Assessing and Promoting Resilience in Patients With Adult Congenital Heart Disease

Not Applicable

Completed

• Conditions: Congenital Heart Disease
• Interventions: Other: Usual Care; Behavioral: Promoting Resilience in Stress Management (PRISM)

• Registration Number: NCT04738474
• Lead Sponsor: University of Washington

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.

Study Timeline

• Study First Submitted: 2021-02-01
• Study First Submitted QC: 2021-02-03
• Study First Posted: 2021-02-04
• Study Start: 2023-03-15
• Primary Completion: 2024-07-25
• Study Completion: 2024-07-25
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-01
• Last Update Posted: 2024-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 78

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

Read More

Exclusion Criteria

• diagnosis of another life-limiting illness
• inability to participate in study activities independently and in English

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual Care	Usual Care	Subjects in this arm will receive usual care
PRISM Intervention	Promoting Resilience in Stress Management (PRISM)	Subjects in this group will receive the PRISM intervention

Primary Outcome Measures

Name	Time	Method
The proportion of patients who enroll in the study among those eligible during the recruitment period	3 months	Feasibility
The proportion of patients who complete the PRISM intervention among those randomized to intervention.	3 months	Feasibility

Secondary Outcome Measures

Name	Time	Method
Resilience	3 months	change in mean resilience (as defined by mean CDRISC-10 score) from baseline to 3 months after randomization between those randomized to intervention and usual care. CDRISC-10: 10-item measurement of inherent resiliency, created based on the original 25-item tool. Questions revolve around personal problem-solving and approaches to adversity. Each item consists of a 5-point scale, scored from 0-4, with an overall range of 0-40 points. Higher scores indicate higher perceived resilience.

Trial Locations

Locations (1)

University of Washington; 🇺🇸 Seattle, Washington, United States