The Data Donation Model: Redefining Citizen Participation in Inclusive Cardiovascular Prevention and Care
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 450
- 主要终点
- Recruitment Rate
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Recruitment Rate
时间窗: From study start until end of recruitment (anticipated 12 months).
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
Retention Rate at 12 Weeks
时间窗: From enrolment to 12 weeks after enrolment.
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 (%)
Adherence to Wearable and App Use
时间窗: From enrolment to 12 weeks after enrolment.
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 (%)
Wearable Data Completeness
时间窗: From enrolment to 12 weeks after enrolment.
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 (%)
Participant Satisfaction Score
时间窗: At 12 weeks after enrolment.
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)
次要结局
- Change in Daily Step Count(Baseline to 12 weeks.)
- Change in Active Minutes per Day(Baseline to 12 weeks.)
- Change in Sleep Efficiency(Baseline to 12 weeks.)
- Change in Trust in Medical Research(Baseline and 12 weeks.)
- Change in Perceived Transparency(Baseline to 12 weeks.)
- Change in Heart Rate Variability(Baseline to 12 weeks.)
- Change in Resting Heart Rate(Baseline to 12 weeks.)
- Change in Health-Related Quality of Life (EQ-5D-5L)(Baseline to 12 weeks after enrolment.)
- Long-Term Data Donation and Engagement(Up to 5 years after enrolment.)
- Change in Self-Efficacy (GSES)(Baseline to 12 weeks.)
- Inclusiveness of Participation(During and after completion of 12-week period.)
- Mortality Linkage (Optional, CBS Data)(Up to 5 years after enrolment.)
研究者
Nimrat Grewal
Prof. Dr.
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)