MI-BP: mHealth to Improve Blood Pressure Control

Not Applicable

Completed

• Conditions: Hypertension
• Interventions: Other: MI-BP

• Registration Number: NCT02955537
• Lead Sponsor: University of Michigan

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-11-02
• Study First Submitted QC: 2016-11-02
• Study First Posted: 2016-11-04
• Study Start: 2018-01-11
• Primary Completion: 2021-04-15
• Study Completion: 2021-04-15
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-27
• Last Update Posted: 2023-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 162

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).

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MI-BP	MI-BP	MI-BP participants will receive an antihypertensive medication prescription, and be asked to use technology-mediated devices/services linked to positive changes in target behavior/outcome including the MI-BP app, a secure, mHealth platform that will be installed on participant smartphones.

Primary Outcome Measures

Name	Time	Method
Change in mean systolic blood pressure	from baseline to 1 year

Secondary Outcome Measures

Name	Time	Method
Change in physical activity as measured by the International Physical Activity Questionnaire (IPAQ-SF)	from baseline to 1 year
Change in sodium intake as measured by the Block Sodium Screener	from baseline to 1 year
Change in medication adherence as measured by Adherence to Refills and Medications Scale (ARMS)	from baseline to 1 year
Change in blood pressure control	from baseline to 1 year

Trial Locations

Locations (2)

Wayne State University; 🇺🇸 Detroit, Michigan, United States

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States