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The project objective is to test the feasibility of delivering health education and self-management support to African-American patients with uncontrolled hypertension (HTN) through a culturally-tailored smartphone application (app)-enhanced intervention within federally qualified health centers.
The Fostering African-American Improvement in Total Health (FAITH!) Program at Mayo Clinic, a community-based cardiovascular (CV) health promotion initiative for African-Americans (AAs) will collaborate with the Minnesota Department of Health (MDH) Cardiovascular Health Unit and two federally qualified health centers (FQHCs) (NorthPoint Health & Wellness Center, Minneapolis, MN; Open Cities Health Center, St. Paul, MN) to integrate an innovative mobile health (mHealth) intervention (FAITH! HTN App) into clinical and community settings with the aim of improving blood pressure (BP) control.
The project objective is to test the feasibility of delivering health education and self-management support to African-American patients with uncontrolled hypertension (HTN) through a culturally-tailored smartphone application (app)-enhanced intervention within federally qualified health centers. This initiative is a component of a Centers for Disease Control and Prevention (CDC) effort to support state/local public health strategies to prevent and manage cardiovascular disease (CVD) in under-resourced populations disproportionately affected by CVD risk factors, such as HTN. Insights from the FAITH! Community Steering Committee (CSC) will also provide guidance to ensure project patient-centeredness. The investigators will incorporate strategies grounded in theoretical frameworks to ensure soundness of our intervention while tailoring it to meet the preferences and needs of an under-resourced population with multi-level barriers to HTN management.
Specific Aim 1:To assess app feasibility through participant intervention engagement (app education module completion, self-monitoring) and intervention satisfaction.
Specific Aim 2: To assess preliminary efficacy of the app by evaluating improvement in patient BP control (immediate, 3 months and 6 months post-intervention), CV health knowledge (via app self-assessments), and BP self-management (medication adherence).
Hypothesis:
The study hypothesis is that an app-based intervention will be feasible and demonstrate preliminary efficacy in improving uncontrolled HTN and health education among AA patients from baseline to post-intervention (immediate, 3 months and 6 months post-intervention).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FAITH! App-enhanced Hypertension Intervention | Experimental | FAITH! HTN App: The program promotes HTN self-management through a 10-week education module series on HTN. Participants will follow each module weekly and use a wireless home BP monitor for self-tracking which syncs to the app. The app includes module quizzes, a BP tracking dashboard and a moderated sharing board to foster discussion on HTN management. Patient-Provider-CHW ICM. The patient-provider-CHW triad works together for personalized, collaborative goal setting. The patient will complete app modules, self-monitor BP, and engage with a sharing board integrating HTN topics. At weekly virtual visits (telephone or video), the CHW will record patient BPs, assist with addressing social determinants of health (SDOH) identified by the patient (eg, local community resources), and review HTN modules. The CHW will upload clinical/SDOH data to the patient electronic medical record (EMR) for FQHC care providers to review. This cycle will be completed weekly over the 10-week intervention. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FAITH! App-enhanced Hypertension Intervention | Behavioral | FAITH! HTN App: The program promotes HTN self-management through a 10-week education module series on HTN. Participants will follow each module weekly and use a wireless home BP monitor for self-tracking which syncs to the app. The app includes module quizzes, a BP tracking dashboard and a moderated sharing board to foster discussion on HTN management. Patient-Provider-CHW ICM. The patient-provider-CHW triad works together for personalized, collaborative goal setting. The patient will complete app modules, self-monitor BP, and engage with a sharing board integrating HTN topics. At weekly virtual visits (telephone or video), the CHW will record patient BPs, assist with addressing social determinants of health (SDOH) identified by the patient (eg, local community resources), and review HTN modules. The CHW will upload clinical/SDOH data to the patient electronic medical record (EMR) for FQHC care providers to review. This cycle will be completed weekly over the 10-week intervention. |
| Measure | Description | Time Frame |
|---|---|---|
| Blood pressure (systolic and diastolic, mmHg) | Change from baseline blood pressure. | 0 months post intervention |
| Blood pressure (systolic and diastolic, mmHg) | Change from baseline blood pressure. | 3 months post intervention |
| Blood pressure (systolic and diastolic, mmHg) | Change from baseline blood pressure. | 6 months post intervention |
