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| Name | Class |
|---|---|
| Miami Heart Research Institute Inc. | UNKNOWN |
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The purpose of this study is to test the hypertension (HTN) app-based intervention to see if it is more effective in improving uncontrolled HTN and HTN self-care among Africian-Americans from baseline to post-intervention (immediate, 3 months and 6 months post-intervention) as compared to the standard of care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group | Experimental | African American adults with uncontrolled hypertension (HTN) will be assigned to complete an 11 week guided intervention using the FAITH! HTN app. |
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| Control Group | No Intervention | African American adults with uncontrolled hypertension (HTN) will receive the standard of care of HTN management. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FAITH! HTN app | Behavioral | Participants will remain in the intervention for 11 weeks. The app-based intervention is a tailored program to promote HTN self-management and knowledge through an 11-module educational video series with a focus on HTN. Participants will also be provided with at home Blood Pressure (BP) monitoring system to allow for self-tracking of BP measurements(automatically synchronized with the app). The app will include pre-post module quizzes, a tracking component for participants to input self-monitored measures (medication adherence, diet, physical activity, etc.). The app sharing board will be a moderated discussion platform and feed for participant interaction by posting healthy lifestyle practices through text, photographs and video to foster discussion on HTN management barriers/facilitators. The project team will post weekly to the sharing board on HTN-related topics to generate discussion among patients. |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute Change in Systolic Blood Pressure (BP) | Systolic BP (mmHg) will be measured as an average of 3 sitting readings with an oscillometric automated device during in-clinic health assessments. | Baseline, immediate post intervention |
| HTN Self-Care as reported by H-SCALE(HTN Self-Care Activity Level Effects) | The H-SCALE is a 31-item instrument that assesses 6 HTN behavioral self-care activities recommended for optimal HTN management (BP medication adherence, weight loss/ideal body weight maintenance, adoption of a low-salt diet, regular physical activity for ≥30 minutes/day, limiting alcohol intake, and ceasing tobacco use). | Baseline, immediate, 3 months, 6 months post intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects reaching BP control | Proportion of subjects reaching BP control (defined as meeting target BP of <140/90 mmHg) | Immediate, 3 months, 6 months post intervention |
| Change in BP as assessed by home BP cuff measurements |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lainey Moen | Contact | 507-266-7062 | Moen.Lainey@mayo.edu | |
| Ashton Krogman | Contact | 507-266-2087 | Krogman.Ashton@mayo.edu |
| Name | Affiliation | Role |
|---|---|---|
| LaPrincess Brewer, M.D., M.P.H | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Recruiting | Rochester | Minnesota | 55905 | United States |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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BP (mmHg) will be measured 3 times per week during the 11-week intervention period using a home BP monitoring system. The 3 weekly measurements will be averaged and average weekly BP will be compared from baseline to immediate post intervention to determine the change in BP. This outcome is only evaluated in the intervention group as the control group will not undergo home BP cuff measurements.
| Baseline, immediate post intervention |
| CV Health Knowledge as measured by module assessment scores | Change in percentage correct scores (pre- and post- self-assessments) for each education module by patient and as a conglomerate (mean) for all patients. | Immediate post intervention |
| Hypertension (HTN) Knowledge as assessed by 11-item questionnaire | HTN Knowledge will be assessed using a previously validated 11-item questionnaire which asks participants questions about the definition, prevention, management and complications of hypertension. Responses are record as true, false or uncertain to each question with true response receiving a score of 1 and false or uncertain responses receiving a score of 0. Total scores on the questionnaire range from 0-11 with higher scores reflecting better HTN knowledge. | Baseline, immediate post intervention |