My Heart Counts Cardiovascular Health Study: Next Gen
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Personalized LLM Coaching, Generic Activity Prompts.
- Who it may be relevant to
- Registry conditions: Cardiovascular Health, Physical Activity. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
My Heart Counts Cardiovascular Health Study
Overview
The My Heart Counts Cardiovascular Health Study will utilize mobile health capabilities of smartphones to assess daily activity measures and compare these to measures of cardiovascular health risk factors and fitness. The study aims to collect cardiovascular health data on a diverse population by making the application available on both iOS and Android platforms. Using smartphone sensors and connected devices, the study will collect physical activity metrics, heart rate data, and responses to health questionnaires. The study includes a randomized crossover trial component examining the effectiveness of personalized activity coaching prompts generated by a language model compared to generic prompts.
Detailed description
My Heart Counts is a smartphone-based mobile cardiovascular health research study designed to collect data on physical activity and heart health across a broad population. This new version expands on the original study (IRB-31409) with several key improvements: inclusion of Android users alongside iOS, creation of a Spanish-language version, and, for future versions of the app, development of a platform architecture that can host multiple sub-studies.
The study will utilize smartphone sensors and connected devices to measure physical activity patterns, fitness levels through standardized tests (6-minute walk test, 12-minute run/walk test), and cardiovascular risk factors reported through health questionnaires. All data collection occurs remotely through participants' smartphones without requiring clinical visits.
A key component of the study is a 14-day randomized crossover trial evaluating the effectiveness of different physical activity coaching approaches.
Participants will experience both personalized coaching messages generated by a large language model and standard activity prompts, each for 7 days, in a randomly assigned order. The primary outcome will be the change in physical activity levels between intervention periods.
The study will serve as a digital biobank, with data made available to qualified researchers after appropriate de-identification. This platform approach will enable efficient recruitment for future cardiovascular health sub-studies without requiring development of new applications.
Interventions
- Behavioral Personalized LLM Coaching
Participants receive daily text messages containing exercise coaching prompts generated by a large language model (LLM) that are personalized to the user's demographic information for a period of 7 days. - Behavioral Generic Activity Prompts
Participants receive generic daily activity prompts for a period of 7 days (e.g., "Push yourself! Reach 10,000 steps today.")
Primary outcome measures
- Change in Physical Activity levels [Time frame: Time Frame: 14 days (7 days in each intervention period)]
Eligibility criteria
Inclusion criteria
- 18 years of age or older
- Resident of the United States
- Able to read, understand and consent to study
Exclusion criteria
- Not owning a compatible iOS or Android smartphone
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07428122 · 78735