MI-BP: mHealth to Improve Blood Pressure Control

NCT ID: NCT02955537

Last Updated: 2023-03-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 162 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-11
• Study Completion Date: 2021-04-15

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Usual care

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

MI-BP

Intervention Type: 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.

Interventions

MI-BP

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wayne State University

OTHER

Sponsor Role: collaborator

Vanderbilt University

OTHER

Sponsor Role: collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Lorraine Buis

Associate Professor of Family Medicine, Medical School and Associate Professor of Information, School of Information

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lorraine R Buis, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

University of Michigan

Ann Arbor, Michigan, United States

Wayne State University

Detroit, Michigan, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 38941601 (View on PubMed)

Other Identifiers

1R01HL127215-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HUM00114202

Identifier Type: -

Identifier Source: org_study_id