Clinical trial NCT02955537: MI-BP: mHealth to Improve Blood Pressure Control
Official title: MI-BP: mHealth to Improve Blood Pressure Control
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Keywords: Hypertension
mHealth
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Wayne State University
name: Vanderbilt University
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2016-11-04
Enrollment: 162
Sex: ALL
Minimum age (years): 25
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Change in mean systolic blood pressure
timeFrame: from baseline to 1 year
Secondary outcomes:
measure: Change in physical activity as measured by the International Physical Activity Questionnaire (IPAQ-SF)
timeFrame: from baseline to 1 year
measure: Change in sodium intake as measured by the Block Sodium Screener
timeFrame: from baseline to 1 year
measure: Change in medication adherence as measured by Adherence to Refills and Medications Scale (ARMS)
timeFrame: from baseline to 1 year
measure: Change in blood pressure control
timeFrame: from baseline to 1 year
Other outcomes:
measure: Cost-effectiveness of MI-BP compared to usual care
timeFrame: within-trial
measure: Cost-effectiveness of MI-BP compared to usual care
timeFrame: long-term
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Detroit
country: United States
facility: Wayne State University
state: Michigan
Study officials:
affiliation: University of Michigan
name: Lorraine R Buis, PhD
role: PRINCIPAL_INVESTIGATOR
References: