Apple Heart & Movement Study

NCT04198194 | Active Not Recruiting DMC

• 1 other identifier: 2019P002257
• Study Type: observational
• Target: 500,000
• Locations: 1 country
• Sites: 1

Brief Summary

This study will look for factors that affect heart health and potentially cause deterioration in mobility or heart function. Participant's Apple Watch and iPhone can help researchers gain a better understanding of potential early warning signs. This can lead to new interventions and products that will help millions lead longer, healthier, and more active lives.

Conditions

Prevention

Outcome Measures

Primary Outcomes (1)

• Number of Participants with Chronic Disease Events

  Change in number of participants with incident cardiovascular disease events (including myocardial infarction, coronary revascularization, heart failure hospitalization, stroke/TIA hospitalization, atrial fibrillation, and atrial fibrillation hospitalization), fall events, and other hospitalizations, assessed by patient report.

  quarterly (every 90 days) through study completion (up to 5 years)

Study Arms (2)

Participants with events

Individuals who have experienced any of the listed outcomes

Diagnostic Test: Predictors of events

Participants without events

Individuals who have not experienced any of the listed outcomes

Interventions

Predictors of events DIAGNOSTIC_TEST

Apple Heart \& Movement Study in Apple Research app

Participants with events

Eligibility Criteria

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

Study Population

Participants will self-enroll in this trial, if they meet inclusion criteria, and there will be no active recruitment of any particular population. Invitation to volunteer.

You may qualify if:

• Be at least 18 years old (at least 19 years old in Alabama and Nebraska, at least 21 years old in Puerto Rico);
• Live in the United States of America;
• Have an iPhone;
• Have an Apple Watch (Series 1 or later) at the time of enrollment;
• Have the Apple Research app installed on your iPhone;
• Be comfortable communicating in written and spoken English;
• Not share your iCloud account, iPhone, or Apple Watch with anyone else;
• Be willing and able to provide informed consent to participate in the study.

Sponsors & Collaborators

• Apple Inc.: lead
• American Heart Association: collaborator

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Study Officials

• Calum A MacRae, MD, PhD

  cmacrae@bwh.harvard.edu

  PRINCIPAL INVESTIGATOR

• Angela M Spillane

  amspillane@bwh.harvard.edu

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 13, 2019
• First Posted: December 13, 2019
• Study Start: November 14, 2019
• Primary Completion: February 28, 2025
• Study Completion: February 28, 2025
• Last Updated: February 21, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)