1299 registered reports
Background: The global, nearly universal penetration of mobile phones has offered novel opportunities for delivering health services and communicating health-related information to individuals. A low-cost system that facilitates autonomous communication with individuals via mobile phones holds potential for expanding the reach of health messaging and service delivery in settings with human resource and infrastructure limitations. Objective: We sought to design a flexible, low-code system using open-source software that could be adapted to different contexts and technical environments and accommodate a wide range of automation needs. We report on key details of the mobile phone-based appointment reminder and incentive system (mParis), document its use, review implementation challenges and adaptations to address these challenges in the context of a quasi-randomized trial of mobile phone-based reminders and incentives as means of increasing the timeliness of routine childhood vaccinations in Tanzania, and outline other use cases that highlight the versatility of the system. Methods: The mParis instance described in this manuscript, which is hosted in Tanzania, sent automated, individualized vaccination reminders to the mobile phones of mothers of young children. Process workflows, based on the national childhood vaccination schedule of Tanzania, were programmed into mParis. Reminders for vaccinations due at ages 6, 10, and 14 weeks were sent 7 days and 1 day prior to and 14 days after each vaccination due date. A subset of messages included financial incentive offers to mothers for the timely vaccination of their children. We report on implementation outcomes, challenges, and adaptations to address these challenges. Results: Between August and December 2017, 412 pregnant women were enrolled into the trial. After mothers reported the birth of their children, individualized vaccination reminder messages were sent for vaccination due dates between January and July 2018. From March 2018, messages contained financial incentive offers. Of 1,397 messages sent, 1,122 SMS (80.3%) were recorded as delivered, 249 (18.8%) as expired and resent, 23 (1.6%) as failed, and 3 (0.2%) as sent but lacking delivery confirmation. 633 messages (45.3%) contained tiered incentive offers. Of 173 women who received at least one message, 67 (38.7%) were sent reminders only; 106 women (61.3%) were sent at least one incentivized message. Numerous challenges were encountered during the system’s implementation, despite its deliberate design to accommodate basic problems such as intermittent internet access and power failures. Continuous adaptation to increase the resilience of the system, complemented by limited backstops, resulted in a successful deployment. Conclusions: mParis’ open-source nature, auditability, and ability to autonomously execute algorithms in a low-resource setting with frequent infrastructure challenges suggest favorable prospects to automate health communication in a wide range of settings. mParis’ use in multiple other health-related research studies demonstrates its versatility and ability to accommodate challenges that may be encountered in diverse other contexts. Clinical Trial: ClinicalTrials.gov: NCT03252288
This pre-registered study aims to explore the impact of air pollution, an environmental factor, on corporate bond credit spreads. We are going to investigate three questions in this study: (1) whether air pollution exhibits a causal effect on corporate bond risk premiums? (2) what are the underlying mechanisms driving this relationship? (3) how firm-level heterogeneity modulates environmental risk sensitivity? To explore these questions, we collect corporate bonds that have traded in China's exchange markets from 2014 to 2022 to conduct an empirical analysis. These findings underscore the importance of environmental considerations, such as air pollution, in shaping corporate financial risks and investment decisions.
Background: Loneliness is a negative emotional state which is common in later life. The accumulative effects of loneliness have significant impact on physical and mental health of older adults. Automatic methods for detection and prediction are an emerging field to support early identification of loneliness. Objective: We aim to qualitatively explore the thoughts and preferences of people aged 65 and over regarding technologies to detect feelings of loneliness in later life. Methods: We conducted 60 semi-structured interviews with people aged 65 and over between September 2022 and August 2023. Data were analysed using a reflective thematic approach on NVIVO software. Results: Three themes were identified representing what older adults considered important in a system able to detect loneliness. 1) Interest and Control of Data, which was a priority for older adults; 2) Perceived Usefulness to Address Loneliness, which related to the importance of providing recommendations to reduce feelings of loneliness after detection; and 3) Personalisation as a Priority, which included the level of loneliness for which an alert was sent and selection of relevant individuals who would be sent a loneliness alert. Conclusions: Findings from this in-depth qualitative study provide important perspectives from people with lived-experience of loneliness on the context in which a sensor-based loneliness detection system would be most useful and acceptable to older adults. Future research will include such perspectives in the design of innovative technologies enabling the early detection of loneliness and access to timely interventions to tackle loneliness in later life.
Background: Thyroid cancer is one of the most commonly diagnosed malignancies in South Korea, with incidence rates among the highest globally. Young women, in particular, represent a high-risk group, likely due to a combination of biological, occupational, and environmental factors. However, the specific risk factors contributing to thyroid cancer development in this population remain poorly understood. Objective: This study aims to identify the risk factors associated with thyroid cancer among young female nurses using longitudinal survival analysis. Methods: This longitudinal study used data from the Korea Nurses’ Health Study (KNHS), a prospective national cohort of female nurses. Data from the first, fifth, seventh, and ninth surveys were used to construct a person-period data set. Female nurses aged in their 20s at baseline were included. Time-varying explanatory variables included age, marital status, BMI, smoking, alcohol consumption, perceived stress, sleep problems, nursing position, night shift work, working unit, and duration of radiation exposure. The dependent variable was self-reported physician-diagnosed thyroid cancer. Kaplan-Meier survival analysis and Cox proportional hazards regression were performed to examine the association between risk factors and thyroid cancer occurrence. Results: A total of 22,759 person-period cases were analyzed, and 105 thyroid cancer events were identified. Kaplan-Meier analysis showed significant associations between thyroid cancer occurrence and age (χ²1=51.6, P<.001), marital status (χ²1=25.1, P<.001), sleep problems (χ²1=20.3, P<.001), night shift work (χ²1=20.1, P<.001), working unit (χ²1=13.0, P<.001), and duration of radiation exposure (χ²1=91.0, P<.001). In the Cox regression model, nurses aged in their 20s had a significantly higher risk of thyroid cancer than those aged in their 30s (hazard ratio [HR] 4.602, 95% CI 1.893-11.188). Those who worked night shifts were also at an increased risk (HR 1.923, 95% CI 1.127-3.280). Compared with no exposure, radiation exposure showed a dose-response relationship: <1 year: HR 3.449, 95% CI 1.474-8.074; ≥1 year: HR 4.178, 95% CI 2.702-6.461. Conclusions: Younger age, night shift work, and duration of radiation exposure were significantly associated with an increased risk of thyroid cancer in young female nurses. These findings highlight the importance of early screening and occupational risk management, including regular radiation monitoring and support for circadian health, in health care settings.
