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

High Blood Pressure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04554147
• Other study ID #: 19-009247
• Status: Completed
• Phase: N/A
• Start date: April 15, 2021
• Est. completion date: June 30, 2023

Study information

• Verified date: April 2024
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: June 30, 2023
• Est. primary completion date: August 25, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• High Blood Pressure
• Hypertension

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.

Locations

Country	Name	City	State
United States	North Point Health & Wellness Center	Minneapolis	Minnesota
United States	Mayo Clinic	Rochester	Minnesota
United States	Open Cities Health Center	Saint Paul	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	Intervention Feasibility Measures - Participant Engagement with Modules	Participant engagement with education modules measured by number of modules completed out of 10	Immediate post-intervention
Other	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
Primary	Blood pressure (systolic and diastolic, mmHg)	Change from baseline blood pressure.	0 months post intervention
Primary	Blood pressure (systolic and diastolic, mmHg)	Change from baseline blood pressure.	3 months post intervention
Primary	Blood pressure (systolic and diastolic, mmHg)	Change from baseline blood pressure.	6 months post intervention
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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