Improving Blood Pressure Control Through the myBPmyLife mHealth Application

Hypertension Clinical Trial

— myBPmyLife  

Official title:

Improving Blood Pressure Control Through the myBPmyLife mHealth Application: A Wearables in Reducing Risk and Enhancing Daily Lifestyle (WIRED-L) Center Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05154929
• Other study ID #: HUM00205845
• Status: Completed
• Phase: N/A
• Start date: December 21, 2021
• Est. completion date: January 27, 2024

Study information

• Verified date: February 2024
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is enrolling eligible participants that have high blood pressure. Reducing dietary salt intake and engaging in regular physical activity is known to decrease blood pressure in people with hypertension. This trial will determine whether a smartwatch and a mobile health application, which together deliver notifications, can increase activity levels and reduce salt intake for people with high blood pressure. All study activities will be completed online or via a mobile medical application. Participants will not have any face-to-face visits with the study team.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 608
• Est. completion date: January 27, 2024
• Est. primary completion date: January 27, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Self-reported history of hypertension and no hypertensive medication changes in the last 4 weeks.

• A smartphone with a compatible Apple or Android operating system installed and able to download and use the myBPmyLife app including accepting all permissions

• A valid email address

• Fluent in spoken and written English

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

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.

• Unstable symptoms or markedly elevated BP at enrollment (defined as systolic BP>180 mmHg, diastolic BP>120 millimeters of mercury (mmHg))

• Known secondary causes of hypertension (e.g., adrenal insufficiency, pheochromocytoma), heart failure, or end-stage renal disease

• Difficulty using an upper arm blood pressure cuff due to biceps size or end-stage renal disease or difficulty comfortably wearing a smartwatch

• Wrist too large to wear a smartwatch comfortably.

• Daily sodium intake less than 1500 mg/day as measured by the sodium screener

• Currently pregnant or planning to become pregnant in the next six months

Related Conditions & MeSH terms

• Hypertension

Intervention

Behavioral:
• Dietary and physical activity JITAI delivered through the myBPmyLife app
A Fitbit smartwatch and home blood pressure monitor will be mailed to participants (in both the experimental and control arms). Participants in the intervention arm then will set up and utilize the myBPmyLife app. This app includes push notifications to promote increased physical activity and improve low-sodium food choices, establish goal setting for weekly step count and low sodium food choices, and deliver feedback on achieving the goals using a dashboard visualization within the mobile application.

Other:
• Control Group
Participants will receive the myBPmyLife app, a smartwatch, and blood pressure cuff. The myBPmyLife app will not be fully activated (as they are in the control arm). They will be provided with the option of downloading and installing a mHealth app that is publicly available. In this arm they will also perform the blood pressure monitoring, but do not receive the intervention components through the myBPmyLife app.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	Hamilton Community Health Network	Flint	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	American Heart Association

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in systolic blood pressure between baseline and 6-months		Baseline, 6 months
Secondary	Number of self-reported low-sodium food choices within 24 hours of a diet notification		within 24 hours of a diet notification
Secondary	Number of steps taken within 60 minutes of a physical activity notification		within 60 minutes of a physical activity notification
Secondary	Change in mean daily sodium intake between baseline and 6-months (Block Sodium Screener)		Baseline, up to 6 months
Secondary	Change in mean daily step count between baseline and 6-months (i.e., 180 days)		Baseline, up to 6 months
Secondary	Change in diastolic blood pressure from baseline to 6-months (i.e., 180 days)		Baseline, up to 6 months
Secondary	Trends in weekly systolic BP over the 6-months (i.e., 180 days)		Baseline to weekly assessments that are available up to 24 weeks
Secondary	Changes in systolic BP from baseline to 60 days, 120 days, and at 180 days (i.e., approximately 2 months)		Baseline, every 60 days from 0 days to 60 days to 120 days to 180 days (i.e., approximately 2 months)
Secondary	Change in quality-of-life between baseline and 6-months as assessed by the single-item Self-Rated Health (SRH) Questionnaire	Change in the proportion of SRH responses from baseline to 6-months (i.e., 180 days) across 2 categories: 1) excellent, very good or good versus 2) fair or poor.	Baseline, up to 6 months