Background: Smart displays and speakers offer voice interaction, which may be more accessible and appealing to older adults with chronic pain and other multimorbid conditions. Previous trials found stronger socioemotional benefits of ElderTree (vs control) among those with high primary care use and multiple chronic conditions. Objective: This study aims to test whether older adults with chronic pain and multiple other chronic conditions use and benefit more from ElderTree, an eHealth intervention targeting pain and quality of life, when delivered on a smart display. Methods: We recruited 269 participants from the University of Wisconsin-Madison health system and community organizations and randomly assigned 1:1:1 to (1) smart display with internet and ElderTree, plus usual care; (2) touchscreen laptop with internet and ElderTree, plus usual care; or (3) usual care alone. Participants were aged ≥60 years, had a chronic pain diagnosis or reported chronic pain, and at least 3 common chronic conditions. Primary outcomes were pain interference and psychosocial quality of life. Data sources were baseline, 4-month, and 8-month surveys and continuous ElderTree usage data. Results: No significant differences were found between the laptop versus smart display groups for pain interference (b=–0.11, 95% CI –1.07 to 0.85; P=.82) or psychosocial quality (b=–0.21, 95% CI –0.96 to 0.55; P=.56), nor between the combined laptop+smart display group versus control group for either outcome (pain interference: b=–0.41, 95% CI –1.23 to 0.41; P=.33; psychosocial quality of life: b=0.04, 95% CI –0.61 to 0.69; P=.90). Mediation was not tested because effects on primary outcomes were nonsignificant. Gender did not moderate the effect of laptop versus smart display groups in pain interference (b=–1.56, 95% CI –3.56 to 0.44; P=.13). Gender did moderate the effect of the combined laptop+smart display group versus control group (b=1.91, 95% CI 0.11 to 3.71; P=.04). Women showed a significant decrease in pain interference (b=–0.69, 95% CI –1.29 to –0.10; P=.02), whereas women in the control group showed no significant change (b=0.25, 95% CI –0.53 to 1.04; P=.53). Men in the combined group showed a nonsignificant decrease (b=–0.67, 95% CI –1.47 to 0.14; P=.10), whereas men in the control group showed a significant decrease (b=–1.61, 95% CI –2.88 to –0.35; P=.01). Participants assigned to the laptop versus smart display used ElderTree more frequently and had more favorable perceptions. Analyses of secondary and exploratory outcomes showed no significant differences between groups. Conclusions: We found no significant differences between the combined ElderTree group and the control group for changes over time in any primary, secondary, or exploratory outcomes. Moderation analyses indicated that only gender moderated study arm effects, and only for the laptop+smart display versus control group on changes over time in the two primary outcomes. Trial Registration: ClinicalTrials.gov NCT04798196; https://clinicaltrials.gov/ct2/show/NCT04798196
Background: Voice-controlled smart speakers and displays have a unique but unproven potential for delivering eHealth interventions. Many laptop- and smartphone-based interventions have been shown to improve multiple outcomes, but voice-controlled platforms have not been tested in large-scale rigorous trials. Older adults with multiple chronic health conditions, who need tools to help with their daily management, may be especially good candidates for interventions on voice-controlled devices because these patients often have physical limitations, such as tremors or vision problems, that make the use of laptops and smartphones challenging. Objective: The aim of this study is to assess whether participants using an evidence-based intervention (ElderTree) on a smart display will experience decreased pain interference and improved quality of life and related measures in comparison with participants using ElderTree on a laptop and control participants who are given no device or access to ElderTree. Methods: A total of 291 adults aged ≥60 years with chronic pain and ≥3 additional chronic conditions will be recruited from primary care clinics and community organizations and randomized 1:1:1 to ElderTree access on a smart display along with their usual care, ElderTree access on a touch screen laptop along with usual care, or usual care alone. All patients will be followed for 8 months. The primary outcomes are differences between groups in measures of pain interference and psychosocial quality of life. The secondary outcomes are between-group differences in system use at 8 months, physical quality of life, pain intensity, hospital readmissions, communication with medical providers, health distress, well-being, loneliness, and irritability. We will also examine mediators and moderators of the effects of ElderTree on both platforms. At baseline, 4 months, and 8 months, patients will complete written surveys comprising validated scales selected for good psychometric properties with similar populations. ElderTree use data will be collected continuously in system logs. We will use linear mixed-effects models to evaluate outcomes over time, with treatment condition and time acting as between-participant factors. Separate analyses will be conducted for each outcome. Results: Recruitment began in August 2021 and will run through April 2023. The intervention period will end in December 2023. The findings will be disseminated via peer-reviewed publications. Conclusions: To our knowledge, this is the first study with a large sample and long time frame to examine whether a voice-controlled smart device can perform as well as or better than a laptop in implementing a health intervention for older patients with multiple chronic health conditions. As patients with multiple conditions are such a large cohort, the implications for cost as well as patient well-being are significant. Making the best use of current and developing technologies is a critical part of this effort. Trial Registration: ClinicalTrials.gov NCT04798196; https://clinicaltrials.gov/ct2/show/NCT04798196
Background: With the ubiquity of smartphones, digital self-report instruments have enormous potential to support the general population in monitoring their mental health. A primary challenge for researchers committed to advancing this work is simply to scope the plethora of widely used candidate instruments. The overarching aim of this study was to address this challenge to support and guide future research in this burgeoning area. Objective: This study aimed to conduct a literature review of self-report instruments used in empirical studies to measure mental health (1) in the general population, (2) delivered in a digital format, and (3) in longitudinal designs. Given the wide range of recognized “mental health” constructs, the review’s search strategies were guided by Keyes’ dual continua model of mental health, recognizing both deficits- and strengths-based constructs. This study’s primary objective was to develop a first-of-its-kind ranking and synthesis of the most frequently used instruments that are potentially suitable for mental health self-monitoring. It was not an objective of this study to evaluate psychometric properties of the identified instruments—we hope the present ranking and synthesis will provide the foundation for future research into optimal digital, prospective self-report of mental health. Methods: Five major electronic databases were searched. Studies that administered digital mental health instruments (in English) repeatedly to community dwellers in the general adult population were eligible. The included studies were grouped by instruments for synthesis using a narrative approach. Results: Preliminary screening of 95,849 records identified 8460 eligible records, among which 1000 records were randomly selected over 4 iterations for full-text screening. A total of 223 records were included. We found that the top 30 most commonly used instruments accounted for 78.4% (308/393) of the total usage across studies. These instruments predominantly measure deficits-based mental health constructs. The Patient Health Questionnaire 9 Items and Generalized Anxiety Disorder 7 Items were by far the most used instruments. The most commonly measured strengths-based constructs were life satisfaction and mental well-being. Conclusions: The findings of this review strongly suggest that scientific investigation of mental health constructs across time on digital platforms still prioritizes deficits-focused instruments originally developed for pen-and-paper administration using classical test theory. These findings are discussed in light of evidence in the literature that deficits-focused instruments demonstrate inferior distributional properties (floor effects) in the general population and theory suggesting that both deficits- and strengths-focused measurements are required to holistically assess mental health. Limitations of the review include the restricted focus on English language instruments and the pragmatic approach to selecting records for full-text screening. It is concluded that, in the smartphone age, it would be timely to develop new digital instruments framed by holistic models of mental health and using contemporary test construction approaches. Trial Registration: PROSPERO CRD42022306547; https://www.crd.york.ac.uk/PROSPERO/view/CRD42022306547
