MI-BP: mHealth to Improve Blood Pressure Control

University of Michigan2 sites in 1 country162 target enrollmentJanuary 11, 2018

ConditionsHypertension

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Hypertension
Sponsor: University of Michigan
Enrollment: 162
Locations: 2
Primary Endpoint: Change in mean systolic blood pressure
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 11, 2018

End Date

April 15, 2021

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University of Michigan

Responsible Party

Principal Investigator

Lorraine Buis

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

University of Michigan

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

Outcomes

Primary Outcomes

Change in mean systolic blood pressure

Time Frame: from baseline to 1 year

Secondary Outcomes

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)