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Completed

NCT Number: NCT04554147

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.

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Key information

Conditions

High Blood Pressure Cardiovascular Diseases Hypertension Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

North Point Health & Wellness Center, Minneapolis, Minnesota, United States

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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.

Primary outcomes

  1. Blood pressure (systolic and diastolic, mmHg)

    Time frame: 0 months post intervention

    Change from baseline blood pressure.

  2. Blood pressure (systolic and diastolic, mmHg)

    Time frame: 3 months post intervention

    Change from baseline blood pressure.

  3. Blood pressure (systolic and diastolic, mmHg)

    Time frame: 6 months post intervention

    Change from baseline blood pressure.

  4. Intervention Feasibility Measures - Participant Engagement with Self-Monitoring

    Time frame: Immediate post-intervention

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

  5. Intervention Feasibility Measures - Participant Engagement with Self-Monitoring

    Time frame: Time Frame: 3 months post-intervention

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

  6. 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

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

    Time frame: Immediate post-intervention

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

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

    Time frame: 3 months post-intervention

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

  9. 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

Secondary outcomes

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

    Time frame: Immediate post intervention

    Change in percentage correct scores (pre- and post- self-assessments) for each education module by patient and as a conglomerate (mean) for all patients.

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

    Time frame: Immediate post-intervention

    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).

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

    Time frame: Immediate post-intervention

    Change from baseline score. Self-efficacy to change health behaviors to manage HTN as measured by a 5-item instrument.

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

    Time frame: Immediate post-intervention

    Change from baseline score. The 13-item instrument assesses patients' confidence in their ability to take their BP medications in a variety of situations.

Other outcomes

  1. Intervention Feasibility Measures - Participant Engagement with Sharing Board

    Time frame: Immediate post-intervention

    Participant engagement with sharing board measured by number of posts per week by each participant

  2. Intervention Feasibility Measures - Participant Engagement with Sharing Board

    Time frame: 3 months post-intervention

    Participant engagement with sharing board measured by number of posts per month by each participant

  3. Intervention Feasibility Measures - Participant Engagement with Sharing Board

    Time frame: 6 months post-intervention

    Participant engagement with sharing board measured by number of posts per month by each participant

  4. Intervention Feasibility Measures - Participant Engagement with Modules

    Time frame: Immediate post-intervention

    Participant engagement with education modules measured by number of modules completed out of 10

  5. Intervention Satisfaction Measures - Participant Satisfaction with FAITH! HTN App

    Time frame: Immediate post-intervention

    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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2023
First posted
Sep 18, 2020
Registry last updated
Apr 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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