MI-BP: mHealth to Improve Blood Pressure Control

University of Michigan

Status: Completed

Conditions: Hypertension

Treatments: Other: MI-BP

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02955537

1R01HL127215-01A1

HUM00114202 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 162 patients

Sex: All

Ages: 25 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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162 participants in 2 patient groups

Usual care

No Intervention group

Description:

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 group

Description:

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.

Treatment:

Other: MI-BP