereotypic individuating information. Studies 1 and 2 will test the competing hypotheses using the same stereotyped attributes as they apply to both gender and racial or ethnic groups to maximize experimental control and will utilize race or ethnic stereotypes that are stronger than gender stereotypes, unlike previous research. Study 3 will fully cross the strength of the stereotype with the type of stereotyped group (gender vs. ethnic) to test the stereotype strength hypothesis and thus rule out alternative explanations for the results. To maximize generalizability, Study 4 will comprise an aggregation of 14 studies that are capable of testing the competing hypotheses: Studies 1–3 in the present research, and 11 previous studies that used the present research design. Regardless of which hypotheses are supported, the present research will contribute to a growing body of knowledge about the circumstances under which implicit associations prevail vs. can be shifted by valid, relevant information in the social environment.

Introduction Up to 50% of adult patients with epilepsy experience comorbid depression or anxiety, complicating post-treatment recovery and requiring tailored outcome assessment. No core outcome set (COS) exists for this dual-diagnosis population, unlike broader epilepsy COSs or quality-of-life COSs for drug-resistant epilepsy, which do not prioritize mental health comorbidities. This protocol outlines the development of a standardized COS to evaluate post-treatment recovery in adults with epilepsy and comorbid depression or anxiety, using the International Classification of Functioning, Disability, and Health (ICF) framework to ensure a biopsychosocial perspective. This COS aims to enhance cross-study comparability and inform personalized care for this underserved group. Methods and analysis This study will employ a three-phase process: (1) A systematic review of outcomes in epilepsy with comorbid depression or anxiety in adult patients, searching PubMed, Embase, and Cochrane Library per Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, including outcomes such as seizure control, mood stability, cognitive function, social reintegration, and suicide-related outcomes; (2) Mapping outcomes to ICF domains (body functions, activities, participation) for comprehensive coverage; and (3) A three-round Delphi survey using a 9-point Likert scale to achieve consensus among an international panel of ≥60 stakeholders, including neurologists, psychiatrists, psychologists, patients, and caregivers, with ≥20% from low- and middle-income countries. Consensus requires ≥70% agreement on scores of 7–9 (critically important) and ≤15% on 1–3 (low importance). The COS will capture domains like seizure control, mood stability, cognitive function, and social reintegration. Discussion This COS will address a critical gap by standardizing outcome measurement for adults with epilepsy and mental health comorbidities, complementing broader COSs, such as the Epilepsy Outcome Set for Effectiveness Trials (EPSET), by focusing on mental health recovery, including suicide-related outcomes, and extending quality-of-life-focused sets, such as those using the Quality of Life in Epilepsy (QOLIE) scales, to include neurological and functional outcomes. The ICF-guided, patient-inclusive approach ensures global relevance. Potential limitations, including stakeholder bias, will be mitigated through diverse recruitment and robust consensus methods. Conclusion This protocol leverages Delphi methodology and ICF principles to develop a novel COS for a complex dual-diagnosis population. By prioritizing mental health recovery in adults, including critical outcomes like suicide prevention, it offers a distinct tool to enhance research and clinical practice, with future validation planned to ensure applicability across settings. PROSPERO registration number CRD42024576141

Background Teachers are encouraged to consider relevant evidence from educational research to improve the quality of their instruction. This approach requires them to have a reasonably accurate idea of the effectiveness of educational interventions. Currently prevalent ways of communicating effect sizes, however, often lead to imprecise effect magnitude estimates. Aims We aim to investigate how teachers estimate and perceive verbally and visually communicated effect sizes. Sample For the pilot study, N = 20 English-speaking teachers were recruited on Prolific, and for the main study, N = 120 will be recruited. Planned methods We employ a randomized 4 × 6 × 2 between–within-within-person experiment with the outcomes of interest being teachers' effect magnitude estimates and perceived relevance, informativeness, and difficulty. Pilot results Across the conditions, teachers' effect magnitude estimates correlated strongly (τ = 0.69) with true effect sizes and personified relevance correlated moderately (τ = 0.41) with objective relevance. However, teachers were less accurate in the verbal than in the visual condition (Cohen's d = −0.52, 95 % CI = [−0.81, −0.23]). Conversely, they perceived verbally communicated Cohen's U3 expressions as more informative (rrb = −0.27, 95 % CI = [−0.40, −0.13]), and less difficult (rrb = 0.31, 95 % CI = [0.17, 0.44]) to understand than visually communicated effect sizes. Preliminary conclusion Communicating effect sizes can work verbally and visually.

