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

Background and Rationale Cardiovascular disease (CVD) remains the leading global cause of mortality. Although preventive strategies have advanced, many population groups continue to be structurally underrepresented in research, including people with a migration background, lower socioeconomic status, lower health literacy, and women. As a result, current datasets and risk prediction models do not accurately reflect population diversity, which limits generalisability and contributes to persistent health inequities.

The Data Donation Model (DDM) aims to address these gaps by offering a citizen-driven, transparent approach to sharing lifestyle, behavioural, and wearable/app-derived health data for preventive cardiovascular research. The DDM allows participants to maintain full control over data use through dynamic electronic consent, granular sharing settings, and real-time insight into how their data contribute to research. This approach operationalises ethical principles of autonomy, transparency, and reciprocity, and aligns with modern frameworks for Responsible Data Stewardship and FAIR/Open Science.

Study Purpose This pilot study evaluates whether the DDM can be implemented at scale within the general population. The focus is on operational feasibility, user experience, inclusiveness of participation, and engagement with dynamic consent tools. Results will guide the development of a long-term, citizen-governed data infrastructure for cardiovascular prevention research.

Study Design This is a prospective, observational cohort study with digital enrolment and follow-up. Participation is open to adults from the general population without recruitment through clinical centres. The study infrastructure is hosted on the TRAIN Health Awareness Platform, which facilitates data donation and device/app integration. Approximately 450 participants will be enrolled during this pilot phase.

Participants voluntarily connect one or more wearable devices or health applications of their choice. They also complete periodic questionnaires via the platform. An optional 12-week digital lifestyle module ("TRAIN Heart Journey") is available but not assigned as part of the research design. Data donation may continue for up to five years, depending on individual consent preferences.

Procedures and Data Streams

After electronic informed consent, participants gain access to a personal dashboard where they can:

connect their chosen wearable(s) or health app(s);

manage consent settings;

complete lifestyle and wellbeing questionnaires;

monitor their own engagement and data-sharing status.

Collected data include device-generated behaviour and wellbeing indicators (e.g., activity metrics, sleep patterns, physiological parameters depending on device type), as well as digital questionnaire responses. No biospecimens are collected, and no identifiable data are used for analysis; all data are pseudonymised at source.

Analytical Framework Feasibility will be evaluated using technical performance indicators (data transmission stability, completeness), recruitment and retention characteristics, and participant engagement metrics. Inclusiveness will be assessed using demographic distributions and literacy indicators. Exploratory analyses will focus on long-term participation patterns and-where separately consented-linkage to national mortality records via secure legal frameworks.

Quantitative analyses may include longitudinal modelling of device-based behavioural and physiological signals and descriptive analysis of user-platform interactions. Qualitative and mixed-methods analyses may be used to explore trust, transparency, and participant experience with the DDM.

Data Management and Protection All data handling complies with the General Data Protection Regulation (GDPR). Data are stored in a secure, Health-RI-aligned cloud environment using encryption, pseudonymisation, and role-based access controls. Participants may modify or withdraw consent at any time through the dynamic consent interface. Optional linkage to external datasets (e.g., mortality data) requires additional explicit consent.

Ethical Considerations The Medical Ethics Review Committee determined that the study does not fall under the Dutch Medical Research Involving Human Subjects Act (non-WMO). The study does not involve investigational products or assigned interventions and poses minimal risk. Participation is voluntary and withdrawal has no consequences.

Dissemination Results will be disseminated through peer-reviewed publications, scientific conferences, and citizen-focused communication channels facilitated by the TRAIN Health Awareness Platform and partner community organisations. Insights from this pilot will inform the subsequent scale-up of a national, citizen-driven data donation infrastructure designed to support equitable, population-representative cardiovascular prevention.

• Change in Daily Step Count [Срок оценки: Baseline to 12 weeks.]
• Change in Active Minutes per Day [Срок оценки: Baseline to 12 weeks.]
• Change in Heart Rate Variability [Срок оценки: Baseline to 12 weeks.]
• Change in Resting Heart Rate [Срок оценки: Baseline to 12 weeks.]
• Change in Sleep Efficiency [Срок оценки: Baseline to 12 weeks.]
• Change in Health-Related Quality of Life (EQ-5D-5L) [Срок оценки: Baseline to 12 weeks after enrolment.]
• Change in Self-Efficacy (GSES) [Срок оценки: Baseline to 12 weeks.]
• Inclusiveness of Participation [Срок оценки: During and after completion of 12-week period.]
• Change in Trust in Medical Research [Срок оценки: Baseline and 12 weeks.]
• Change in Perceived Transparency [Срок оценки: Baseline to 12 weeks.]
• Long-Term Data Donation and Engagement [Срок оценки: Up to 5 years after enrolment.]
• Mortality Linkage (Optional, CBS Data) [Срок оценки: Up to 5 years after enrolment.]