My Heart Counts Cardiovascular Health Study: Next Gen

Официальное название

My Heart Counts Cardiovascular Health Study

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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.
• Поведенческое Generic Activity Prompts
  Participants receive generic daily activity prompts for a period of 7 days (e.g., "Push yourself! Reach 10,000 steps today.")

Первичные конечные точки

• Change in Physical Activity levels [Срок оценки: Time Frame: 14 days (7 days in each intervention period)]

Критерии участия

Критерии включения

• 18 years of age or older
• Resident of the United States
• Able to read, understand and consent to study

Критерии исключения

• Not owning a compatible iOS or Android smartphone

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07428122 · 78735

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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