While the pain- and stress-reducing effects of music are well investigated, effects of visual art and the combination of both modalities (music and visual art) are much less explored. We tested the (1) pain- and (2) stress-reducing effects of a multimodal (music + visual art) aesthetic experience—expecting stronger effects than single modal aesthetic experiences (music or visual art)—and, in an exploratory manner, (3) investigated underlying mechanisms of aesthetic experience and (4) individual differences. In a repeated-measures design (music, visual art, multimodal aesthetic experience, control), 42 female participants submitted their self-selected movingly beautiful visual artworks and music pieces to the lab, where pain and stress were induced by a cold pressor test. Pain (global pain perception, pain intensity, pain affect, pain tolerance) and stress responses (subjective reports, autonomic [electrocardiography, electrodermal activity, salivary alpha-amylase] and endocrine activity [salivary cortisol]) were measured. Individual differences of the experience, trait empathy and absorption were investigated. Exposure to multimodal art resulted in longer pain tolerance than single modality of visual art, but no difference was found for music. Other measures of pain intensity, stress intensity, and pain affect did not differ across the conditions. Regarding the mechanisms, exposure to all types of art distracted participants’ attention from pain, prompted mind wandering, and elicited greater enjoyment than the control condition. Physiological measures of electrocardiography and electrodermal activity validated our design: participants were more stressed during the cold pressor test, but no differences were observed across the four conditions. Also, no differences were found regarding cortisol and alpha-amylase. Regarding individual differences, higher trait absorption was associated with longer pain tolerance in the multimodal condition and with lower pain intensity in the music-only condition, compared to the other conditions. In conclusion, exposure to art can influence pain; however, the underlying mechanisms require further research.
This pre-registered report aims to explore the impact of cultural diversity on fintech development through the perspective of dialectal diversity. Specifically, we want to investigate three key questions: (1) Does cultural diversity influence fintech development? (2) If it does, what are the underlying mechanisms? (3) Moreover, does the impact of cultural diversity on fintech development vary across regions or households with heterogeneous characteristics? To explore these questions, we plan to utilize regional dialect data and analytical methods such as instrumental variables and fixed effects to examine fintech adoption at the household level. This report contributes to understanding the informal institutional factors underpinning the development of fintech, and provides new theoretical and practical perspectives for building a more comprehensive and inclusive fintech system.
Background: Effective disease surveillance is essential for understanding epidemiology, detecting outbreaks, and enabling timely public health responses, as demonstrated during the COVID-19 pandemic. In the UK, large-scale studies such as the ONS COVID-19 Infection Survey (CIS) monitored SARS-CoV-2 transmission but required significant resources, making them challenging to sustain in resource-limited settings. In contrast, the Virus Watch study, with a lower cost, relied on self-reported data and symptomatic testing, while SARI Watch leveraged hospital data for cost-effective surveillance. Objective: Our study evaluates Virus Watch’s effectiveness in tracking COVID-19 trends, using ONS CIS and SARI Watch as benchmarks for comparison. Methods: We used the Virus Watch prospective community cohort study to estimate COVID-19 positivity, incidence and hospitalisation rates in England and Wales from June 2020 to February 2023. We compared our findings with modelled positivity and incidence rates from ONS CIS and COVID-19 hospitalisation rates from SARI Watch using 9-week rolling Spearman’s ⍴ correlation to measure synchrony. Results: 58,628 participants were recruited into the Virus Watch study between June 2020 and March 2022, of whom 52,526 (90%) were reported to be living in England and 1,532 (2.6%) in Wales. Virus Watch estimates of COVID-19 positivity and incidence rates in England and Wales were highly correlated with those from ONS CIS. Despite lower absolute values in Virus Watch estimates, both studies showed strong global (overall ⍴s > 0.90) and local (median ⍴s > 0.75) synchrony over time. However, Virus Watch estimates of hospitalisations with COVID-19 were significantly lower and less synchronised with SARI Watch estimates (overall: 0.72, P<.001; median: 0.49, IQR 0.15-0.70). In Wales, Virus Watch estimates exhibited greater variability and lower local synchrony compared to England (overall positivity ⍴: 0.75, P<.001; overall incidence rate ⍴: 0.85, P<.001). Conclusions: Our results highlight the effectiveness of the Virus Watch approach in providing accurate estimates of COVID-19 positivity and incidence rates, even in the absence of national surveillance systems. This low-cost method can be adapted to various settings, particularly low-resource ones, to strengthen public health surveillance and inform timely interventions.
Mentalizing, the ability to attribute mental states to oneself and others, is commonly assessed using a variety of neuropsychological tests. However, whether these tools capture unique aspects of mentalizing or primarily reflect reasoning and language abilities remains unclear. This pre-registered study examines the incremental validity of four widely used mentalizing assessments: the Hinting Task, the Faux-Pas test, the Reading the Mind in the Eyes Test, and Frith–Happé Animations. We aim to determine whether these tests uniquely predict self-reported mentalizing abilities in daily life (using various self-reported indices of mentalizing) beyond general reasoning and language skills. Beyond testing the incremental validity of each test, we will also conduct several exploratory analyses, including head-to-head comparisons between the performance-based tests and multimodal associations between tests and self-report questionnaires. This study will clarify the relevance of mentalizing assessments, offering valuable implications for research and clinical practice.
Literature on person perception suggests the primacy of morality over sociability in interactions. While theories of emotion highlight the importance of adhering to socially acceptable display rules, a contentious debate surrounds whether individuals prioritize moral or sociable communication of emotions. We investigated how people perceive and react to others who falsely communicate empathic versus truthfully communicate unempathic emotions related to others' (mis)fortunes. Through three preregistered studies, we examined participants' perceptions (sociability and morality) and behavioral reactions (in a Dictator Game) by employing various paradigms (vignette and retrospective recall) and situations (e.g., promotion and lottery). Consistently across our studies, we found that participants perceived targets who truthfully communicated unempathic emotions as higher on morality and lower on sociability compared to those who falsely communicated empathic emotions. Moreover, Studies 2 and 3 revealed that participants formed more favorable impressions of, and were more willing to interact with, the target who falsely communicated empathic emotions, as opposed to those who truthfully communicated unempathic emotions. This preference was explained by perceived morality and sociability attributed to the targets. Building on these findings, we propose two follow-up studies aimed at replicating our results and extending them to a laboratory setting – a Gamble Game where participants will directly encounter an actual (mis)fortune, and a Dictator Game with an allegedly real interaction partner. Our expected findings indicate that falsely communicating empathic emotions is favored over truthfully communicating unempathic emotions, suggesting the primacy of sociability over morality in the context of communicating emotions related to others' (mis)fortunes.
