search
Back to results

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

Primary Purpose

High Blood Pressure

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
FAITH! App-enhanced Hypertension Intervention
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for High Blood Pressure focused on measuring health disparities, mobile health, community health, African-Americans

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • North Point Health & Wellness Center
  • Mayo Clinic
  • Open Cities Health Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

FAITH! App-enhanced Hypertension Intervention

Arm Description

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.

Outcomes

Primary Outcome Measures

Blood pressure (systolic and diastolic, mmHg)
Change from baseline blood pressure.
Blood pressure (systolic and diastolic, mmHg)
Change from baseline blood pressure.
Blood pressure (systolic and diastolic, mmHg)
Change from baseline blood pressure.
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
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
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
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
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
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

Secondary Outcome Measures

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.
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).
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.
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.

Full Information

First Posted
July 12, 2020
Last Updated
March 27, 2023
Sponsor
Mayo Clinic
search

1. Study Identification

Unique Protocol Identification Number
NCT04554147
Brief Title
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

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 15, 2021 (Actual)
Primary Completion Date
November 1, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
High Blood Pressure
Keywords
health disparities, mobile health, community health, African-Americans

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
FAITH! App-enhanced Hypertension Intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
FAITH! App-enhanced Hypertension Intervention
Intervention Description
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 Outcome Measure Information:
Title
Blood pressure (systolic and diastolic, mmHg)
Description
Change from baseline blood pressure.
Time Frame
0 months post intervention
Title
Blood pressure (systolic and diastolic, mmHg)
Description
Change from baseline blood pressure.
Time Frame
3 months post intervention
Title
Blood pressure (systolic and diastolic, mmHg)
Description
Change from baseline blood pressure.
Time Frame
6 months post intervention
Title
Intervention Feasibility Measures - Participant Engagement with Self-Monitoring
Description
Participant engagement with weekly blood pressure tracking measured by number of times participant engaged with the blood pressure feature
Time Frame
Immediate post-intervention
Title
Intervention Feasibility Measures - Participant Engagement with Self-Monitoring
Description
Participant engagement with weekly blood pressure tracking measured by number of times participant engaged with the blood pressure feature
Time Frame
Time Frame: 3 months post-intervention
Title
Intervention Feasibility Measures - Participant Engagement with Self-Monitoring
Description
Participant engagement with weekly blood pressure tracking measured by number of times participant engaged with the blood pressure feature
Time Frame
Time Frame: 6 months post-intervention
Title
HTN Self-Care Measures - Participant HTN self-care activities using the H-SCALE (Hypertension Self-Care Activity Level Effects)
Description
The 31-item instrument assess 6 HTN behavioral self-care activities recommended for optimal HTN management
Time Frame
Immediate post-intervention
Title
HTN Self-Care Measures - Participant HTN self-care activities using the H-SCALE (Hypertension Self-Care Activity Level Effects)
Description
The 31-item instrument assess 6 HTN behavioral self-care activities recommended for optimal HTN management
Time Frame
3 months post-intervention
Title
HTN Self-Care Measures - Participant HTN self-care activities using the H-SCALE (Hypertension Self-Care Activity Level Effects)
Description
The 31-item instrument assess 6 HTN behavioral self-care activities recommended for optimal HTN management
Time Frame
6 months post-intervention
Secondary Outcome Measure Information:
Title
Preliminary Efficacy of Intervention - CV Health Knowledge as measured by module assessment scores
Description
Change in percentage correct scores (pre- and post- self-assessments) for each education module by patient and as a conglomerate (mean) for all patients.
Time Frame
Immediate post intervention
Title
Social Determinants of Health (SDOH, PRAPARE (Protocol for Responding to and Addressing Patient Assets, Risks, and Experiences) tool)
Description
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).
Time Frame
Immediate post-intervention
Title
Preliminary Efficacy of Intervention - BP Self-Management: Self-efficacy for HTN management
Description
Change from baseline score. Self-efficacy to change health behaviors to manage HTN as measured by a 5-item instrument.
Time Frame
Immediate post-intervention
Title
Self Efficacy for Medication Adherence as measured by the MASES scale (medication adherence self-efficacy scale)
Description
Change from baseline score. The 13-item instrument assesses patients' confidence in their ability to take their BP medications in a variety of situations.
Time Frame
Immediate post-intervention
Other Pre-specified Outcome Measures:
Title
Intervention Feasibility Measures - Participant Engagement with Sharing Board
Description
Participant engagement with sharing board measured by number of posts per week by each participant
Time Frame
Immediate post-intervention
Title
Intervention Feasibility Measures - Participant Engagement with Sharing Board
Description
Participant engagement with sharing board measured by number of posts per month by each participant
Time Frame
3 months post-intervention
Title
Intervention Feasibility Measures - Participant Engagement with Sharing Board
Description
Participant engagement with sharing board measured by number of posts per month by each participant
Time Frame
6 months post-intervention
Title
Intervention Feasibility Measures - Participant Engagement with Modules
Description
Participant engagement with education modules measured by number of modules completed out of 10
Time Frame
Immediate post-intervention
Title
Intervention Satisfaction Measures - Participant Satisfaction with FAITH! HTN App
Description
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.
Time Frame
Immediate post-intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
LaPrincess C Brewer, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
North Point Health & Wellness Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55411
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Open Cities Health Center
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55104
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

Learn more about this trial

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

We'll reach out to this number within 24 hrs