Walk Together: A Family-Based Intervention for Hypertension In African Americans
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 2
- 主要终点
- Feasibility of intervention as measured by the rate of refusal among eligible patients/family members
研究概览
简要总结
The goal of this study is to determine the feasibility and acceptability of a novel family-based hypertension self-management intervention, Walk Together, adapted from an existing empirically-supported dyadic intervention, for implementation in primary care.
详细描述
Hypertension is the driving risk factor for disparities in mortality and life expectancy between African Americans and Whites. Hypertension self-management (including blood pressure monitoring, diet, exercise, and other lifestyle changes) is critical for improving hypertension control, and prior interventions have emphasized promoting patient-level behavior change to improve self-management adherence. Though family members make substantial contributions to hypertension self-management for African Americans, family support is consistently underutilized by current hypertension self-management interventions. Family-based interventions for improving self-management are effective for other chronic conditions, including for African Americans. Evidence has demonstrated the unique and important role of family support in African Americans' hypertension management, and African Americans' preferences for the direct involvement of family in hypertension interventions. The study team will develop a family-based hypertension self-management intervention ("Walk Together") for African Americans with uncontrolled hypertension that integrates community-based participatory perspectives in the specifics of the intervention. The study team will pilot trial the culturally-adapted intervention in a primary care setting in order to examine the feasibility and acceptability of the Walk Together protocol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Black or African American
- •Age 18 to 75
- •Two blood pressure values ≥ 130/ ≥ 80 in 12 months prior
- •Available family support person to join the intervention who agrees to participate
- •English-speaking
排除标准
- •Family support person is under the age of 18
- •Documented cognitive impairment in patient's medical record
- •Presence of severe psychiatric condition (i.e., current psychotic disorder or suicidality)
- •Participation in prior hypertension health education intervention
- •Prior participation in formative study activities (i.e., study focus groups)
结局指标
主要结局
Feasibility of intervention as measured by the rate of refusal among eligible patients/family members
时间窗: 11 months
Feasibility of intervention is measured by the rate of refusal among eligible patients/family members which is the number of participants refusing to consent
Adherence to the intervention as measured by the proportion of dyads successfully completing the four intervention components
时间窗: 11 months
Adherence to the intervention as measured by the proportion of dyads successfully completing the four intervention components
Adherence to the intervention as measured by the proportion of participants completing post-treatment assessments
时间窗: 11 months
Adherence to the intervention as measured by the proportion of participants completing post-treatment assessment
Attrition as measured by the proportion of consented participants who dropped out of the entire study
时间窗: 11 months
Attrition is defined as measured by the proportion of consented participants who dropped out of the entire study. If the dropout rate is more than 20% then it will be considered as attrition
Feasibility of intervention as measured by the number of participants accrued
时间窗: 11 months
Feasibility of intervention is measured by the number of participants accrued or consented and ready to participate to meet the recruitment goal of 30 dyads
Acceptability of intervention as measured by 8-item Client Satisfaction Questionnaire
时间窗: Protocol completion (approx. 24 months)
Acceptability of intervention is measured by 8-item Client Satisfaction Questionnaire. Possible scores range from 8 to 32, with higher values indicating higher satisfaction
次要结局
- Family relationship quality as measured by the FACES-IV Short Form at following session 3(Following session 3 (Feedback Session, approx. 2-3 weeks after Baseline))
- Health knowledge as measured by the Hypertension (HTN) Evaluation of Lifestyle and Management Knowledge scale at Baseline(Baseline)
- Family relationship quality as measured by the FACES-IV Short Form at following session 4(Following session 4 (Booster Check-in session, approx. 7-8 weeks after Baseline))
- Family relationship quality as measured by the Chronic Illness Resources Survey at Baseline(Baseline)
- Family relationship quality as measured by the Chronic Illness Resources Survey following session 3(Following session 3 (Feedback Session, approx. 2-3 weeks after Baseline))
- Health knowledge as measured by the Hypertension (HTN) Evaluation of Lifestyle and Management Knowledge scale following session 4(Following session 4 (Booster Check-in session, approx. 7-8 weeks after Baseline))
- HTN self-management as measured by the HTN Self-Care Activity Level Effects measure at Baseline(Following session 4 (Booster Check-in session, approx. 7-8 weeks after Baseline))
- Family relationship quality as measured by the FACES-IV Short Form at Baseline(Baseline)
- Health knowledge as measured by the Hypertension (HTN) Evaluation of Lifestyle and Management Knowledge scale following session 3(Following session 3 (Feedback Session, approx. 2-3 weeks after Baseline))
- Family relationship quality as measured by the Chronic Illness Resources Survey following session 4(Following session 4 (Booster Check-in session, approx. 7-8 weeks after Baseline))
研究者
Sarah Woods
ASSOC PROFESSOR - Family Medicine
University of Texas Southwestern Medical Center