| Intervention Feasibility Measures - Participant Engagement with Self-Monitoring | Participant engagement with weekly blood pressure tracking measured by number of times participant engaged with the blood pressure feature | Immediate post-intervention |
| Intervention Feasibility Measures - Participant Engagement with Self-Monitoring | Participant engagement with weekly blood pressure tracking measured by number of times participant engaged with the blood pressure feature | Time Frame: 3 months post-intervention |
| Intervention Feasibility Measures - Participant Engagement with Self-Monitoring | Participant engagement with weekly blood pressure tracking measured by number of times participant engaged with the blood pressure feature | Time Frame: 6 months post-intervention |
| HTN Self-Care Measures - Participant HTN self-care activities using the H-SCALE (Hypertension Self-Care Activity Level Effects) |
| Measure | Description | Time Frame |
|---|---|---|
| Preliminary Efficacy of 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 |
| Social Determinants of Health (SDOH, PRAPARE (Protocol for Responding to and Addressing Patient Assets, Risks, and Experiences) tool) |
| Measure | Description | Time Frame |
|---|---|---|
| Intervention Feasibility Measures - Participant Engagement with Sharing Board | Participant engagement with sharing board measured by number of posts per week by each participant | Immediate post-intervention |
| Intervention Feasibility Measures - Participant Engagement with Sharing Board |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| LaPrincess C Brewer, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| North Point Health & Wellness Center | Minneapolis | Minnesota | 55411 | United States | ||
| Mayo Clinic |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37115658 | Derived | Brewer LC, Jones C, Slusser JP, Pasha M, Lalika M, Chacon M, Takawira P, Shanedling S, Erickson P, Woods C, Krogman A, Ferdinand D, Underwood P, Cooper LA, Patten CA, Hayes SN. mHealth Intervention for Promoting Hypertension Self-management Among African American Patients Receiving Care at a Community Health Center: Formative Evaluation of the FAITH! Hypertension App. JMIR Form Res. 2023 Jun 16;7:e45061. doi: 10.2196/45061. |
| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jul 1, 2021 | Aug 3, 2021 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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This is a nonrandomized, single arm feasibility study testing the preliminary efficacy of an app-enhanced intervention with a patient-provider-community health worker triad to promote hypertension control among AA patients within FQHCs.
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The 31-item instrument assess 6 HTN behavioral self-care activities recommended for optimal HTN management
| Immediate post-intervention |
| HTN Self-Care Measures - Participant HTN self-care activities using the H-SCALE (Hypertension Self-Care Activity Level Effects) | The 31-item instrument assess 6 HTN behavioral self-care activities recommended for optimal HTN management | 3 months post-intervention |
| HTN Self-Care Measures - Participant HTN self-care activities using the H-SCALE (Hypertension Self-Care Activity Level Effects) | The 31-item instrument assess 6 HTN behavioral self-care activities recommended for optimal HTN management | 6 months post-intervention |
Change from baseline PRAPARE score. The PRAPARE assessment tool will be used to calculate a tally risk score indicating the cumulative number of SDOH risks a patient faces (including 15 SDOH domains). |
| Immediate post-intervention |
| Preliminary Efficacy of Intervention - BP Self-Management: Self-efficacy for HTN management | Change from baseline score. Self-efficacy to change health behaviors to manage HTN as measured by a 5-item instrument. | Immediate post-intervention |
| Self Efficacy for Medication Adherence as measured by the MASES scale (medication adherence self-efficacy scale) | Change from baseline score. The 13-item instrument assesses patients' confidence in their ability to take their BP medications in a variety of situations. | Immediate post-intervention |
Participant engagement with sharing board measured by number of posts per month by each participant |
| 3 months post-intervention |
| Intervention Feasibility Measures - Participant Engagement with Sharing Board | Participant engagement with sharing board measured by number of posts per month by each participant | 6 months post-intervention |
| Intervention Feasibility Measures - Participant Engagement with Modules | Participant engagement with education modules measured by number of modules completed out of 10 | Immediate post-intervention |
| Intervention Satisfaction Measures - Participant Satisfaction with FAITH! HTN App | Participant satisfaction with FAITH! HTN App measured by the Health Information Technology Usability Evaluation Scale (Health-ITUES). 20 items are assessed, each on a 5-point scale ranging from 1 (strongly disagree) to 5 (strongly agree). A higher total sum indicates higher perceived usability of the technology. | Immediate post-intervention |
| Rochester |
| Minnesota |
| 55905 |
| United States |
| Open Cities Health Center | Saint Paul | Minnesota | 55104 | United States |