Apple Heart & Movement Study

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.

Study Overview

• Status: Recruiting
• Conditions: Prevention
• Intervention / Treatment: Diagnostic test: Predictors of events

• Study Type: Observational
• Enrollment (Anticipated): 500000

Contacts and Locations

• Study Contact: Name: Research Studies Support Center; Phone Number: 833-237-3881; Email: AppleHeartandMovementStudy@bwh.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Recruiting
      • Brigham and Women's Hospital
      • Contact: Calum MacRae, MD, PhD; Phone Number: 617-525-9914; Email: cmacrae@bwh.harvard.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• 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.

Description

Inclusion Criteria:

• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Participants with events; Individuals who have experienced any of the listed outcomes	Diagnostic test: Predictors of events; Apple Heart & Movement Study in Apple Research app
Participants without events; Individuals who have not experienced any of the listed outcomes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: Apple Inc.
• Collaborators: American Heart Association
• Investigators: Principal Investigator: Calum MacRae, MD, PhD, cmacrae@bwh.harvard.edu

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 14, 2019
• Primary Completion (ANTICIPATED): November 14, 2024
• Study Completion (ANTICIPATED): November 14, 2024

Study Registration Dates

• First Submitted: November 13, 2019
• First Submitted That Met QC Criteria: December 12, 2019
• First Posted (ACTUAL): December 13, 2019

Study Record Updates

• Last Update Posted (ACTUAL): July 23, 2021
• Last Update Submitted That Met QC Criteria: July 19, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 2019P002257

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No