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mHealth App for High Blood Pressure (myBPmyLife Trial)

N/A

Waitlist Available

Led By Brahmajee K Nallamothu, MD

Research Sponsored by University of Michigan

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 6 months

Awards & highlights

myBPmyLife Trial Summary

This trial will determine whether a smartwatch and a mobile health application can increase activity levels and reduce salt intake for people with high blood pressure.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Since this trial involves lifestyle changes delivered via an app rather than medication, side effects may include discomfort from increased physical activity or dietary adjustments but no medicinal side effects are expected.

myBPmyLife Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in systolic blood pressure between baseline and 6-months

Secondary outcome measures

Change in diastolic blood pressure from baseline to 6-months (i.e., 180 days)

Change in mean daily sodium intake between baseline and 6-months (Block Sodium Screener)

Change in mean daily step count between baseline and 6-months (i.e., 180 days)

+5 more

myBPmyLife Trial Design

2Treatment groups

Experimental Treatment

Group I: Dietary plus physical activity JITAIExperimental Treatment1 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 armExperimental Treatment1 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dietary and physical activity JITAI delivered through the myBPmyLife app

2021

N/A

~610

Do I qualify?Apply below to find out

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Who is running the clinical trial?

University of MichiganLead Sponsor

1,795 Previous Clinical Trials

6,373,328 Total Patients Enrolled

American Heart AssociationOTHER

324 Previous Clinical Trials

4,933,170 Total Patients Enrolled

Brahmajee K Nallamothu, MDPrincipal InvestigatorUniversity of Michigan

Media Library

High Blood Pressure Research Study Groups: Control arm, Dietary plus physical activity JITAI

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available slots in this research program?

"clinicaltrials.gov states that the recruitment process for this trial is no longer in effect, as it was initially posted on December 21st 2021 and last updated on May 17th 2022. In spite of this, 745 other clinical trials are actively recruiting patients at present."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Improving Blood Pressure Control Through the myBPmyLife mHealth Application

Brahmajee K Nallamothu 2021. "Improving Blood Pressure Control Through the myBPmyLife mHealth Application". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05154929.