Use of an Innovative Mobile Health Intervention to Improve Hypertension Among African-Americans

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

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.

Study Overview

• Status: Completed
• Conditions: High Blood Pressure
• Intervention / Treatment: Behavioral: FAITH! App-enhanced Hypertension Intervention

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).

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55411
      • North Point Health & Wellness Center
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
    • Saint Paul, Minnesota, United States, 55104
      • Open Cities Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: FAITH! App-enhanced Hypertension Intervention; 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.

Behavioral: FAITH! App-enhanced Hypertension Intervention; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)	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

Secondary Outcome Measures

Outcome Measure	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)	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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 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	Participant engagement with sharing board measured by number of posts per month by each participant	3 months 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

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: LaPrincess C Brewer, MD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2021
• Primary Completion (Actual): August 25, 2021
• Study Completion (Actual): June 30, 2023

Study Registration Dates

• First Submitted: July 12, 2020
• First Submitted That Met QC Criteria: September 12, 2020
• First Posted (Actual): September 18, 2020

Study Record Updates

• Last Update Posted (Actual): April 19, 2024
• Last Update Submitted That Met QC Criteria: April 18, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: mobile health; health disparities; community health; African-Americans
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: 19-009247

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No