Stage 1 IPA at PCI RR

This study investigates the effects of Animal-Assisted Treatments (AATx) on brain signal complexity in patients in a minimally conscious state (MCS), focusing on entropy measures derived from EEG signals. Using a cross-over randomized controlled trial, 26 patients will undergo four sessions, alternating between AATx and standard occupational therapy (SOT). EEG measures will include Sample Entropy, Lempel-Ziv Complexity, and Symbolic Transfer Entropy, capturing different dimensions of brain signal complexity. Higher values of complexity are expected when and after AATx sessions compared to SOT sessions. As secondary measures heart rate, heart rate variability, and electrodermal activity will be recorded together a behavioral measure of consciousness. Higher values of secondary measures are expected when and after AATx sessions compared to SOT sessions. The study aims to evaluate the potential effects of AATx on brain entropy of MCS patients in early neurorehabilitation.

Functional connectivity is frequently used to assess dynamic brain functioning and predict individual differences in behavioral outcomes, such as psychopathology. Inferences from functional connectivity analyses typically rely on group-averaged model statistics. However, heterogeneity between individuals may lead to group-level models that poorly reflect each individual. Poor individual-level precision may limit the ability to make individual-level predictions, which is necessary for key goals such as clinical translation. This registered report examined between-person heterogeneity in resting-state functional connectivity strength patterns by assessing similarity between group- and individual-level connectivity models in the Adolescent Brain Cognitive Development study. Using intraclass correlation coefficients, we found that a group-averaged region-of-interest-based connectivity model was a poor reflection of every individual. In contrast, a group-averaged model of between- and within-network connectivity was a good representation of most individuals. We then examined how individual-level distinctness from the group moderated predictive performance of several clinical and neurocognitive scales. Hypotheses that group-to-individual dissimilarity would worsen behavioral prediction were not supported with primary clinical outcomes. The little psychopathology reported in this sample was a notable limitation. In contrast, lower similarity to the group worsened prediction of performance on the pattern comparison test, providing minor support for hypotheses. Overall, results suggest that region-of-interest-based functional connectivity networks are highly heterogeneous and group-based models are inappropriate for individual-level inferences, but that network-based connectivity is largely similar across individuals. Additionally, we provide minor evidence of the impacts of heterogeneity on prediction that future studies should build on.

This paper presents the Stage 1 protocol for a confirmatory study investigating how biometric measurements can reveal cognitive differences in software development with and without AI assistance. We outline the theoretical foundation, specific hypotheses, detailed methodology, and planned analyses that will be conducted to address our research questions. Our study aims to identify and understand the neurophysiological correlates of the cognitive processes involved in AI-assisted programming and how these relate to measurable performance outcomes and developer perceptions.

Despite the abundant evidence for the general decline in interest during the time spent at school, less is known about the implications of school transition for these declining trajectories of interest. While both Basic Psychological Needs Theory and Stage-environment Fit Theory suggest that students’ interest declines after school transition, they do not clearly predict the nature of the decline. However, there are two possible ways in which interest decreases as a function of school transition: a discontinuous drop during the transition (the immediate impact hypothesis) and a steeper decline during secondary school (the long-term impact hypothesis). Using four years of annual longitudinal data from Japanese students from the fifth grade to the ninth grade, the present study will investigate the developmental trajectory of students’ interest during the period that includes school transition. The impact of SES and gender on the developmental trajectories of interest during the period that includes school transition will also be examined.

The pain- and stress-reducing effects of music are well-known, but the effects of visual art, and the combination of these two, are much less investigated. We aim to (1) investigate the pain- and (2) stress-reducing effects of multimodal (music + visual art) aesthetic experience as we expect this to have stronger effects than a single modal aesthetic experience (music/ visual art), and in an exploratory manner, (3) investigate the underlying mechanisms of aesthetic experience, and the (4) individual differences. In a repeated-measures design (music, visual art, multimodal aesthetic experience, control) participants bring self-selected “movingly beautiful” visual artworks and pieces of music to the lab, where pain and stress are induced by the cold pressor test. Activity of the pain and stress responsive systems are measured by subjective reports, autonomic (electrocardiography, electrodermal activity, salivary alpha-amylase) and endocrine markers (salivary cortisol).

