Patient-Provider-Community Health Worker Integrated Care Model: Use of an Innovative Mobile Health Intervention to Improve Hypertension Among African-Americans
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 16
- 试验地点
- 3
- 主要终点
- HTN Self-Care Measures - Participant HTN self-care activities using the H-SCALE (Hypertension Self-Care Activity Level Effects)
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 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 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)
排除标准
- •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).
研究组 & 干预措施
FAITH! App-enhanced Hypertension Intervention
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.
干预措施: FAITH! App-enhanced Hypertension Intervention (Behavioral)
结局指标
主要结局
HTN Self-Care Measures - Participant HTN self-care activities using the H-SCALE (Hypertension Self-Care Activity Level Effects)
时间窗: 6 months post-intervention
The 31-item instrument assess 6 HTN behavioral self-care activities recommended for optimal HTN management
Blood pressure (systolic and diastolic, mmHg)
时间窗: 6 months post intervention
Change from baseline blood pressure.
Intervention Feasibility Measures - Participant Engagement with Self-Monitoring
时间窗: 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
Blood pressure (systolic and diastolic, mmHg)
时间窗: 0 months post intervention
Change from baseline blood pressure.
Blood pressure (systolic and diastolic, mmHg)
时间窗: 3 months post intervention
Change from baseline blood pressure.
Intervention Feasibility Measures - Participant Engagement with Self-Monitoring
时间窗: Immediate post-intervention
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
时间窗: 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
HTN Self-Care Measures - Participant HTN self-care activities using the H-SCALE (Hypertension Self-Care Activity Level Effects)
时间窗: Immediate post-intervention
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)
时间窗: 3 months post-intervention
The 31-item instrument assess 6 HTN behavioral self-care activities recommended for optimal HTN management
次要结局
- Preliminary Efficacy of Intervention - CV Health Knowledge as measured by module assessment scores(Immediate post intervention)
- Self Efficacy for Medication Adherence as measured by the MASES scale (medication adherence self-efficacy scale)(Immediate post-intervention)
- Preliminary Efficacy of Intervention - BP Self-Management: Self-efficacy for HTN management(Immediate post-intervention)
- Social Determinants of Health (SDOH, PRAPARE (Protocol for Responding to and Addressing Patient Assets, Risks, and Experiences) tool)(Immediate post-intervention)
研究者
LaPrincess C. Brewer
Principal Investigator
Mayo Clinic