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OpenTrials
Completed

NCT Number: NCT02955537

MI-BP: mHealth to Improve Blood Pressure Control

This study seeks to evaluate a multicomponent mobile intervention to change multiple hypertension-related health behaviors in minorities and the underserved with uncontrolled hypertension. Half of the participants will receive a mobile intervention designed to improve physical activity, sodium intake, and medication adherence. The other half will receive usual care.

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Key information

Age range

25 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan, Ann Arbor, Michigan, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Detroit-area residents
  • Hypertensive
  • Owning a compatible smartphone
  • Presenting to the Detroit Medical Center Detroit Receiving, Sinai-Grace Hospital, or selected Community Health Screening Events with, but not necessarily for, uncontrolled blood pressure (systolic blood pressure ≥ 135 mm Hg at triage and on repeat measurement using the BpTRU device).

Exclusion criteria

  • No self-reported prior history of hypertension
  • No hypertension diagnosis documented in their medical record
  • Non-English speaking
  • Presenting with an acute illness necessitating immediate medical intervention
  • Presenting with an admission to the hospital for critical reasons (as determined by the attending physician)
  • Pregnant (as determined by a dip test at screening), or self-report during trial.
  • Having the following serious comorbidities or confounders due to the fact that they may make blood pressure control difficult or necessitate frequent Emergency Department use or hospitalization:
  • Previous diagnosis of resistant hypertension (or current use of 3 or more maximally dosed antihypertensive agents without achievement of blood pressure control)
  • Steroid dependent asthma or emphysema
  • Cirrhosis or hepatic failure
  • Chronic heart failure (any stage)
  • Previous diagnosis of acute myocardial infarction, angina (stable or unstable), or known coronary artery disease
  • Previous diagnosis of cerebrovascular disease (including transient ischemic attack or stroke)
  • Known valvular heart disease
  • Stage IV or V chronic kidney disease
  • Cancer (terminal or undergoing active chemotherapeutic or radiation therapy)
  • Patients with other serious medical conditions that may affect their ability to self-monitor blood pressure (such a dementia)
  • Having a history of alcohol or drug abuse as determined by the CAGE-AID questionnaire (excluded if 2 or more)
  • Week 2 measurement of systolic blood pressure < 130 mm Hg using the BpTRU device or study-issued BP cuff.

Treatment and study plan

MI-BP

Other

MI-BP includes the following components: 1) Home blood pressure monitoring 2) Physical activity monitoring 3) Sodium intake self-monitoring 4) Physical activity and sodium intake goal setting 5) Educational messaging via push notification and in-app messaging 6) motivational messaging 7) tailored messaging relevant to individual participants and 8) medication reminders.

Primary outcomes

  1. Change in mean systolic blood pressure

    Time frame: from baseline to 1 year

Secondary outcomes

  1. Change in physical activity as measured by the International Physical Activity Questionnaire (IPAQ-SF)

    Time frame: from baseline to 1 year

  2. Change in sodium intake as measured by the Block Sodium Screener

    Time frame: from baseline to 1 year

  3. Change in medication adherence as measured by Adherence to Refills and Medications Scale (ARMS)

    Time frame: from baseline to 1 year

  4. Change in blood pressure control

    Time frame: from baseline to 1 year

Other outcomes

  1. Cost-effectiveness of MI-BP compared to usual care

    Time frame: within-trial

  2. Cost-effectiveness of MI-BP compared to usual care

    Time frame: long-term

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)
  • Vanderbilt University
  • Wayne State University

Registry information

Acronym: MI-BP

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Nov 4, 2016
Registry last updated
Mar 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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