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Clinical Trials/NCT04554147
NCT04554147
Completed
N/A

Patient-Provider-Community Health Worker Integrated Care Model: Use of an Innovative Mobile Health Intervention to Improve Hypertension Among African-Americans

Mayo Clinic3 sites in 1 country16 target enrollmentApril 15, 2021

Overview

Phase
N/A
Intervention
Not specified
Conditions
High Blood Pressure
Sponsor
Mayo Clinic
Enrollment
16
Locations
3
Primary Endpoint
HTN Self-Care Measures - Participant HTN self-care activities using the H-SCALE (Hypertension Self-Care Activity Level Effects)
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

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.

Detailed Description

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).

Registry
clinicaltrials.gov
Start Date
April 15, 2021
End Date
June 30, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

LaPrincess C. Brewer

Principal Investigator

Mayo Clinic

Eligibility Criteria

Inclusion Criteria

  • African American race/ethnicity
  • 18 years or older
  • Receive primary care at one of the two partnering Federally Qualified Health Centers (FQHC) and intent to continue care there for next 6 months
  • Uncontrolled HTN (defined as BP ≥140/90 mmHg \[as per JNC7 Hypertension Guidelines68\] at most recent outpatient evaluation, with or without BP medications)
  • Documented diagnosis of HTN in EHR
  • At least 1 office visit at one of the two partnering FQHCs in prior year
  • Smartphone ownership (supporting iOS or Android Systems)

Exclusion Criteria

  • Unable to commit to participating in both focus groups (pre and post app refinement).
  • Diagnosis of a serious medical condition or disability that would make participation difficult (i.e. visual or hearing impairment, mental disability that would preclude independent use of the app).

Outcomes

Primary Outcomes

HTN Self-Care Measures - Participant HTN self-care activities using the H-SCALE (Hypertension Self-Care Activity Level Effects)

Time Frame: 6 months post-intervention

The 31-item instrument assess 6 HTN behavioral self-care activities recommended for optimal HTN management

Blood pressure (systolic and diastolic, mmHg)

Time Frame: 6 months post intervention

Change from baseline blood pressure.

Intervention Feasibility Measures - Participant Engagement with Self-Monitoring

Time Frame: Time Frame: 6 months post-intervention

Participant engagement with weekly blood pressure tracking measured by number of times participant engaged with the blood pressure feature

Secondary Outcomes

  • Preliminary Efficacy of Intervention - CV Health Knowledge as measured by module assessment scores(Immediate post intervention)
  • Self Efficacy for Medication Adherence as measured by the MASES scale (medication adherence self-efficacy scale)(Immediate post-intervention)
  • Preliminary Efficacy of Intervention - BP Self-Management: Self-efficacy for HTN management(Immediate post-intervention)
  • Social Determinants of Health (SDOH, PRAPARE (Protocol for Responding to and Addressing Patient Assets, Risks, and Experiences) tool)(Immediate post-intervention)

Study Sites (3)

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