FAITH! Hypertension App to Improve Hypertension Control and Cardiovascular Health Among African-Americans: A Decentralized Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Absolute Change in Systolic Blood Pressure (BP)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.)?
排除标准
- •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
研究组 & 干预措施
Intervention Group
African American adults with uncontrolled hypertension (HTN) will be assigned to complete an 11 week guided intervention using the FAITH! HTN app.
干预措施: FAITH! HTN app (Behavioral)
Control Group
African American adults with uncontrolled hypertension (HTN) will receive the standard of care of HTN management.
结局指标
主要结局
Absolute Change in Systolic Blood Pressure (BP)
时间窗: Baseline, immediate post intervention
Systolic BP (mmHg) will be measured as an average of 3 sitting readings with an oscillometric automated device during in-clinic health assessments.
HTN Self-Care as reported by H-SCALE(HTN Self-Care Activity Level Effects)
时间窗: Baseline, immediate, 3 months, 6 months post intervention
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).
次要结局
- Change in BP as assessed by home BP cuff measurements(Baseline, immediate post intervention)
- Proportion of subjects reaching BP control(Immediate, 3 months, 6 months post intervention)
- CV Health Knowledge as measured by module assessment scores(Immediate post intervention)
- Hypertension (HTN) Knowledge as assessed by 11-item questionnaire(Baseline, immediate post intervention)
研究者
LaPrincess C. Brewer
Principal Investigator
Mayo Clinic