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

NCT07238036 | Not Yet Recruiting

• 1 other identifier: METC 2025.0762
• Study Type: observational
• Target: 450
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Cardiovascular Diseases (CVD)

Keywords

cardiovascular prevention; data donation; citizen science; health equity; participatory research; digital health; wearable data; lifestyle monitoring; trust in science; inclusiveness; population health; prevention research; FAIR data; Open Science

Outcome Measures

Primary Outcomes (5)

• Recruitment Rate

  Number of participants enrolled per month during the active recruitment period. Recruitment rate reflects the feasibility of enrolling adults from the general population into the Data Donation Model (DDM) via the TRAIN Health Awareness Platform. Unit of Measure: Participants per month

  From study start until end of recruitment (anticipated 12 months).

• Retention Rate at 12 Weeks

  Proportion of enrolled participants who complete the 12-week follow-up period with at least one questionnaire assessment. This measure reflects the feasibility of retaining participants in a fully digital observational study. Unit of Measure: Percentage of participants (%)

  From enrolment to 12 weeks after enrolment.

• Adherence to Wearable and App Use

  Proportion of follow-up days with any recorded wearable or app data (e.g., activity, sleep, or heart-rate-derived signals), calculated per participant and summarised at group level. This measure reflects adherence to using the connected device(s) and the TRAIN platform in daily life. Unit of Measure: Percentage of follow-up days with data (%)

  From enrolment to 12 weeks after enrolment.

• Wearable Data Completeness

  Proportion of expected data points that are successfully captured and stored for each participant over the 12-week period, based on predefined minimum criteria for valid days (e.g., ≥1 full day of activity and sleep data). This reflects the technical feasibility of continuous data capture within the Data Donation Model. Unit of Measure: Percentage of expected data points (%)

  From enrolment to 12 weeks after enrolment.

• Participant Satisfaction Score

  Overall satisfaction with the Data Donation Model and the TRAIN platform, measured using a brief user experience questionnaire with items rated on a 5-point Likert scale (1 = strongly disagree to 5 = strongly agree). The primary outcome is the mean total score; higher scores indicate greater satisfaction and acceptability. Unit of Measure: Mean score on a 1-5 Likert scale (points)

  At 12 weeks after enrolment.

Secondary Outcomes (12)

• Change in Daily Step Count

  Baseline to 12 weeks.

• Change in Active Minutes per Day

  Baseline to 12 weeks.

• Change in Heart Rate Variability

  Baseline to 12 weeks.

• Change in Resting Heart Rate

  Baseline to 12 weeks.

• Change in Sleep Efficiency

  Baseline to 12 weeks.

Study Arms (1)

DDM General Population Cohort

This cohort includes adults residing in the Netherlands who voluntarily participate in the Data Donation Model (DDM) through the TRAIN Health Awareness Platform. Participants provide electronic informed consent, connect wearable devices or health apps, and share lifestyle and wellbeing data for up to five years. An optional 12-week TRAIN Heart Journey module offers guided feedback on activity, sleep, and stress, but participation in this module is not required for data donation. Participants can modify or withdraw consent at any time. No randomisation, assignment, or blinding is used.

Other: Digital Lifestyle Feedback Module (optional)

Interventions

Digital Lifestyle Feedback Module (optional) OTHER

An optional 12-week digital feedback module offered within the TRAIN platform to participants who choose to engage with guided lifestyle support. This is not an assigned intervention but part of the broader participatory data-donation framework.

DDM General Population Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults from the general population voluntarily participating in the TRAIN Health Awareness Platform under the Data Donation Model (DDM). Participants may be healthy or have known cardiovascular risk factors such as hypertension, diabetes, or obesity. Recruitment occurs via digital enrolment, primary care outreach, and community organisations. Participation is nationwide and decentralised, with data collection entirely digital and no site-based visits.

You may qualify if:

• Adults (≥18 years)
• Access to a smartphone, tablet, or computer with internet connection.
• Ability to provide electronic informed consent (in Dutch or with supported translation).
• Willingness to contribute lifestyle, health, and/or wearable data through the TRAIN Health Awareness Platform.
• Optional: interest in participating in the 12-week TRAIN Heart Journey for personalised lifestyle feedback.

You may not qualify if:

• Inability to provide informed consent, even with support.
• Severe cognitive or psychiatric impairment limiting safe participation.
• Inability to use digital devices, even with assistance.
• Concurrent participation in another behavioural or interventional study that could interfere with data collection.

Sponsors & Collaborators

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

MeSH Terms

Conditions

Cardiovascular Diseases

Central Study Contacts

Nimrat Grewal, MD, PhD

CONTACT

+31 20 566 9111; n.grewal@amsterdamumc.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 20, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: November 20, 2025

Record last verified: 2025-11