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
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hypertension | Other: MI-BP | Not Applicable |
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 |

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. |
- Change in mean systolic blood pressure [ Time Frame: from baseline to 1 year ]
- Change in physical activity as measured by the International Physical Activity Questionnaire (IPAQ-SF) [ Time Frame: from baseline to 1 year ]
- Change in sodium intake as measured by the Block Sodium Screener [ Time Frame: from baseline to 1 year ]
- Change in medication adherence as measured by Adherence to Refills and Medications Scale (ARMS) [ Time Frame: from baseline to 1 year ]
- Change in blood pressure control [ Time Frame: from baseline to 1 year ]
- Cost-effectiveness of MI-BP compared to usual care [ Time Frame: within-trial ]
- Cost-effectiveness of MI-BP compared to usual care [ Time Frame: long-term ]

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.
Ages Eligible for Study: | 25 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

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
Contact: Reema Kadri, MLIS | 734-998-7120 ext 312 | rkadri@med.umich.edu |
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 |
Principal Investigator: | Lorraine R Buis, PhD | University of Michigan |
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Hypertension mHealth |
Hypertension Vascular Diseases Cardiovascular Diseases |