Assessing and Promoting Resilience in Patients With Adult Congenital Heart Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 78
- 试验地点
- 2
- 主要终点
- Feasibility of Enrollment
研究概览
简要总结
The purpose of this study is to evaluate the feasibility and preliminary efficacy of the Promoting Resilience in Stress Management (PRISM) intervention in patients with adult congenital heart disease.
详细描述
After consent is obtained, eligible patients (moderate or complex ACHD, stages B, C, or D) will complete the baseline study measures assessment and be randomized to receive PRISM or usual care (anticipated n=86, 43 per group). Patients in the intervention group will participate in the six PRISM sessions over 3 months. At 3 months following enrollment, patients in both groups will again complete study measures. We will define feasibility as a) the proportion of eligible patients who enroll and b) the proportion of patients who complete the intervention among those randomized to intervention. We will define preliminary efficacy as the change in mean resilience from baseline to 3 months after randomization between those randomized to intervention and usual care. Exploratory analyses will examine PRISM's impact on patient-centered outcomes of quality of life, symptoms of anxiety and depression, and perceived competence for health 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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •adults with moderate or complex ACHD, stages B, C, or D as defined by the 2018 ACHD guidelines
- •receive care in our health system
排除标准
- •diagnosis of another life-limiting illness
- •inability to participate in study activities independently and in English
结局指标
主要结局
Feasibility of Enrollment
时间窗: 3 months
The proportion of patients who enroll in the study among those eligible during the recruitment period
Feasibility of PRISM
时间窗: 3 months
The proportion of patients who complete the PRISM intervention among those randomized to intervention.
次要结局
- Mean Resilience(3 months)
研究者
Jill Steiner
Assistant Professor, School of Medicine
University of Washington
