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

Официальное название

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

Обзор

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.

Вмешательства

• Поведенческое 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-monitore

Первичные конечные точки

• Absolute Change in Systolic Blood Pressure (BP) [Срок оценки: Baseline, immediate post intervention]
• HTN Self-Care as reported by H-SCALE(HTN Self-Care Activity Level Effects) [Срок оценки: Baseline, immediate, 3 months, 6 months post intervention]

Вторичные конечные точки (4)

• Proportion of subjects reaching BP control [Срок оценки: Immediate, 3 months, 6 months post intervention]
• Change in BP as assessed by home BP cuff measurements [Срок оценки: Baseline, immediate post intervention]
• CV Health Knowledge as measured by module assessment scores [Срок оценки: Immediate post intervention]
• Hypertension (HTN) Knowledge as assessed by 11-item questionnaire [Срок оценки: Baseline, immediate post intervention]

Критерии участия

Критерии включения

• 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.)?

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Mayo Clinic — Rochester

Идентификаторы

NCT: NCT06346886 · 23-011703

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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