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Improving Blood Pressure Control Through the myBPmyLife mHealth Application (myBPmyLife)

Primary Purpose

Hypertension

Status

Active

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Dietary and physical activity JITAI delivered through the myBPmyLife app

Control Group

About this trial

This is an interventional treatment trial for Hypertension focused on measuring high blood pressure, exercise, decrease salty food, smartwatch, mobile application

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

University of Michigan
Hamilton Community Health Network

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

Control arm

Dietary plus physical activity JITAI

Arm 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.

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.

Outcomes

Primary Outcome Measures

Change in systolic blood pressure between baseline and 6-months

Secondary Outcome Measures

Number of self-reported low-sodium food choices within 24 hours of a diet notification

Number of steps taken within 60 minutes of a physical activity notification

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)

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

Trends in weekly systolic BP over the 6-months (i.e., 180 days)

Changes in systolic BP from baseline to 60 days, 120 days, and at 180 days (i.e., approximately 2 months)

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.

Full Information

NCT ID

NCT05154929

First Posted

November 30, 2021

Last Updated

July 11, 2023

Sponsor

University of Michigan

Collaborators

American Heart Association

1. Study Identification

Unique Protocol Identification Number

NCT05154929

Brief Title

Improving Blood Pressure Control Through the myBPmyLife mHealth Application

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

December 21, 2021 (Actual)

Primary Completion Date

January 29, 2024 (Anticipated)

Study Completion Date

January 29, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Michigan

Collaborators

American Heart Association

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypertension

Keywords

high blood pressure, exercise, decrease salty food, smartwatch, mobile application

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

This study is a multicenter 6 month randomized controlled clinical trial. This study will investigate the efficacy of two just-in-time adaptive interventions (JITAIs) delivered via a mobile app for patients with hypertension. Eligible participants will be randomized to the two JITAIs or control in a 1:1 manner stratified by site. There will be two sites: the University of Michigan Health System in Ann Arbor and the Hamilton Community Health Network Clinic in Flint.

Masking

None (Open Label)

Allocation

Randomized

Enrollment

608 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Control arm

Arm Type

Other

Arm Description

Arm Title

Dietary plus physical activity JITAI

Arm Type

Experimental

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Dietary and physical activity JITAI delivered through the myBPmyLife app

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Control Group

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change in systolic blood pressure between baseline and 6-months

Time Frame

Baseline, 6 months

Secondary Outcome Measure Information:

Title

Number of self-reported low-sodium food choices within 24 hours of a diet notification

Time Frame

within 24 hours of a diet notification

Title

Number of steps taken within 60 minutes of a physical activity notification

Time Frame

within 60 minutes of a physical activity notification

Title

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

Time Frame

Baseline, up to 6 months

Title

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

Time Frame

Baseline, up to 6 months

Title

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

Time Frame

Baseline, up to 6 months

Title

Trends in weekly systolic BP over the 6-months (i.e., 180 days)

Time Frame

Baseline to weekly assessments that are available up to 24 weeks

Title

Changes in systolic BP from baseline to 60 days, 120 days, and at 180 days (i.e., approximately 2 months)

Time Frame

Baseline, every 60 days from 0 days to 60 days to 120 days to 180 days (i.e., approximately 2 months)

Title

Change in quality-of-life between baseline and 6-months as assessed by the single-item Self-Rated Health (SRH) Questionnaire

Description

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.

Time Frame

Baseline, up to 6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Brahmajee K Nallamothu, MD

Organizational Affiliation

University of Michigan

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Michigan

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48109

Country

United States

Facility Name

Hamilton Community Health Network

City

Flint

State/Province

Michigan

ZIP/Postal Code

48505

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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Improving Blood Pressure Control Through the myBPmyLife mHealth Application

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