- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06958523
- Original Trial
Apple Health Study
The Apple Health Study aims to build a diverse and inclusive group of participants to help researchers advance our understanding of how signals and information collected from apps and devices relate to health and may be used to predict, detect, monitor, and manage changes in health.
To enroll, US residents who have an iPhone can download the Apple Research app from the App Store and go through the introduction and informed consent for the Apple Health Study. This study is fully remote, and all are invited to enroll if the eligibility criteria are met.
Participants will be asked to complete tasks and surveys, using their iPhone and Apple Research app which include:
- Selecting the types of data they would like to share with the study such as health and sensor data
- Completing tasks and surveys including areas such as personal demographic information, personal medical history, family history, and social determinants of health
Study Overview
Status
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: MCRA Study Call Center
- Phone Number: 833-600-6993
- Email: applehealthstudy@bwh.harvard.edu
Study Locations
-
-
District of Columbia
-
Washington, District of Columbia, United States, 20001
- Recruiting
- MCRA
-
Contact:
- Study Call Center
- Phone Number: 833-600-6993
-
Principal Investigator:
- Tiffany Avery, MD
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02115
- Recruiting
- Brigham and Women's Hospital
-
Contact:
- Angela Spillane, MS
- Email: applehealthstudy@bwh.harvard.edu
-
Principal Investigator:
- Calum MacRae, MD, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
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 installed Apple Research app on your iPhone;
- Be comfortable communicating in written and spoken English;
- Be willing and able to provide informed consent to participate in the Study.
Exclusion Criteria:
- Share your iCloud account, iPhone, or devices that collect health data such as Apple Watch with anyone else, because it could result in sharing another person's health information with the Study, making it challenging for researchers to use your information.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Health Status
Time Frame: Baseline and every 6 months until study end (up to 5 years)
|
Assessed by participant self-report as well as clinical health records and claims data.
The initial count and change over time in the number and type of health conditions such as cardiovascular, circulatory, cognition, hearing, mental health, metabolic, mobility, neurologic, respiratory, sex and gender, reproduction, hormones, sleep, and health events such as hospitalizations, procedures or falls.
|
Baseline and every 6 months until study end (up to 5 years)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Participant Population: Demographic Characteristics of Study Participants
Time Frame: Baseline and annually until study end (up to 5 years)
|
Results of surveys to report participant demographics.
|
Baseline and annually until study end (up to 5 years)
|
|
Social Determinants of Health: Lifestyle & Environment Survey
Time Frame: Baseline and every 6 months until study end (up to 5 years)
|
Results of surveys that collect information about social determinants of health.
|
Baseline and every 6 months until study end (up to 5 years)
|
|
Family Health History in Health Conditions and Health Events
Time Frame: Baseline and have option to update if needed (up to 5 years)
|
Results of self-reported family health history of first-degree biologic family.
|
Baseline and have option to update if needed (up to 5 years)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Calum MacRae, MD, PhD, Brigham and Women's Hospital
- Principal Investigator: Tiffany Avery, MD, MCRA
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- Pro00081895
- 2024P003608 (Other Identifier: Brigham and Women's Hospital IRB)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.