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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01HL127215-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Wayne State University | OTHER |
| Vanderbilt University | OTHER |
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual care | No Intervention | 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. | |
| MI-BP | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MI-BP | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in mean systolic blood pressure | from baseline to 1 year |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Cost-effectiveness of MI-BP compared to usual care | within-trial | |
| Cost-effectiveness of MI-BP compared to usual care | long-term |
Inclusion Criteria:
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:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Lorraine R Buis, PhD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48104 | United States | ||
| Wayne State University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38941601 | Derived | Buis LR, Kim J, Sen A, Chen D, Dawood K, Kadri R, Muladore R, Plegue M, Richardson CR, Djuric Z, McNaughton C, Hutton D, Robert LP, Park SY, Levy P. The Effect of an mHealth Self-Monitoring Intervention (MI-BP) on Blood Pressure Among Black Individuals With Uncontrolled Hypertension: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2024 Jun 28;12:e57863. doi: 10.2196/57863. |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| 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 |
| Detroit |
| Michigan |
| 48202 |
| United States |