Clinical Research Directory

Data Donation Model for Inclusive Cardiovascular Prevention Using the TRAIN Health Platform

Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Summary

Cardiovascular disease (CVD) is the leading cause of death in the Netherlands and worldwide. While prevention strategies have improved, many population groups, including women, individuals with a migration background, and people with lower socioeconomic status, remain underrepresented in cardiovascular research and prevention programs. As a result, current risk prediction models and lifestyle recommendations are based largely on homogeneous datasets that do not reflect real-world diversity. This structural imbalance limits the generalisability of evidence and contributes to persistent health disparities. The Data Donation Model (DDM) aims to address this gap by introducing a citizen-led, transparent, and participatory approach to data sharing for cardiovascular prevention and health research. In this model, individuals voluntarily contribute their lifestyle, behavioural, and wearable/app data for research while maintaining full control over consent and use. The DDM incorporates dynamic electronic consent, granular sharing options, and transparency dashboards that allow participants to view how their data contribute to ongoing research projects. This participatory design strengthens trust, autonomy, and inclusiveness in data governance. This study evaluates the feasibility, inclusiveness, and acceptability of implementing the DDM at scale within the general population. It forms the pilot phase of a broader national data donation infrastructure coordinated by Amsterdam UMC in collaboration with the TRAIN Health Awareness Platform (technical partner) and community organisations. Approximately 450 participants will take part in this first phase, with future expansion planned up to 10,000 citizens. Participants can connect any wearable device or health app (such as a smart ring, smartwatch, or fitness tracker) to the TRAIN platform and complete short digital questionnaires on lifestyle, sleep, stress, and wellbeing. All participants can donate data for up to 5 years, with the freedom to stop or modify consent at any time. An optional 12-week TRAIN Heart Journey provides guided feedback on physical activity, stress, and recovery patterns, but participation in this module is not required for data donation. The main outcomes are (1) feasibility and acceptability of the DDM (recruitment, retention, adherence, and user satisfaction), (2) inclusiveness of participation across demographic groups, and (3) trust and engagement with science and data governance. Secondary outcomes include behavioural and physiological changes (activity, sleep, stress) and self-efficacy. Exploratory analyses will evaluate long-term engagement and, for consenting participants, linkage with official mortality data from Statistics Netherlands (CBS). The findings will inform future national strategies for equitable, citizen-driven cardiovascular prevention and contribute to developing inclusive guidelines based on real-world data from diverse populations.

Official title: The Data Donation Model: Redefining Citizen Participation in Inclusive Cardiovascular Prevention and Care

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