Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

MI-BP: mHealth to Improve Blood Pressure Control (MI-BP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02955537
Recruitment Status : Recruiting
First Posted : November 4, 2016
Last Update Posted : July 6, 2021
Sponsor:
Collaborators:
Wayne State University
Vanderbilt University
Information provided by (Responsible Party):
Lorraine Buis, University of Michigan

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Hypertension Other: MI-BP Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 304 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: MI-BP: mHealth to Improve Blood Pressure Control
Actual Study Start Date : January 11, 2018
Estimated Primary Completion Date : January 2023
Estimated Study Completion Date : June 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
No Intervention: 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.
Experimental: 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.
 Other: 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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Change in mean systolic blood pressure [ Time Frame: from baseline to 1 year ]

Secondary Outcome Measures :
  1. Change in physical activity as measured by the International Physical Activity Questionnaire (IPAQ-SF) [ Time Frame: from baseline to 1 year ]
  2. Change in sodium intake as measured by the Block Sodium Screener [ Time Frame: from baseline to 1 year ]
  3. Change in medication adherence as measured by Adherence to Refills and Medications Scale (ARMS) [ Time Frame: from baseline to 1 year ]
  4. Change in blood pressure control [ Time Frame: from baseline to 1 year ]

Other Outcome Measures:
  1. Cost-effectiveness of MI-BP compared to usual care [ Time Frame: within-trial ]
  2. Cost-effectiveness of MI-BP compared to usual care [ Time Frame: long-term ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   25 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02955537


Contacts
Layout table for location contacts
Contact: Reema Kadri, MLIS 734-998-7120 ext 312 rkadri@med.umich.edu

Locations
Layout table for location information
United States, Michigan
University of Michigan Active, not recruiting
Ann Arbor, Michigan, United States, 48104
Wayne State University Recruiting
Detroit, Michigan, United States, 48202
Contact: Katee Dawood         
Principal Investigator: Phillip Levy, MD, MPH         
Sponsors and Collaborators
University of Michigan
Wayne State University
Vanderbilt University
Investigators
Layout table for investigator information
Principal Investigator: Lorraine R Buis, PhD University of Michigan
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Lorraine Buis, Assistant Professor of Family Medicine, Medical School and Assistant Professor of Information, School of Information, University of Michigan
ClinicalTrials.gov Identifier: NCT02955537    
Other Study ID Numbers: 1R01HL127215-01A1 ( U.S. NIH Grant/Contract )
HUM00114202 ( Other Identifier: University of Michigan )
First Posted: November 4, 2016    Key Record Dates
Last Update Posted: July 6, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lorraine Buis, University of Michigan:
Hypertension
mHealth
Additional relevant MeSH terms:
Layout table for MeSH terms
Hypertension
Vascular Diseases
Cardiovascular Diseases