It is important to understand how persuasive the most-cited climate change messaging strategies are. In five replication studies, we found limited evidence of persuasive effects of three highly cited strategies (N = 3,216). We then conducted a registered report megastudy (N = 13,544) testing the effects of the 10 most-cited climate change messaging strategies on Americans’ pro-environmental attitudes and behaviour. Six messages significantly affected multiple preregistered attitudes, with effects ranging from 1 to 4 percentage points. Persuasiveness varied little across party lines, inconsistent with theories predicting heterogeneous effects for targeted messages. No message increased pro-environmental donations, suggesting costly behaviours are difficult to influence with messaging alone. Inference of mechanisms driving effects was limited as the most impactful messages influenced multiple mediating variables. Taken together, these results identify several persuasive strategies, while also highlighting the limits of short-form messages for increasing Americans’ support for action to address climate change.
Loneliness and social isolation are associated with several negative health outcomes in older adulthood, including adverse cognitive outcomes and increased mortality risk. Between-study variability in how these constructs are defined and modeled poses a major challenge, potentially contributing to inconsistencies in previous findings. In response, this registered report leveraged a coordinated data analysis framework, applying independent but harmonized operational definitions and statistical models across 11 longitudinal studies of aging (N > 110,000) representing 20 countries. Using Cox regression, logistic regression, and multistate survival models (MSMs), we systematically examined how loneliness and social isolation—both separately and in combination—are associated with cognitive aging outcomes (no cognitive impairment, mild cognitive impairment, severe cognitive impairment) and mortality risk. Preliminary synthesized results based on random-effects meta-analysis show that loneliness and isolation both predict increased risk of dementia and death in Cox and logistic models (all ps < 0.001), with isolation showing a particularly strong link to mortality. In MSMs, however, loneliness (but not isolation) was associated with an increased risk of transitioning from no impairment to mild cognitive impairment. Loneliness and isolation were also associated with an increased risk of transitioning from mild cognitive impairment to death, but this was only true for isolation when loneliness was included in the model. Conversely, isolation appears to be most important for the transition from mild to severe cognitive impairment. Discussion will focus on the evidence for and against the generalizability and variability in associations among social disparities, cognitive outcomes, and mortality risk across individuals, time, and countries.
Different women experience hormonal contraceptives differently, reporting side effects on their sexuality that range from negative to positive. But research on such causal effects of hormonal contraceptives on psychological outcomes struggles both to identify average causal effects and capture the high heterogeneity in women’s treatment responses. In this study, we leveraged longitudinal data to improve our ability to separate the causal effects of hormonal contraceptives from other sources of association, including observed and unobserved confounding, reverse causality, and attrition. In this programmatic registered report (programmatic registered stage 1 protocol: https://osf.io/kj3h2; date of in-principle acceptance: 28/09/2023), we analyzed data from up to 5,041 women (23,130 observations), who participated in PAIRFAM, a German longitudinal panel dataset consisting of 14 waves, using Bayesian multilevel regressions. To deal with confounding and probe the robustness of findings, we implemented two analysis approaches: adjusted regression analysis and inverse probability of treatment weighting approach. We found evidence for positive average treatment effects of hormonal contraceptives on sexual frequency and sexual satisfaction, but no robust evidence for effects on desired sexual frequency. Furthermore, to move beyond average treatment effects, we analyzed heterogeneity in treatment responses. We found relatively high heterogeneity in individual treatment effects on sexual frequency and sexual satisfaction. Interindividual differences were not systematically related to individual treatment effects, and those treatment effects did not predict women’s decisions about which contraceptive method to use in the long run. Our results contribute to understanding the effects of hormonal contraceptives on sexuality in a naturalistic setting, where women adapt their choice of contraceptive method to their own experiences.
The integration of artificial intelligence (AI) in business education marks a significant shift in pedagogical approaches, yet the psychological mechanisms and contextual factors influencing its effectiveness are not yet fully understood. This registered report-stage I study aims to contribute to the field by examining the impact of AI usage on college students' academic self-efficacy and performance in business courses, with a particular focus on the role of teacher support. Drawing on self-efficacy theory, the study proposes a theoretical framework with 4 hypotheses, and employes field and online experiments to test these hypotheses. By addressing the current gaps in research, this study seeks to contribute to the academic literature on the integration of AI in business education, with a focus on self-efficacy and teacher support. The study not only deepens our understanding of the impact of AI in business education but also underscores the critical role of teacher support in shaping student outcomes in the context of AI integration.
Background: Many patients struggle to understand referral letters and discharge summaries; low health literacy is prevalent, and short consultations limit explanations. Large language models (LLMs) can translate clinical jargon into layperson language, but their impact on doctor–patient communication in real care remains untested.
As corporate attention to ESG issues continues to grow, the disagreement in ratings for the same company by different ESG rating agencies have sparked widespread discussion and concern. This report aims to explore how corporate efforts in ESG information disclosure can effectively reduce rating disagreements from the perspective of information asymmetry. Using a 2008–2022 sample of Chinese listed firms, we measure corporate ESG disclosure from annual reports and construct a metric of ESG rating divergence from ratings provided by domestic and international agencies. We examine the underlying mechanisms, including information asymmetry, analyst attention, and media oversight. We also investigate the sources of the change in ESG rating disagreement by examining whether the shift stems from domestic versus international agencies, or from incumbent versus new entrants. Besides, we examine how ESG disagreement affects corporate valuation (proxied by Tobin's Q) and how policy-driven changes in disclosure influence firm value, using a portfolio analysis approach. This report sheds light on the economic consequences of voluntary ESG information disclosure, providing support for the future establishment of unified ESG information disclosure standards.
Mesoporous silica (MS) is widely recognized as a local drug delivery system in bone-related diseases. Although MS enables controlled or sustained release and improved bioavailability of therapeutic agents, its limited native osseointegration capacity remains a critical barrier to effective bone regeneration. Numerous engineering strategies have therefore been proposed to enhance its biological performance. This scoping review protocol aims to collect studies, published from January 2015 onwards, that report evidence on the osseointegration potential (i.e., osteoconductive, osteoinductive, or proangiogenic properties) of MS bone drug delivery systems. Studies indexed in PubMed, Scopus, and Embase will be screened to identify the strategies used to improve MS-mediated bone regeneration, including structural modifications, formulation into composites, and incorporation of bioactive molecules. A structured analytical framework will be applied to explore how specific design approaches relate to biological outcomes across experimental models in vitro, in vivo, or ex vivo. The resulting scoping review will identify trends and knowledge gaps in strategies intended to enhance the osseointegration of MS bone drug delivery systems, supporting their future development and rational optimization for bone repair.
A recommendation of: Sigrid H. Ingvaldsen, Ida Svege, Jan-Ole Hesselberg Evaluation of a Funder-Driven Registered Report Initiative https://osf.io/6ynbq/files/kt2qg
Although the distinction between episodic and semantic memory is supported by numerous neuropsychological studies, neuroimaging data have shown considerable overlap between regions that are activated during semantic and episodic remembering. This might indicate similar or shared mechanisms but might also result from inadequate task designs or poor functional magnetic resonance imaging signal coverage. Here we compared neural activations and representations associated with successful retrieval of episodic and semantic memories, using tasks that are more closely matched. A total of n = 40 participants recalled pairings between logos and brand names, where the pairings corresponded to real-world knowledge (semantic task) or were learned in an initial study phase (episodic task). Neither a priori-defined networks nor clusters generally activated by our task provided evidence for any difference between successful semantic and episodic retrieval, with the Bayes factor for the a priori networks supporting the null hypothesis of no difference. Protocol registration The Stage 1 protocol for this Registered Report was accepted in principle on 15 September 2021. The protocol, as accepted by the journal, can be found at https://osf.io/dm47y/.
Using the 2021 enforcement of China's Data Security Law and Personal Information Protection Law as an external shock, this pre-registered study seeks to explore whether—and through which channels—cross-border data flow restrictions are associated with changes in multinational enterprises' financing constraints. Employing a difference-in-differences framework combined with propensity score matching and entropy-balancing matching, we aim to examine whether the regulatory shock affects multinational enterprises' financing constraints through channels related to operational efficiency and information asymmetry. We further explore how firm characteristics, such as foreign sales intensity and state ownership, may condition these effects, with the former potentially intensifying frictions and the latter possibly providing institutional resilience.
BACKGROUND: Limited empirical evidence exists on the effectiveness of a hybrid approach to heart-healthy lifestyle interventions that integrates mHealth technology with face-to-face counseling. Moreover, its superiority over exclusive mHealth use in promoting heart-healthy behavioral outcomes within a community setting remains unclear. OBJECTIVE: This study aims to evaluate the effectiveness of a hybrid community-based approach to heart-healthy lifestyle intervention incorporating a mobile application and motivational interviewing among community-dwelling adults without a history of cardiovascular disease. METHODS: We conducted a three-arm, parallel-group, randomized controlled trial with assessments at baseline and after 12 weeks. A total of 75 participants, each presenting at least one component of metabolic syndrome and no history of cardiovascular disease, were randomly assigned to one of three groups: hybrid (n=25), mobile (n=25), or control (n=25). Participants were recruited through online platform. The hybrid group underwent a 12-week hybrid intervention combining a mobile application (i.e., "My HeartHELP") and face-to-face motivational interviewing led by a nursing researcher. The mobile group used only the mobile application, while the control group received written material on general heart health. The intervention was facilitated by three trained nursing researchers. The primary outcome was a composite score of 'heart-healthy behaviors', while secondary outcomes included scores for heart-healthy 'information', 'self-efficacy', 'motivation', and cardiovascular parameters. The trial was conducted in two rounds from October 2022 to May 2023. An intention-to-treat analysis was performed. RESULTS: Of the 75 participants, 72 (96%) completed the study. Compared with the control group, both the hybrid and mobile intervention groups demonstrated significantly greater improvements in behavioral outcomes, including composite heart-healthy behavior (F=7.25, P=.001), its theoretical predictors-heart-healthy motivation (F=8.54, P< .001) and self-efficacy for diet (F=4.87, P=.011) and exercise (F=5.48, P=.006)-as well as fasting glucose levels (F=3.90, P=.025) following the 12-week intervention. Particularly, the hybrid group-unlike the mobile group-showed significantly greater improvement in dietary behavior, a subscale of heart-healthy behavior, compared with the control group, and demonstrated significantly greater improvements in Interest/Enjoyment, a core subscale of intrinsic motivation than the mobile and control groups. CONCLUSIONS: The hybrid community-based heart-healthy lifestyle intervention-integrating a mobile application and motivational interviewing-demonstrated overall effectiveness comparable to the mobile application alone, while yielding greater improvements in dietary behavior and core intrinsic motivation. These findings highlight the potential of mHealth applications as practical, standalone tools to promote cardiovascular health, particularly in community settings with limited access to in-person professional support. However, incorporating motivational interviewing may further enhance internalized motivation and complex behavior changes over time. Health professionals can therefore adopt mHealth either independently or in combination with motivational interviewing. Future studies should optimize integration strategies to enhance effectiveness and evaluate the long-term sustainability of such hybrid approaches. CLINICALTRIAL: The trial was registered on the ISRCTN (no.83643383). INTERNATIONAL REGISTERED REPORT: RR2-10.1161/circ.147.suppl_1.P147.
Background: Digital methods that enable early caries identification can streamline data collection in research and optimize dental examinations for young children. Intraoral scanners are devices used for creating 3D models of teeth in dentistry and are being rapidly adopted into clinical workflows. Integrating fluorescence technology into scanner hardware can support early caries detection. However, the performance of caries detection methods using 3D models featuring color and fluorescence in primary teeth is unknown. Objective: This study aims to assess the diagnostic agreement between visual examination (VE), on-screen assessment of 3D models in approximate natural colors with and without fluorescence, and application of an automated caries scoring system to the 3D models with fluorescence for caries detection in primary teeth. Methods: The study sample will be drawn from eligible participants in a randomized controlled trial at the Royal Children’s Hospital, Melbourne, Australia, where a dental assessment was conducted, including VE using the International Caries Detection and Assessment System (ICDAS) and intraoral scan using the TRIOS 4 (3Shape TRIOS A/S). Participant clinical records will be collected, and all records meeting eligibility criteria will be subject to an on-screen assessment of 3D models by 4 dental practitioners. First, all primary tooth surfaces will be examined for caries based on 3D geometry and color, using a merged ICDAS index. Second, the on-screen assessment of 3D models will include fluorescence, where caries will be classified using a merged ICDAS index that has been modified to incorporate fluorescence criteria. After 4 weeks, all examiners will repeat the on-screen assessment for all 3D models. Finally, an automated caries scoring system will be used to classify caries on primary occlusal surfaces. The agreement in the total number of caries detected per person between methods will be assessed using a Bland-Altman analysis and intraclass correlation coefficients. At a tooth surface level, agreement between methods will be estimated using multilevel models to account for the clustering of dental data. Results: Automated caries scoring of 3D models was completed as of October 2023, with the publication of results expected by July 2024. On-screen assessment has commenced, with the expected completion of scoring and data analysis by March 2024. Results will be disseminated by the end of 2024. Conclusions: The study outcomes may inform new practices that use digital models to facilitate dental assessments. Novel approaches that enable remote dental examination without compromising the accuracy of VE have wide applications in the research environment, clinical practice, and the provision of teledentistry. Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12622001237774; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=384632
Presented by OSF
A recommendation of: Ellen M. O'Donoghue, Pierre-Yves Oudeyer, Helene Sauzeon, Yana Fandakova, Matthias J. Gruber How curiosity enhances hippocampus-dependent learning across late childhood and early adolescence https://osf.io/c9m8d?view_only=206d69bc700347adbbc7e4d5329405e9
A recommendation of: Yusaku Takamura, Emaad Razzak, Sarah Coustaty, Jianghao Liu, Pierre Pouget, Alfredo Spagna, Paolo Bartolomeo Oculomotor Markers of Visuospatial Mental Imagery in Aphantasia and Visualizers https://osf.io/g4fzv
This pre-registered report aims to explore the interaction between entrepreneurship and poverty alleviation based on a microfinance policy perspective, trying to answer three questions: 1) whether the microfinance policy implementation will improve poor entrepreneurs' access finance? 2) If it does, what is the underlying mechanism? 3) what is the impact of the microfinance policy on local entrepreneurial vitality? To explore such three questions, we utilize microfinance poverty alleviation policy issued in China as an exogenous policy shock to conduct a triple difference-in-difference analysis. This pre-registered report expands the understanding on microfinance poverty alleviation through entrepreneurship, and provides a new perspective for consolidating the poverty alleviation performance of finance and preventing a return to poverty.
A recommendation of: Anastazja Adamczyk, Christine Mohr, Elise Dan-Glauser, Domicele Jonauskaite Registered report protocol for the Perception Census: Linking colour preferences and colour-emotion associations https://osf.io/u8h5n?view_only=d783d8c9d2564c9c916370b66f9756e0
A recommendation of: Matt N. Williams, Mathew D. Marques, Mathew Ling, Stephen R. Hill, John Kerr, Edward J. R. Clarke, Ahnya Martin, Robert M. Ross Do you really believe that? Examining the prevalence and predictors of belief in conspiracy theories when accounting for insincerity https://osf.io/saqdn/files/xeasj?view_only=5598eac28e0a4a619835eb8c9a192e80
This pre-registered report examines how Lunar Superstitions from the traditional Almanac affect investors' behavior in stock markets across the major Asian economies, including Mainland China, Hong Kong SAR, and Taiwan. We are going to investigate four questions in this study: 1) Do the Lunar superstition beliefs affect stock market returns and trading volumes in the stock markets where Chinese investors participate? 2) What are the mechanisms underlying these effects? 3) If so, under what circumstances will these effects be more pronounced? 4) What are the economic consequences of these effects? This research improves the understanding of how heuristics from superstition beliefs shape investors' decision-making when trading risky assets.
Background: Chronic low back pain is the most prevalent chronic pain condition worldwide and access to behavioral pain treatment is limited. Virtual reality (VR) is an immersive technology that may provide effective behavioral therapeutics for chronic pain. Objective: We aimed to conduct a double-blind, parallel-arm, single-cohort, remote, randomized placebo-controlled trial for a self-administered behavioral skills-based VR program in community-based individuals with self-reported chronic low back pain during the COVID-19 pandemic. Methods: A national online convenience sample of individuals with self-reported nonmalignant low back pain with duration of 6 months or more and with average pain intensity of 4 or more/10 was enrolled and randomized 1:1 to 1 of 2 daily (56-day) VR programs: (1) EaseVRx (immersive pain relief skills VR program); or (2) Sham VR (2D nature content delivered in a VR headset). Objective device use data and self-reported data were collected. The primary outcomes were the between-group effect of EaseVRx versus Sham VR across time points, and the between–within interaction effect representing the change in average pain intensity and pain-related interference with activity, stress, mood, and sleep over time (baseline to end-of-treatment at day 56). Secondary outcomes were global impression of change and change in physical function, sleep disturbance, pain self-efficacy, pain catastrophizing, pain acceptance, pain medication use, and user satisfaction. Analytic methods included intention-to-treat and a mixed-model framework. Results: The study sample was 179 adults (female: 76.5%, 137/179; Caucasian: 90.5%, 162/179; at least some college education: 91.1%, 163/179; mean age: 51.5 years [SD 13.1]; average pain intensity: 5/10 [SD 1.2]; back pain duration ≥5 years: 67%, 120/179). No group differences were found for any baseline variable or treatment engagement. User satisfaction ratings were higher for EaseVRx versus Sham VR (P<.001). For the between-groups factor, EaseVRx was superior to Sham VR for all primary outcomes (highest P value=.009), and between-groups Cohen d effect sizes ranged from 0.40 to 0.49, indicating superiority was moderately clinically meaningful. For EaseVRx, large pre–post effect sizes ranged from 1.17 to 1.3 and met moderate to substantial clinical importance for reduced pain intensity and pain-related interference with activity, mood, and stress. Between-group comparisons for Physical Function and Sleep Disturbance showed superiority for the EaseVRx group versus the Sham VR group (P=.022 and .013, respectively). Pain catastrophizing, pain self-efficacy, pain acceptance, prescription opioid use (morphine milligram equivalent) did not reach statistical significance for either group. Use of over-the-counter analgesic use was reduced for EaseVRx (P<.01) but not for Sham VR. Conclusions: EaseVRx had high user satisfaction and superior and clinically meaningful symptom reduction for average pain intensity and pain-related interference with activity, mood, and stress compared to sham VR. Additional research is needed to determine durability of treatment effects and to characterize mechanisms of treatment effects. Home-based VR may expand access to effective and on-demand nonpharmacologic treatment for chronic low back pain. Trial Registration: ClinicalTrials.gov NCT04415177; https://clinicaltrials.gov/ct2/show/NCT04415177
Background: During pandemics, effective containment and mitigation measures may also negatively influence psychological stability. As knowledge about COVID-19 rapidly evolves, global implementation of containment and mitigation measures has varied greatly, with impacts to mental wellness. Assessing the impact of COVID-19 on the mental health needs of health care workers and other workers may help mitigate mental health impacts and secure sustained delivery of health care and other essential goods and services. Objective: This study assessed the self-reported prevalence of stress, anxiety, depression, and obsessive-compulsive symptoms in health care workers and other workers seeking support through Text4Hope, an evidence-based SMS text messaging service supporting the mental health of residents of Alberta, Canada, during the COVID-19 pandemic. Methods: An online cross-sectional survey gathered demographic (age, gender, ethnicity, education, relationship, housing and employment status, employment type, and isolation status) and clinical characteristics using validated tools (self-reported stress, anxiety, depression, and contamination/hand hygiene obsessive-compulsive symptoms). Descriptive statistics and chi-square analysis were used to compare the clinical characteristics of health care workers and other workers. Post hoc analysis was conducted on variables with >3 response categories using adjusted residuals. Logistic regression determined associations between worker type and likelihood of self-reported symptoms of moderate or high stress, generalized anxiety disorder, and major depressive disorder, while controlling for other variables. Results: Overall, 8267 surveys were submitted by 44,992 Text4Hope subscribers (19.39%). Of these, 5990 respondents were employed (72.5%), 958 (11.6%) were unemployed, 454 (5.5%) were students, 559 (6.8%) were retired, 234 (2.8%) selected “other,” and 72 (0.9%) did not indicate their employment status. Most employed survey respondents were female (n=4621, 86.2%). In the general sample, the 6-week prevalence rates for moderate or high stress, anxiety, and depression symptoms were 85.6%, 47.0%, and 44.0%, respectively. Self-reported symptoms of moderate or high stress, anxiety, and depression were all statistically significantly higher in other workers than in health care workers (P<.001). Other workers reported higher obsessive-compulsive symptoms (worry about contamination and compulsive handwashing behavior) after the onset of the pandemic (P<.001), while health care worker symptoms were statistically significantly higher before and during the COVID-19 pandemic (P<.001). This finding should be interpreted with caution, as it is unclear the extent to which the adaptive behavior of health care workers or the other workers might be misclassified by validated tools during a pandemic. Conclusions: Assessing symptoms of prevalent stress, anxiety, depression, and obsessive-compulsive behavior in health care workers and other workers may enhance our understanding of COVID-19 mental health needs. Research is needed to understand more fully the relationship between worker type, outbreak phase, and mental health changes over time, as well as the utility of validated tools in health care workers and other workers during pandemics. Our findings underscore the importance of anticipating and mitigating the mental health effects of pandemics using integrated implementation strategies. Finally, we demonstrate the ease of safely and rapidly assessing mental health needs using an SMS text messaging platform during a pandemic.
Background: In addition to the obvious physical medical impact of COVID-19, the disease poses evident threats to people’s mental health, psychological safety, and well-being. Provision of support for these challenges is complicated by the high number of people requiring support and the need to maintain physical distancing. Text4Hope, a daily supportive SMS text messaging program, was launched in Canada to mitigate the negative mental health impacts of the pandemic among Canadians. Objective: This paper describes the changes in the stress, anxiety, and depression levels of subscribers to the Text4Hope program after 6 weeks of exposure to daily supportive SMS text messages. Methods: We used self-administered, empirically supported web-based questionnaires to assess the demographic and clinical characteristics of Text4Hope subscribers. Perceived stress, anxiety, and depression were measured with the 10-Item Perceived Stress Scale (PSS-10), the Generalized Anxiety Disorder–7 (GAD-7) scale, and the Patient Health Questionnaire–9 (PHQ-9) scale at baseline and sixth week time points. Moderate or high perceived stress, likely generalized anxiety disorder, and likely major depressive disorder were assessed using cutoff scores of ≥14 for the PSS-10, ≥10 for the GAD-7, and ≥10 for the PHQ-9, respectively. At 6 weeks into the program, 766 participants had completed the questionnaires at both time points. Results: At the 6-week time point, there were statistically significant reductions in mean scores on the PSS-10 and GAD-7 scales but not on the PHQ-9 scale. Effect sizes were small overall. There were statistically significant reductions in the prevalence rates of moderate or high stress and likely generalized anxiety disorder but not likely major depressive disorder for the group that completed both the baseline and 6-week assessments. The largest reductions in mean scores and prevalence rates were for anxiety (18.7% and 13.5%, respectively). Conclusions: Text4Hope is a convenient, cost-effective, and accessible means of implementing a population-level psychological intervention. This service demonstrated significant reductions in anxiety and stress levels during the COVID-19 pandemic and could be used as a population-level mental health intervention during natural disasters and other emergencies.
Background: Addressing the adverse impacts of climate change on human health requires a global effort across multiple sectors. People living in low- and middle-income countries are particularly vulnerable to the health crises induced by climate change. Therefore, context specific solutions to tackle such challenges are essential to ensure preventive measures are in place for mitigating such risks. Objective: This protocol aims to outline an integrated, participatory approach to cocreate multisectoral interventions tailored to specific environmental and health challenges in Bangladesh, India, and Indonesia. This work is done as part of the Global Health Research Centre for Non-Communicable Diseases and Environmental Change, funded by the National Institute for Health and Care Research. The overall aim is to collaboratively design and assess interventions that deliver dual benefits for planetary and human health. Methods: To address the multisectoral nature of the challenges, this study will adopt a cocreation methodology that blends co-design and coproduction approaches. While the problem areas are specific to each context—tackling air pollution due to plastic burning in Indonesia, improving dietary diversity of public food procurement systems and managing extreme heat in India, and mitigating drinking water salinity in Bangladesh—the underlying cocreation framework is consistent and can be adapted to the needs of each study setting. The workflow consists of 4 key stages guided by an existing cocreation framework: planning, developing, evaluation, and reporting, with the 6 core elements of the Medical Research Council’s complex intervention development framework embedded throughout the process. Drawing on the Double Diamond design process, the cocreation stage involves the following phases: codevelopment of a theory of change to explore potential context-specific interventions, short-listing of intervention components through gap analysis and prioritization, co-designing and coproducing selected intervention components, and assessing appropriateness and feasibility of intervention implementation. The cocreation process will be evaluated using the Research Quality Plus for Co‑Production framework to ensure methodological rigor and quality. Results: Cocreation will take place over 6 months. Sampling and recruitment of cocreators (key stakeholders across sectors) have been completed in all 3 countries, with each cocreator group consisting of 20-30 members. We have developed the tools for the cocreation phase, informed by the findings from formative research, and received the necessary ethics approval to conduct these activities. We will generate a series of academic and nonacademic outputs on the cocreation process to disseminate the findings, as well as training materials for implementers to facilitate future adoption in similar settings. Conclusions: The cocreation of multisectoral interventions to tackle both environmental change and health is a comparatively new domain of implementation research. This protocol addresses the complex, multidimensional, and unique nature of such interventions by developing a structured and scientifically sound approach to be implemented in real-life settings.
The McGurk effect is a multisensory phenomenon in which discrepant auditory and visual speech signals typically result in an illusory percept. McGurk stimuli are often used in studies assessing the attentional requirements of audiovisual integration, but no study has directly compared the costs associated with integrating congruent versus incongruent audiovisual speech. Some evidence suggests that the McGurk effect may not be representative of naturalistic audiovisual speech processing – susceptibility to the McGurk effect is not associated with the ability to derive benefit from the addition of the visual signal, and distinct cortical regions are recruited when processing congruent versus incongruent speech. In two experiments, one using response times to identify congruent and incongruent syllables and one using a dual-task paradigm, we assessed whether congruent and incongruent audiovisual speech incur different attentional costs. We demonstrated that response times to both the speech task (Experiment 1) and a secondary vibrotactile task (Experiment 2) were indistinguishable for congruent compared to incongruent syllables, but McGurk fusions were responded to more quickly than McGurk non-fusions. These results suggest that despite documented differences in how congruent and incongruent stimuli are processed, they do not appear to differ in terms of processing time or effort, at least in the open-set task speech task used here. However, responses that result in McGurk fusions are processed more quickly than those that result in non-fusions, though attentional cost is comparable for the two response types.
Background: Vocational school students exhibit a high prevalence of addictive behaviors. Mobile phone–based prevention programs targeting multiple addictive behaviors and promoting life skills are promising. Tailoring intervention content to participants’ preferences, such as allowing them to choose behavior modules, may increase engagement and efficacy. There is limited understanding of how personal characteristics relate to module choices. Objective: This study examined the prevention needs of German vocational school students as well as their prevention preferences through self-determined module choice in the multibehavior app-based addiction prevention program ready4life. Methods: A 2-arm cluster randomized controlled trial recruited German vocational school students aged ≥16 years. Among 376 classes from 35 schools, ready4life was introduced during a school lesson. Students were invited to download the ready4life app and completed an anonymous screening with individualized risk and competence feedback in the form of a traffic light system. Informed consent was provided by 2568 students. Intervention classes received individual app-based coaching with weekly chat contacts with a conversational agent over 4 months. They could choose 2 of 6 modules: alcohol, tobacco, cannabis, social media and gaming, stress, and social competencies. Control group classes received a link to health behavior information and could access coaching after 12 months. Results: Prevention need was high. For 86.2% (2213/2568), ≥2 risks were reported based on yellow or red traffic light feedback. Within the intervention group, stress (818/1236, 66.2%) and social media and gaming (625/1236, 50.6%) were the most chosen topics, followed by alcohol (360/1236, 29.1%), social competencies (306/1236, 24.8%), tobacco (232/1236, 18.8%), and cannabis (131/1236, 10.6%). Module choices closely aligned with received traffic light feedback among those with 1 or 2 risks. Multilevel regression models showed that women were significantly more likely to choose the stress module (odds ratio [OR] 2.38, 95% CI 1.69-3.33; P<.001); men preferred social media and gaming (OR 0.52, 95% CI 0.40-0.69; P<.001), alcohol (OR 0.50, 95% CI 0.37-0.67; P<.001), and cannabis (OR 0.37, 95% CI 0.21-0.63; P<.001) when holding age, educational track, and prevention need for the corresponding behavior constant. Younger students were significantly more likely to choose the cannabis module (OR 0.81, 95% CI 0.74-0.90; P<.001). Educational track also influenced module choice (eg, those with a lower educational level were more likely to choose alcohol and cannabis, suggesting a positive equity impact). Students’ prevention needs significantly influenced choice of the module (eg, higher alcohol consumption increased the likelihood of choosing the alcohol module; OR 1.31, 95% CI 1.20-1.43; P<.001). Conclusions: Our study confirms vocational school students’ high prevention needs regarding addictive behaviors. Students’ module choices were highly congruent to their demonstrated needs, with most students being interested in the stress module. Module choice also differed by age, gender, and educational track. Trial Registration: German Clinical Trials Register DRKS00022328; https://drks.de/search/en/trial/DRKS00022328
Background: Multimorbidity, the presence of 2 or more chronic conditions, is becoming increasingly prevalent worldwide, resulting in significant impacts on health care systems. For people with multimorbidity, self-management is challenging, requiring engagement in several tasks. Digital health platforms have been widely acknowledged as having the potential to enhance self-management practices for those with chronic conditions. However, limited longitudinal studies have explored the effectiveness of digital health platforms that support multimorbidity self-management or issues relating to their implementation and scalability in practice. Objective: The aim of this study is to determine the effectiveness and implementation of a digital health platform, ProACT, with support services including clinical triage and a care network (consisting of informal and formal caregivers and health care professionals) compared to the use of the platform alone and compared to standard care. Methods: An effectiveness-implementation type 1 hybrid study will be conducted across 3 European countries. A total of 720 older adults aged 65 years or older with multimorbidity (2 or more of the following: diabetes, a chronic respiratory disease, chronic heart failure, and chronic heart disease) will be recruited and randomized into 1 of 3 trial arms. Those in trial arm 1 will be invited to have up to 5 care network members participate with them, resulting in a maximum of 1500 care network participants. Effectiveness will be assessed through a 3-arm pragmatic randomized controlled trial, while implementation issues will be addressed via a process evaluation. Primary outcomes for participants with multimorbidity are quality of life and health care use, while secondary outcomes focus on the potential of the ProACT platform to support multimorbidity self-management (eg, self-efficacy, usability, engagement, and symptom stabilization). Primary outcomes for informal caregivers in the care network include caring burden, while secondary outcomes for all care network members include usability, engagement, satisfaction, and overall experiences with ProACT. Additional outcomes related to the process evaluation include the reach, uptake, and fidelity of implementation of ProACT and the way organizations implement and deliver ProACT; how they differ in this regard; and the factors underpinning these differences. A range of qualitative and quantitative data will be collected and analyzed to assess these outcomes. Results: Enrollment in the trial began in September 2022, and the trial is anticipated to end by March 2026. Trial outcomes will be submitted for publication in 2026. Conclusions: The generation of evidence-based support for the routine use of the ProACT platform in applied settings would represent considerable impact. With health care services under increasing strain and traditionally designed to support those with single morbidities, it is more important than ever to develop actionable insights and resources to empower persons with multimorbidity to self-manage their complex care needs at home, with support from their caregivers. Trial Registration: ISRCTN Registry ISRCTN34134007; https://www.isrctn.com/ISRCTN34134007