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临床试验/NCT04738474
NCT04738474已完成不适用

Assessing and Promoting Resilience in Patients With Adult Congenital Heart Disease

University of Washington2 个研究点 分布在 1 个国家目标入组 78 人开始时间: 2023年3月15日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jill Steiner

Assistant Professor, School of Medicine

University of Washington

研究点 (2)

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