Hosted on the Open Science Framework

Do people experience emotions in the same way? How can we characterize the sameness of emotional quality? Qualitative aspects of emotional experience are usually communicated through words. However, words can be ambiguous and can mean different things to different people. Here, we introduce a relational approach that characterizes emotional experiences as structure based on similarity judgments among emotion-evoking videos. This registered report will apply this method to characterize a psychological condition of “alexithymia”, which is described as “no words for emotions”. Do people with alexithymia experience the same emotions with altered expressivity? Or do they not experience them to begin with? Our structural approach will determine if individuals with high and low alexithymia have the same emotional experiences. Our findings will open the door to the study of emotional experiences by offering a relational approach that bypasses verbal reports and will help to clarify the nature of alexithymia.

Stage 1 IPA at PCI RR

Researchers and policy-makers have widely hypothesized that psychological distance to climate change acts as a barrier to climate action, and that reducing this psychological distance is a promising strategy to promote it. However, over the last decade, correlational and experimental studies have highlighted complex and inconsistent results, raising doubts about the effects of reduced psychological distance to climate change on policy support and intention to perform climate-related behaviours. To address this issue, this research adopts a meta-analytical approach (i) to evaluate the size of the effect of psychological distance to climate change on climate action, and (ii) to investigate some factors that might explain the heterogeneity of these effects.

Presented by OSF

This project contains the manuscript and raw preliminary data for the stage 1 registered report "Cognitive, affective and behavioural effects of temporal comparison with prior aversive experiences in individuals with social anxiety" Hosted on the Open Science Framework

Presented by OSF

In hundreds of articles published over the past two decades, nanoparticles have been described as probes for sensing and imaging of a variety of intracellular cytosolic targets. However, nanoparticles generally enter cells by endocytosis with only a small fraction reaching the cytosol. Most of those articles do not describe the mechanisms of nanoparticles entry into the cell and therefore the paradox of sensing a target in the cytosol when most particles do not access that compartment remains. To address this paradox, we are initiating a replication project of some of the most influential articles in this field with the aim of confirming their ability to detect their targets and getting additional insights into their intracellular localisation. This article is a pre-registered report for the second replication of this project, namely the replication of Seferos et al ‘Nano-Flares: Probes for Transfection and mRNA Detection in Living Cells’. To achieve our aim, we will carry out both a direct replication of the experiments in the original article, with the addition of some experiments and controls (in particular optical and electron microscopy). We hope that this study will contribute to a better understanding of the intracellular fate of nanoparticles and, with the help of the scientific community, help set standards in the design and reporting of studies in this field.

Presented by OSF

Presented by OSF

Presented by OSF

Presented by OSF

Presented by OSF

We present a programmatic research line to test whether a longitudinal intervention aiming to increase key psychological correlates of pro-environmental behavior motivates young adults to take climate action. In five longitudinal studies, we will test and optimize a six-week, in-person intervention, exposing participants to interactive lessons and activities that were developed from existing psychological theories and interventions. The goal is to increase pro-climate behavior by leveraging 12 psychological correlates such as beliefs, attitudes and affect. Before and after the intervention, participants will complete surveys measuring the psychological correlates, and also report individual and collective pro-climate behaviors via Ecological Momentary Assessment (EMA). Each study will include a control group. The psychological correlates and behavior will be measured again after three months to assess the medium-term effectiveness of the intervention. The results and participant feedback from each study will be used to update the intervention for the following studies. Each study will target young adults at different life stages (studying or working) across two countries (Italy and the Netherlands). The longitudinal design, the intensive manipulations and EMA’s ecological validity are uniquely capable of revealing causal evidence that changes in beliefs, attitudes and affect lead to climate action across age groups and cultures. Hosted on the Open Science Framework

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Background: Patients with long-term health needs are often expected to actively participate in outpatient care, assuming that they have appropriate health literacy and digital health literacy. However, the association between participation in a digital outpatient service and health literacy remain unclear.

