The study of determinants of cardiovascular disease (CVD) is important because it provides insight in risks and opportunities to reduce the burden of CVD. A major gap in our current knowledge about CVD lies in the way we measure these determinants,…
Brief title
Health condition
Cardiovascular disease
eHealth
Observational study
Feasibility
Hart- en vaatziekten
eHealth
Observationeel onderzoek
Haalbaarheid
Smartphone
Sponsors and support
Intervention
Outcome measures
Primary outcome
Study the effectiveness of four coaching interventions in increasing daily activity of MyHeart Counts app users.
Secondary outcome
- Study the feasibility (technical, legal and ethical, data quality, costs) of the MyHeart Counts app in the Dutch ambulatory population.
- Study the association of determinants (Diet, Smoking, Well-being, Risk perception of cardiovascular disease, Physical activity, Sleep) of cardiovascular disease with self-reported cardiovascular health.
- Subgroup analysis of primary endpoint. Test whether a particular cluster of individuals will respond more or less favourably to a particular prompt.
Background summary
This is an app-based randomized intervention study in The Netherlands, studying the effectiveness of four smartphone coaching interventions in increasing daily activity. The app has been succesfully released by Stanford University, USA, however, the effect and feasibility of the app for use in The Netherlands has not been established yet. We will therefore also be performing a feasibility study. As well as that, we aim to study the association between determinants of cardiovascular disease (CVD) with self-reported cardiovascular health. Everybody in The Netherlands aged 18 and older is invited to join to MyHeart Counts.
Study objective
The study of determinants of cardiovascular disease (CVD) is important because it provides insight in risks and opportunities to reduce the burden of CVD. A major gap in our current knowledge about CVD lies in the way we measure these determinants, for example physical activity. This is currently restricted to paper questionnaires and short-duration measurements. Here lies the potential for smartphone technology. The ResearchKit MyHeart Counts app allows researchers to collect data continuously and in large populations. Additionally, in-app coaching could stimulate a healthy lifestyle. However, the effect of different coaching levels on a smartphone is not yet known. The MyHeart Counts app has been released successfully in the USA by Stanford University. The effect and feasibility of this method for use in the Netherlands has not been established.
Study design
June 2018 - May 2021: study preparations, e.g. establishing electronic informed consent procedure, build a safe and legally adequate data exchange infrastructure, tailor app code to Dutch situation, implement Dutch cardiovasculair risk tool, etc.
May 2021: App launch, start of study
Intervention
Different coaching promts (iPhone notifications)
Inclusion criteria
Participants should be:
- Aged 18 years or older
- Living in the Netherlands
- Own an iPhone 5s or higher with the latest software (at least iOS8)
Exclusion criteria
All participants not meeting the inclusion criteria are not allowed to enter the study.
Design
Recruitment
IPD sharing statement
(Historical) registrations known in this register
In other registers
| Register | ID |
|---|---|
| NTR-new | NL7230 |
| NTR-old | NTR7429 |
| CCMO | NL61951.058.18 |