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

NCT04554147 | Completed

• 1 other identifier: 19-009247
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 3

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.

Conditions

High Blood Pressure

Keywords

health disparities; mobile health; community health; African-Americans

Outcome Measures

Primary Outcomes (9)

• 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 Outcomes (4)

• Preliminary Efficacy of Intervention - CV Health Knowledge as measured by module assessment scores

  Immediate post intervention

• Social Determinants of Health (SDOH, PRAPARE (Protocol for Responding to and Addressing Patient Assets, Risks, and Experiences) tool)

  Immediate post-intervention

• Preliminary Efficacy of Intervention - BP Self-Management: Self-efficacy for HTN management

  Immediate post-intervention

• Self Efficacy for Medication Adherence as measured by the MASES scale (medication adherence self-efficacy scale)

  Immediate post-intervention

Other Outcomes (5)

• Intervention Feasibility Measures - Participant Engagement with Sharing Board

  Immediate post-intervention

• Intervention Feasibility Measures - Participant Engagement with Sharing Board

  3 months post-intervention

• Intervention Feasibility Measures - Participant Engagement with Sharing Board

  6 months post-intervention

Study Arms (1)

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.

Behavioral: FAITH! App-enhanced Hypertension Intervention

Interventions

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.

FAITH! App-enhanced Hypertension Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• African American race/ethnicity
• 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)

You may not qualify if:

• 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).

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (3)

North Point Health & Wellness Center

Minneapolis, Minnesota, 55411, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Open Cities Health Center

Saint Paul, Minnesota, 55104, United States

Location

Related Publications (1)

• 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.

  PMID: 37115658 DERIVED

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• LaPrincess C Brewer, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: July 12, 2020
• First Posted: September 18, 2020
• Study Start: April 15, 2021
• Primary Completion: August 25, 2021
• Study Completion: June 30, 2023
• Last Updated: April 19, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)