Background: Admission to a hospital can be a very stressful and anxiety-provoking experience, as patients face many unknowns that can compromise their physical and psychological well-being. Patient-centered care necessitates that health care organizations and professionals actively comprehend patients’ experiences and values, for which effective training in communication skills is essential. Objective: This study will contribute to this field of research by evaluating a blended therapeutic communication training program. Methods: The training consists of online e-learning that provides insights into important concepts of therapeutic communication, followed by a virtual reality patient-embodied experience shown to help nurses feel what it is like to be a patient themselves during a 1-day didactic training with experiential small groups. Theory on therapeutic communication is taught, focusing on how to use rapid rapport techniques and hypnotic and suggestive language to facilitate empathy. This is combined with practical exercises, ensuring an active learning process. By integrating these diverse blended learning training methods, the program aims to enhance nurses’ communication skills, ultimately improving patient care. Applying the Kirkpatrick model for training evaluation, this prospective study will use a convergent mixed methods study design, integrating both qualitative and quantitative data. Qualitative data will include fieldwork, as well as individual and focus group interviews with the participating nurses. Quantitative data will include questionnaires that include the first two levels of the Kirkpatrick model and that are validated for this purpose. Inclusion started in April 2024, and the therapeutic communication training was scheduled for the first half of 2024. Results: On February 8, 2024, we received permission from the authorizing body (Institutional Science Committee and NWMO Committee) to start our study. Data collection started in April 2024 and was completed by the end of 2024. Conclusions: This study will systematically evaluate the effectiveness of therapeutic communication training in the acute admission ward for patients who require emergency treatment. The results will yield insights into the feasibility and acceptance of the implementation of therapeutic communication training among nurses in an acute admission ward in the Netherlands.

Background: Interstitial lung diseases (ILDs), a group of parenchymal lung disorders, present with varying degrees of inflammation and fibrosis, which lead to symptoms such as progressive breathlessness, impaired quality of life (QoL), and reduced life expectancy. Patients with ILD can experience a sudden worsening of their condition, known as an acute exacerbation, which is associated with inappropriate hospital admissions, concomitant National Health Service (NHS) costs, impaired QoL, and high mortality. The heterogeneity of ILDs, the unpredictability of acute exacerbations, and significant variation in disease progression and response to treatment present numerous management challenges. Standard care typically involves 3-6 monthly hospital outpatient visits to monitor disease and assess response to treatment. Home monitoring with remote review of spirometry, pulse oximetry, and patient-reported measures offers an alternative approach to in-person clinic review and laboratory-based physiological measurements. Clinical trials indicate home monitoring of patients with ILD is acceptable, and results correlate with laboratory-based pulmonary function tests (PFTs). The impact of implementing home monitoring for patients with ILD in a real-world setting is not well understood. Objective: We aim to evaluate the safety, effectiveness, and acceptability of home monitoring with standard care in the management of patients with ILD. Methods: This study has been registered as a quality improvement project at Guy’s and St Thomas’ NHS Foundation Trust (reference 13660) and Royal Devon University Healthcare NHS Foundation Trust (reference 24-1378). The project has been co-designed by the steering group, including clinicians, researchers, technology partners, a patient advocacy charity, and patients diagnosed with ILD. Patients who meet the inclusion criteria will be provided a handheld spirometer, pulse oximeter, and access to patientMpower, an electronic health app, on their smart devices and followed up for 12 months. All participants will be asked to complete at least once weekly home spirometry and pulse oximetry measurements and 3 monthly patient-reported measures, including outcome, engagement, and experience measures, using the patientMpower app. Results will be available to the clinicians in real time and used to monitor disease progression, symptoms, and QoL, and to assess treatment response. Results: This study was funded by NHS Digital in September 2021. Patient recruitment and data collection started in March 2022. By January 2024, 186 patients were enrolled. All patients will have home monitoring for at least 12 months. Results are expected to be published at the end of 2025. Conclusions: We hypothesize home monitoring will be safe, effective and acceptable for patients with ILD and result in a 50% reduction in routine laboratory-based pulmonary function tests and in-person clinic consultations.

Background: Venous thromboembolism (VTE) is a significant public health issue, with a rising global incidence despite extensive research efforts. Patient-centered care, which tailors treatment to individual needs, has shown potential in enhancing outcomes. The integration of smart technologies with psychological frameworks such as the health belief model and the knowledge-attitude-practice (KAP) model may further improve patient engagement and adherence. To address this, we have developed a smart technique–assisted patient-centered care mobile health app for managing VTE (mVTEA), which integrates psychological frameworks to improve patient outcomes in VTE management. Objective: This study aims to investigate the impact of the mVTEA app on the knowledge, attitudes, and practices of VTE in patients with or at high risk of VTE. Methods: The SmaVTE (smart technology facilitated patient-centered venous thromboembolism management) study is a 2-armed, single-center, parallel-group, randomized controlled trial. A total of 256 hospitalized patients with or at high risk of VTE will be recruited on the day of their discharge from August 2024 to June 2025. Participants will be randomly allocated to either the mVTEA management group or the routine management group in a 1:1 ratio. The mVTEA management group (n=128) will receive patient-centered VTE management facilitated by the mVTEA app after discharge. The routine management group (n=128) will be administered conventional postdischarge management according to local clinical practice. The KAP of patients will be assessed by a structured KAP questionnaire on VTE. The primary outcome is the difference in patients’ KAP on VTE at 3-month follow-up between the 2 groups. Secondary outcomes include scores on each domain of the questionnaire, quality of life, VTE events, chronic thromboembolic pulmonary hypertension, chronic thromboembolic pulmonary disease, postpulmonary embolism syndrome, major bleeding events, VTE-related hospitalizations or rehospitalizations, deaths, and new-onset atrial fibrillation or atrial flutter at 3-month follow-up. Results: Participants are currently being recruited. The first participant was enrolled in August 2024, which marked the official start of the study. The recruitment process is expected to be completed in June 2025. As of the submission of the paper, 185 patients had been enrolled in this clinical trial. At present, all included patients are being followed up according to the outlined schedule. Conclusions: The SmaVTE study offers a pioneering approach to VTE prevention and treatment by combining smart technology with patient-centered care and established theoretical frameworks. The findings could significantly impact clinical practice and inspire further research into the integration of smart technologies with behavioral science theories. Trial Registration: ClinicalTrials.gov NCT06350331; https://clinicaltrials.gov/study/NCT06350331

Background: Atrial fibrillation (AF) after radiotherapy (RT) in patients with breast cancer (BC) is a relatively new and understudied topic. AF can increase the risk of stroke and other serious cardiovascular complications, compromising patients’ quality of life and survival. Screening of AF, both asymptomatic and symptomatic forms, is therefore essential for optimal management. Objective: The aim of the Watch Your Heart After Radiotherapy for Breast Cancer (WATCH) study is to assess the incidence of AF (symptomatic or asymptomatic) occurring throughout a 5-year follow-up after RT and to investigate whether cardiac radiation exposure is associated with the occurrence of such events. Methods: WATCH is a cohort study that will include 200 patients over 65 years old, treated with RT for BC 5 years before inclusion and without a history of AF. Cross-sectional screening for AF at the time of the scheduled 5-year post-RT visit will be conducted by recording data from a Withings ScanWatch smartwatch for 1 month, confirmed by an electrocardiogram (ECG), and validated by a physician. In addition, a transthoracic echocardiography (TTE) will be performed, providing a comprehensive assessment of cardiac structures, and allowing us to investigate the underlying etiology and assess the risk of complications. Patients’ medical records will provide retrospective information about the timing and risk factors for the occurrence of AF and other arrhythmias and cardiac diseases during the 5 years following RT. The development of deep learning algorithms for autosegmentation analysis of potentially critical substructures for the occurrence of AF, including cardiac chambers, the sinoatrial node, the atrioventricular node, coronary arteries, and pulmonary veins (PVs), will produce dosimetry linked to previous RT treatment for all contoured structures. Results: Enrollment started in October 2023 and will continue until mid-2026 to include 200 patients, which will ensure an 80% statistical power to detect a significant difference in AF incidence around 15% for the group of patients moderately exposed (75th percentile of the mean heart radiation dose). The results are expected by the end of 2026. Conclusions: This study will contribute to generating new knowledge on AF after RT for BC and help considering the inclusion of AF screening into routine clinical practice for these patients. Identifying the dose-risk associations would improve RT delivery protocols to limit the occurrence of different forms of AF and, if necessary, initiate appropriate treatment. Clinical Trial: ClinicalTrials.gov NCT06073509; clinicaltrials.gov/study/NCT06073509?id=NCT06073509&rank=1.

