Clinical trial NCT04554147: Use of an Innovative Mobile Health Intervention to Improve Hypertension Among African-Americans
Official title: Patient-Provider-Community Health Worker Integrated Care Model: Use of an Innovative Mobile Health Intervention to Improve Hypertension Among African-Americans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: High Blood Pressure
Keywords: health disparities
mobile health
community health
African-Americans
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2020-09-18
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: PREVENTION

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).

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).

Primary outcomes:
measure: Blood pressure (systolic and diastolic, mmHg)
timeFrame: 0 months post intervention
measure: Blood pressure (systolic and diastolic, mmHg)
timeFrame: 3 months post intervention
measure: Blood pressure (systolic and diastolic, mmHg)
timeFrame: 6 months post intervention
measure: Intervention Feasibility Measures - Participant Engagement with Self-Monitoring
timeFrame: Immediate post-intervention
measure: Intervention Feasibility Measures - Participant Engagement with Self-Monitoring
timeFrame: Time Frame: 3 months post-intervention
measure: Intervention Feasibility Measures - Participant Engagement with Self-Monitoring
timeFrame: Time Frame: 6 months post-intervention
measure: HTN Self-Care Measures - Participant HTN self-care activities using the H-SCALE (Hypertension Self-Care Activity Level Effects)
timeFrame: Immediate post-intervention
measure: HTN Self-Care Measures - Participant HTN self-care activities using the H-SCALE (Hypertension Self-Care Activity Level Effects)
timeFrame: 3 months post-intervention
measure: HTN Self-Care Measures - Participant HTN self-care activities using the H-SCALE (Hypertension Self-Care Activity Level Effects)
timeFrame: 6 months post-intervention
Secondary outcomes:
measure: Preliminary Efficacy of Intervention - CV Health Knowledge as measured by module assessment scores
timeFrame: Immediate post intervention
measure: Social Determinants of Health (SDOH, PRAPARE (Protocol for Responding to and Addressing Patient Assets, Risks, and Experiences) tool)
timeFrame: Immediate post-intervention
measure: Preliminary Efficacy of Intervention - BP Self-Management: Self-efficacy for HTN management
timeFrame: Immediate post-intervention
measure: Self Efficacy for Medication Adherence as measured by the MASES scale (medication adherence self-efficacy scale)
timeFrame: Immediate post-intervention
Other outcomes:
measure: Intervention Feasibility Measures - Participant Engagement with Sharing Board
timeFrame: Immediate post-intervention
measure: Intervention Feasibility Measures - Participant Engagement with Sharing Board
timeFrame: 3 months post-intervention
measure: Intervention Feasibility Measures - Participant Engagement with Sharing Board
timeFrame: 6 months post-intervention
measure: Intervention Feasibility Measures - Participant Engagement with Modules
timeFrame: Immediate post-intervention
measure: Intervention Satisfaction Measures - Participant Satisfaction with FAITH! HTN App
timeFrame: Immediate post-intervention
Locations:
city: Minneapolis
country: United States
facility: North Point Health & Wellness Center
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Saint Paul
country: United States
facility: Open Cities Health Center
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: LaPrincess C Brewer, MD
role: PRINCIPAL_INVESTIGATOR
References: