MI-BP: mHealth to Improve Blood Pressure Control

NCT02955537 | Completed DMC

• 2 other identifiers: HUM001142021R01HL127215-01A1
• Study Type: interventional
• Target: 162
• Locations: 1 country
• Sites: 2

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.

Conditions

Hypertension

Keywords

Hypertension; mHealth

Outcome Measures

Primary Outcomes (1)

• Change in mean systolic blood pressure

  from baseline to 1 year

Secondary Outcomes (4)

• 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

Other Outcomes (2)

• Cost-effectiveness of MI-BP compared to usual care

  within-trial

• Cost-effectiveness of MI-BP compared to usual care

  long-term

Study Arms (2)

Usual care

NO INTERVENTION

Usual care participants will be given a prescription for antihypertensive medications, printed educational materials on hypertension, and a home blood pressure monitor for daily use, but will receive no further intervention.

MI-BP

EXPERIMENTAL

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.

Other: MI-BP

Interventions

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.

MI-BP

Eligibility Criteria

• Age: 25 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead
• Wayne State University: collaborator
• Vanderbilt University: collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (2)

University of Michigan

Ann Arbor, Michigan, 48104, United States

Location

Wayne State University

Detroit, Michigan, 48202, United States

Location

Related Publications (1)

• Buis LR, Kim J, Sen A, Chen D, Dawood K, Kadri R, Muladore R, Plegue M, Richardson CR, Djuric Z, McNaughton C, Hutton D, Robert LP, Park SY, Levy P. The Effect of an mHealth Self-Monitoring Intervention (MI-BP) on Blood Pressure Among Black Individuals With Uncontrolled Hypertension: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2024 Jun 28;12:e57863. doi: 10.2196/57863.

  PMID: 38941601 DERIVED

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Lorraine R Buis, PhD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Family Medicine, Medical School and Associate Professor of Information, School of Information

Study Record Dates

• First Submitted: November 2, 2016
• First Posted: November 4, 2016
• Study Start: January 11, 2018
• Primary Completion: April 15, 2021
• Study Completion: April 15, 2021
• Last Updated: March 1, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)