Background: The prevalence of dementia is increasing in Canada and in many countries internationally. People living with dementia are highly dependent on family and friend care partners, who may have little knowledge of the disorder. Web-based interventions in dementia have been shown to improve care partner mental health and reduce burden, but few have been widely implemented or rigorously studied. We developed a web- and email-based dementia education platform for care partners, iGeriCare, which includes 12 asynchronous, multimedia, e-learning lessons and email-based content to reinforce the learning. Objective: The primary objective of this pilot study is to evaluate the feasibility and care partner acceptance of the intervention, including study methods. Secondary objectives will examine the effectiveness of the educational resources on family care partners’ knowledge, self-efficacy, and sense of burden. Methods: This study is a 2-arm, pilot, feasibility, randomized controlled trial. A total of 125 family or friend care partners for a person living with dementia—who are residing in Canada, aged 16+ years, and comfortable using the internet and email—will be recruited using coinvestigator networks and Facebook digital marketing advertisements. Participants will be randomly assigned to either the intervention group (receiving the dementia web- and email-based educational intervention) or the control group (receiving an alternate topic e-learning lesson and emails) and will have 8 weeks to complete baseline surveys and the assigned e-learning. After 8 weeks, participants will have 2 weeks to complete poststudy surveys. This protocol will be repeated with a second cohort of 100 care partners recruited from a paid panel service based on learnings from initial feasibility results. Results: Initial recruitment began on September 6, 2022, and concluded on October 2, 2022. A total of 125 participants were randomly assigned to the intervention (n=61) or control (n=64) group. Data collection concluded in January 2023. Preliminary feasibility results showed a substantial number of participants who did not engage with the protocol as intended. A decision was made to recruit a second cohort of participants to address these protocol deviations. Secondary recruitment began on June 12, 2023, and concluded on June 27, 2023. A total of 100 participants were randomly assigned to the intervention (n=53) or control (n=47) group. Data collection concluded in September 2023. Further results will be published in peer-reviewed journals and presented at conferences. Conclusions: This study is investigating the feasibility, acceptability, and effectiveness of a web- and email-based dementia care partner educational intervention. The results of this study will contribute to the planning of a larger randomized controlled trial in the future, as well as the evaluation of innovative, cost-effective, and efficient dementia care partner resources that can complement traditional approaches. Trial Registration: ClinicalTrials.gov NCT05114187; https://clinicaltrials.gov/study/NCT05114187

Background: Autism spectrum disorder (ASD) is a complex, incurable condition requiring lifelong care, often placing significant psychological strain on parents and emerging as a public health concern. While various interventions exist to enhance the psychological health of parents, the role of digital health interventions (DHIs) in this context remains underexplored. Objective: This scoping review aims to systematically assess the availability of DHIs targeting the psychological health of parents of children with ASD and evaluate the effectiveness of these interventions in improving parental psychological health. Methods: The review will include English-language studies published from inception to June 25, 2024, focusing on DHIs aimed at improving the psychological health of parents of children with ASD. Eligible studies will involve parents of children with ASD less than the age of 18 years, across various settings, and assess psychological health outcomes. A comprehensive search will be conducted across six databases: (1) CINAHL, (2) Ovid EMBASE, (3) Ovid Global Health, (4) Ovid MEDLINE, (5) Ovid PsycINFO, and (6) Web of Science. Studies will be screened and selected based on predefined eligibility criteria. Data extraction will include publication details, study design, participants’ characteristics, intervention specifics, comparisons, psychological outcomes, and key findings. Results will be synthesized using descriptive statistics, charts, and narrative analysis. Results: The initial keyword-based search, completed in June 2024, identified 5825 records, which were subsequently screened and analyzed. Screening and evidence synthesis were finalized in winter 2024, and the completed scoping review was submitted in December 2024. Conclusions: This study will provide a comprehensive overview of commonly used DHIs for supporting the psychological health of parents of children with ASD and their effectiveness. The findings will help identify research gaps, inform future studies and funding priorities, and contribute to the development of practice guidelines to enhance parental psychological health.

