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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04198194
Other study ID # 2019P002257
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 14, 2019
Est. completion date November 14, 2024

Study information

Verified date July 2021
Source Apple Inc.
Contact Research Studies Support Center
Phone 833-237-3881
Email AppleHeartandMovementStudy@bwh.harvard.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 500000
Est. completion date November 14, 2024
Est. primary completion date November 14, 2024
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Predictors of events
Apple Heart & Movement Study in Apple Research app

Locations

Country Name City State
United States Brigham and Women's Hospital Boston Massachusetts

Sponsors (2)

Lead Sponsor Collaborator
Apple Inc. American Heart Association

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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)
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