Improving Blood Pressure Control Through the myBPmyLife mHealth Application

University of Michigan

Status: Completed

Conditions: Hypertension

Treatments: Other: Control Group; Behavioral: Dietary and physical activity JITAI delivered through the myBPmyLife app

Study type: Interventional

Funder types: Other

Identifiers

NCT05154929

HUM00205845

Details and patient eligibility

About

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.

Enrollment: 608 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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608 participants in 2 patient groups

Control arm

Other group

Description:

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:

Other: Control Group

Dietary plus physical activity JITAI

Experimental group

Description:

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.

Treatment:

Behavioral: Dietary and physical activity JITAI delivered through the myBPmyLife app