Background: The aging population and increasing prevalence of natural teeth among older adults have escalated the demand for oral health care, especially in nursing settings. Impaired oral health in older individuals is closely linked to systemic conditions such as diabetes and cardiovascular diseases. The expert standard “promoting oral health in nursing” was developed in Germany to enhance the quality of oral care and address future challenges in geriatric nursing. It comprises a series of recommended interventions targeting oral health promotion in nursing care. However, significant barriers, including high patient-to-nurse ratios and staff shortages, often result in missed or rationed nursing care, limiting the feasibility and implementation of such interventions. Evaluating the acceptability of this standard is critical to its successful integration into routine nursing practice. Objective: We aim to assess the acceptability of the expert standard among nursing staff providing care for older individuals, identify factors influencing its adoption, and examine the relationship between nursing competence, care rationed or missed (CROM), and the standard’s acceptability. Methods: This quantitative cross-sectional study will collect data from nursing staff in 25 hospitals and long-term care facilities in North Rhine-Westphalia, Germany, using standardized survey instruments. Based on the template of the generic theoretical framework of acceptability, a questionnaire to measure the acceptability of interventions across 7 domains was created. Oral health knowledge will be assessed using the Oral Health Literacy Profile and competence in mouth care using the questionnaire developed by the DNQP (Deutsches Netzwerk für Qualitätsentwicklung in der Pflege [German network for Quality Development in Nursing]). Barriers to implementation will be evaluated according to the acute care nurses’ questionnaire on oral hygiene and CROM using the oral care–related question from the Basel Extent of Rationing of Nursing Care instrument. Statistical analyses consist of first calculating the mean acceptability with a 95% CI for each recommended intervention of the expert standard. Second, repeated measures ANOVA is used to examine mean differences in acceptability between these interventions. Third, linear regression analyses are used to test the impact of nursing competence on acceptability and lastly chi-square tests of independence are used to compare CROM with already published rates in German-speaking countries. Results: The results are anticipated to provide insights into the acceptability of the expert standard and its determinants, including nursing competence and perceived barriers. Data collection will commence in June 2025 and is expected to be completed by October 2025. Conclusions: This study evaluates the acceptability of the expert standard for oral health in nursing. The findings will support evidence-based strategies to enhance feasibility, reduce CROM prevalence, and improve oral health in older adults. By focusing on acceptability as a prerequisite for implementation, this study emphasizes the need to align interventions with the realities of nursing care to achieve effective outcomes.

Background: People with multiple sclerosis (MS) experience life challenges due to the nature of disease progression. Although an active lifestyle has been shown effective for symptom and relapse management, most people with MS lead a sedentary lifestyle and do not reach the recommended physical activity (PA) guidelines. Objective: This study aims to test the preliminary efficacy of a codeveloped, online self-management intervention based on the health action process approach (HAPA) adapted for people with MS to cultivate a physically active lifestyle. Methods: The 8-week intervention program was developed using community-based participatory research based on the HAPA. The program includes increasing awareness of incorporating PA in a daily routine, the benefits of physical activities for people with MS, developing motivation, utilizing social and environmental support, setting measurable goals and doable plans, and coping with barriers for long-term adoption of new behaviors. Community members with MS serve as peer coaches. We aimed to recruit 60 people with MS, randomizing them to an intervention group or a wait-list control group. Control group participants do not receive any intervention nor information for the period of study. Participants will complete PA measures (accelerometer and survey) and psychological assessments at baseline; after an 8-week intervention; and 3 months, 6 months, and 12 months postintervention. We hypothesize that the intervention group will have (1) higher scores on the HAPA questionnaires and (2) higher frequency, duration, and intensity of engagement in PA after the intervention than the control group. We will conduct descriptive analyses (means, SDs), chi-squared tests, independent t tests, paired t tests, repeated measures ANOVA, and 2-way (any 2 factors of conditions, disability severity levels, and time) and 3-way (conditions × disability severity levels × time) mixed model ANOVAs. Results: The study was funded in April 2018 and was delayed due to the COVID-19 pandemic. We invited peer coaches to review the accessibility of online modules in fall 2022. We finalized the module accessibility and trained peer coaches on how to use the online modules in December 2022. Since February 2023, we have recruited 50 participants to the trial who have been assigned to the intervention group (n=25) or control group (n=25). During the follow-up stage, 3 participants dropped out of the intervention group, and 4 participants dropped out of the control group. Enrollment ended in 2024, and data collection is expected to conclude by December 2025, with results anticipated to be published in January 2026. Conclusions: This study will test the effectiveness of using an evidence-based online intervention for self-management of physical activity behavior by people with MS. The results of the study will provide us with insightful information for designing community-based participatory research and implementing telerehabilitation interventions for people with MS. Trial Registration: ClinicalTrials.gov NCT05124522; https://clinicaltrials.gov/study/NCT05124522

