Clinical trial NCT05154929: Improving Blood Pressure Control Through the myBPmyLife mHealth Application
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
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Keywords: high blood pressure
exercise
decrease salty food
smartwatch
mobile application
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: American Heart Association
First posted: 2021-12-13
Enrollment: 608
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in systolic blood pressure between baseline and 6-months
timeFrame: Baseline, 6 months
Secondary outcomes:
measure: Number of self-reported low-sodium food choices within 24 hours of a diet notification
timeFrame: within 24 hours of a diet notification
measure: Number of steps taken within 60 minutes of a physical activity notification
timeFrame: within 60 minutes of a physical activity notification
measure: Change in mean daily sodium intake between baseline and 6-months (Block Sodium Screener)
timeFrame: Baseline, up to 6 months
measure: Change in mean daily step count between baseline and 6-months (i.e., 180 days)
timeFrame: Baseline, up to 6 months
measure: Change in diastolic blood pressure from baseline to 6-months (i.e., 180 days)
timeFrame: Baseline, up to 6 months
measure: Trends in weekly systolic BP over the 6-months (i.e., 180 days)
timeFrame: Baseline to weekly assessments that are available up to 24 weeks
measure: Changes in systolic BP from baseline to 60 days, 120 days, and at 180 days (i.e., approximately 2 months)
timeFrame: Baseline, every 60 days from 0 days to 60 days to 120 days to 180 days (i.e., approximately 2 months)
measure: Change in quality-of-life between baseline and 6-months as assessed by the single-item Self-Rated Health (SRH) Questionnaire
timeFrame: Baseline, up to 6 months
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Flint
country: United States
facility: Hamilton Community Health Network
state: Michigan
Study officials:
affiliation: University of Michigan
name: Brahmajee K Nallamothu, MD
role: PRINCIPAL_INVESTIGATOR
References: