mHealth App for High Blood Pressure

(myBPmyLife Trial)

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen by Brahmajee K Nallamothu, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of Michigan

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial uses a smartwatch and a phone app to help people with high blood pressure be more active and eat less salt by sending them reminders. The goal is to see if these reminders can help lower their blood pressure.

Research Team

Brahmajee K Nallamothu, MD

Principal Investigator

University of Michigan

Eligibility Criteria

This trial is for English-speaking adults with high blood pressure who haven't changed their hypertension medication in the last month. They must own a smartphone compatible with the myBPmyLife app and have internet access. People can't join if they're advised against exercise or low-sodium diets, have very high blood pressure, secondary causes of hypertension, heart failure, kidney disease, issues using a blood pressure cuff or smartwatch due to size, consume less than 1500 mg/day sodium, or are currently/potentially pregnant.

Inclusion Criteria

Fluent in spoken and written English

Signed written informed consent. (Note that each participant must be able to consent for themselves.)

You have a history of high blood pressure and have not changed your high blood pressure medication in the last 4 weeks.

Exclusion Criteria

Contraindication to performing physical activity or following a sodium restriction diet. The participant must be able to walk and eat on their own without assistive devices

Your blood pressure is very high and unstable when you join the study.

You have conditions like adrenal insufficiency, pheochromocytoma, heart failure, or severe kidney disease that cause high blood pressure.

Treatment Details

Interventions

• Dietary and physical activity JITAI delivered through the myBPmyLife app (Behavioral Intervention)

Trial Overview The study tests whether notifications from a smartwatch and mobile app (myBPmyLife) help people with high blood pressure increase physical activity and reduce salt intake. Participants will be randomly assigned to either receive these interventions through the app or placed in a control group without such features.

Participant Groups

Group I: Dietary plus physical activity JITAI Experimental Treatment 1 Intervention

Participants in the experimental group will be provided a smarthwatch and home blood pressure monitor. They will then receive the myBPmyLife app that includes push notifications to promote increased physical activity and improve low sodium food choices. The app also provides goal setting for weekly step count and information on low-sodium food choices, as well as feedback on achieving the goals using a dashboard with visualization tools within the mobile application.

Group II: Control arm Experimental Treatment 1 Intervention

Participants in the control group will be provided a smartwatch and home blood pressure monitor. They will also be provided with general instructions on how to download and install a physical activity and diet regulation applications (apps) available to the general public. They will still be asked to perform the blood pressure monitoring at regularly scheduled time periods, but do not receive the intervention components notifications in myBPmyLife app developed for the experimental group.

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

Marschall S. Runge

University of Michigan

Chief Executive Officer since 2015

MD, PhD

Karen McConnell

University of Michigan

Chief Medical Officer since 2020

MD

American Heart Association

Collaborator

Trials

352

Recruited

6,196,000+

Eduardo Sanchez

American Heart Association

Chief Medical Officer since 2013

MD from University of Texas Southwestern Medical School, MPH from UT Health Science Center at Houston, MS in Biomedical Engineering from Duke University

Katrina McGhee

American Heart Association

Chief Executive Officer since 2020

MBA from the University of Texas at Arlington