Background: A substantial proportion of patients require acute hospital care after hospital discharge post surgery, and many regions and countries have surgical backlogs. Objective: The Post Discharge After Surgery Virtual Care with Remote Automated Monitoring Technology-3 (PCV-RAM-3) trial tests the hypothesis that informing surgeons and patients of virtual care with remote automated monitoring (VC-RAM) assignment will promote earlier discharge, thereby reducing the index length of hospital stay, and that postdischarge VC-RAM will reduce acute hospital care. Methods: The PVC-RAM-3 trial is a randomized controlled trial that compares VC-RAM to standard postdischarge care among 2500 adults undergoing elective noncardiac surgery in 3 Canadian hospitals. Following the randomization of patients prior to surgery, surgeons and patients are immediately notified whether the patient has been allocated to the VC-RAM or control group. Outcome adjudicators remain blinded to each participant’s group assignment. Patients in the intervention arm learn to use a Health Canada–approved cellular modem–enabled tablet computer and Bluetooth-enabled remote automated monitoring technology from Cloud DX to take daily wound photos for 7 days and measure daily vital signs (ie, blood pressure, heart rate, oxygen saturation, temperature, and weight) three times daily on days 1-7 and twice daily on days 8-14 post discharge, along with completing a brief recovery survey. Nurses review these data and conduct scheduled virtual visits (days 1, 3, 7, and 14). Nurses will escalate care to a preassigned and available perioperative care physician if predetermined vital sign thresholds are exceeded, concerning symptoms arise, or a medication error is detected. These physicians manage the issues and add or modify treatments as needed. The standard care group will receive postdischarge care as per the standard of care at the hospital where they undergo surgery. The coprimary outcomes are acute hospital care and the index hospital length of stay within the first 30 days after randomization. Results: Study recruitment and follow-up are completed, and analysis of the study results is underway. Conclusions: This trial will offer insights into the role of VC-RAM in reducing acute hospital care and index length of hospital stay among adults undergoing elective surgery. Trial Registration: ClinicalTrials.gov NCT05171569; https://clinicaltrials.gov/ct2/show/NCT05171569

Background: The COVID-19 pandemic has had disproportionate economic and health impacts on self-employed workers in Nigeria, particularly self-employed women and youth. Though uniquely different, the COVID-19 pandemic shares similarities with events such as childbirth, family, and health emergencies. Self-employed young women lack adequate support structures to cope with disruptive life events, which have negative consequences for their well-being. This is concerning, as 86% of women in the Nigerian labor force are self-employed. Objective: The project’s first objective is to conduct a gendered situational analysis to address the question of how the COVID-19 pandemic and other life events affect the paid and unpaid work and the physical, mental, and social well-being of self-employed young women in Nigeria; their strategies for coping with such events; and how their experiences compare with those of self-employed young men. Informed by this analysis, the second objective is to coproduce and pilot-test a gender-transformative intervention that integrates social protection and promotes well-being. Methods: This multimethod project has 3 components. The first is a situational analysis of the impact of the pandemic and other significant life events on the work and well-being of self-employed young women vis-à-vis self-employed young men. This involves qualitative interviews with approximately 60 self-employed young women and men and a digital storytelling initiative to represent some of these stories in video format. Secondary data analysis of the Nigerian General Household Survey and the COVID-19 Longitudinal Phone Survey will be conducted. Furthermore, a scoping review of the impact of significant life events, including the COVID-19 pandemic, on self-employed workers in low- and middle-income countries will be conducted. The second component is the coproduction of interventions involving qualitative interviews with self-employed young women, members of their support network, and policy makers to find out their views on how to support self-employed women. It also entails an analysis of policies relevant to self-employed women in Nigeria and theory of change workshops to create a map for achieving the long-term goal of improving their resilience. Furthermore, a systematic review of interventions to improve the job quality and well-being of self-employed workers will be conducted. The third component is a pilot of the coproduced interventions in a quasi-experimental study involving 300 participants to assess feasibility, acceptability, cost, and potential effectiveness. Results: This project was funded in October 2022. Data collection for the project commenced in May 2023 and will end in November 2025. Data collection for the situational analysis and coproduction of intervention phases have been completed while the pilot of intervention packages is underway. Conclusions: This project will advance knowledge of the impact of the COVID-19 pandemic and other significant disruptive life events on the work and well-being of self-employed young Nigerian women and provide coproduced solutions to mitigate their effects.