Assessing and Promoting Resilience in Patients With Adult Congenital Heart Disease
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Congenital Heart Disease
- Sponsor
- University of Washington
- Enrollment
- 78
- Locations
- 1
- Primary Endpoint
- Feasibility of Enrollment
- Status
- Completed
- Last Updated
- 4 months ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Jill Steiner
Assistant Professor, School of Medicine
University of Washington
Eligibility Criteria
Inclusion Criteria
- •adults with moderate or complex ACHD, stages B, C, or D as defined by the 2018 ACHD guidelines
- •receive care in our health system
Exclusion Criteria
- •diagnosis of another life-limiting illness
- •inability to participate in study activities independently and in English
Outcomes
Primary Outcomes
Feasibility of Enrollment
Time Frame: 3 months
The proportion of patients who enroll in the study among those eligible during the recruitment period
Feasibility of PRISM
Time Frame: 3 months
The proportion of patients who complete the PRISM intervention among those randomized to intervention.
Secondary Outcomes
- Mean Resilience(3 months)