HTN App for HTN Control and Cardiovascular Health Among African-Americans

Hypertension Clinical Trial

Official title:

FAITH! Hypertension App to Improve Hypertension Control and Cardiovascular Health Among African-Americans: A Decentralized Randomized Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06346886
• Other study ID #: 23-011703
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2024
• Est. completion date: July 2025

Study information

• Verified date: May 2024
• Source: Mayo Clinic
• Contact: Lainey Moen
• Phone: 507-266-7062
• Email: Moen.Lainey[@]mayo.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to test the hypertension (HTN) app-based intervention to see if it is more effective in improving uncontrolled HTN and HTN self-care among Africian-Americans from baseline to post-intervention (immediate, 3 months and 6 months post-intervention) as compared to the standard of care.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: July 2025
• Est. primary completion date: July 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• African-American (AA) adults that are established patients at Neighborhood HealthSource in Minneapolis, Minnesota.

• Receives primary care (i.e., has designated primary care provider) at the partnering FQHCs and intent to continue care there for next 12 months

• African American race/ethnicity

• Men and women aged =18 years

• Uncontrolled HTN (defined as Stage 2 HTN with a BP =140/90 mmHg [as per 2017 American College of Cardiology/American Heart Association HTN Guidelines32] at most recent outpatient evaluation, with or without BP medications)

• Documented diagnosis of HTN in EHR

• At least 1 office visit at the partnering FQHCs in the prior year

• Smartphone ownership (supporting iOS or Android Systems)

• Active email address and willingness to utilize it throughout the study

• Basic Internet navigation skills (for example, can search for information on websites, open and send emails)

• Access to the Internet on at least a weekly basis (such as at home, a family member's or friend's home, church, library/community center, school/university, Internet café, etc.)?

Exclusion Criteria:

• 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).

• No primary care provider at partnering FQHC

Related Conditions & MeSH terms

• Hypertension

Intervention

Behavioral:
• FAITH! HTN app
Participants will remain in the intervention for 11 weeks. The app-based intervention is a tailored program to promote HTN self-management and knowledge through an 11-module educational video series with a focus on HTN. Participants will also be provided with at home Blood Pressure (BP) monitoring system to allow for self-tracking of BP measurements(automatically synchronized with the app). The app will include pre-post module quizzes, a tracking component for participants to input self-monitored measures (medication adherence, diet, physical activity, etc.). The app sharing board will be a moderated discussion platform and feed for participant interaction by posting healthy lifestyle practices through text, photographs and video to foster discussion on HTN management barriers/facilitators. The project team will post weekly to the sharing board on HTN-related topics to generate discussion among patients.

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	Miami Heart Research Institute Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Absolute Change in Systolic Blood Pressure (BP)	Systolic BP (mmHg) will be measured as an average of 3 sitting readings with an oscillometric automated device during in-clinic health assessments.	Baseline, immediate post intervention
Primary	HTN Self-Care as reported by H-SCALE(HTN Self-Care Activity Level Effects)	The H-SCALE is a 31-item instrument that assesses 6 HTN behavioral self-care activities recommended for optimal HTN management (BP medication adherence, weight loss/ideal body weight maintenance, adoption of a low-salt diet, regular physical activity for =30 minutes/day, limiting alcohol intake, and ceasing tobacco use).	Baseline, immediate, 3 months, 6 months post intervention
Secondary	Proportion of subjects reaching BP control	Proportion of subjects reaching BP control (defined as meeting target BP of <140/90 mmHg)	Immediate, 3 months, 6 months post intervention
Secondary	Change in BP as assessed by home BP cuff measurements	BP (mmHg) will be measured 3 times per week during the 11-week intervention period using a home BP monitoring system. The 3 weekly measurements will be averaged and average weekly BP will be compared from baseline to immediate post intervention to determine the change in BP. This outcome is only evaluated in the intervention group as the control group will not undergo home BP cuff measurements.	Baseline, immediate post intervention
Secondary	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	Hypertension (HTN) Knowledge as assessed by 11-item questionnaire	HTN Knowledge will be assessed using a previously validated 11-item questionnaire which asks participants questions about the definition, prevention, management and complications of hypertension. Responses are record as true, false or uncertain to each question with true response receiving a score of 1 and false or uncertain responses receiving a score of 0. Total scores on the questionnaire range from 0-11 with higher scores reflecting better HTN knowledge.	Baseline, immediate post intervention

External Links

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