MI-BP: mHealth to Improve Blood Pressure Control

Study Overview
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Brief Summary
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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.

Official Title
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MI-BP: mHealth to Improve Blood Pressure Control

Conditions
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Hypertension

Intervention / Treatment
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* Other: MI-BP


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Usual care<br>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. | |
| Experimental: MI-BP<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in mean systolic blood pressure |  | from baseline to 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypertension, mHealth