NCT04738474

Assessing and Promoting Resilience in Patients With Adult Congenital Heart Disease

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 78 (actual)
• Sponsor: University of Washington · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Congenital Heart Disease

Interventions

Type	Name	Description
BEHAVIORAL	Promoting Resilience in Stress Management (PRISM)	Develops personal "resilience resources" through 1:1 sessions with a PRISM coach.
OTHER	Usual Care	No additional study-specific interaction with subjects. Subjects continue to receive usual medical care.

Timeline

• Start date: 2023-03-15
• Primary completion: 2024-07-25
• Completion: 2024-07-25
• First posted: 2021-02-04
• Last updated: 2025-12-15
• Results posted: 2025-10-30

Locations

1 site across 1 country: United States