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NCT05154929Completed

Improving Blood Pressure Control Through the myBPmyLife mHealth Application

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

Source: ClinicalTrials.gov · Last updated 20 Feb 2024

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Interventional
Enrollment
608 (actual)
First submitted
30 Nov 2021
Start date
21 Dec 2021
Primary completion date
27 Jan 2024
Lead sponsor
University of Michigan
NCT number
NCT05154929

What you commit to

  • Study type: Interventional
  • Participants enrolled: 608
  • From 21 Dec 2021 to the primary completion date, 27 Jan 2024
  • 2 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • 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

Lab values

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

Other

  • Unstable symptoms or markedly elevated BP at enrollment (defined as systolic BP\>180 mmHg, diastolic BP\>120 millimeters of mercury (mmHg))
  • Wrist too large to wear a smartwatch comfortably.
  • Currently pregnant or planning to become pregnant in the next six months

Who the study is looking for

  • 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.)

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University of Michigan
Coordinator of this site? Confirm its status
Ann ArborUnited StatesUnknown status
Hamilton Community Health Network
Coordinator of this site? Confirm its status
FlintUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.