Assessing and Promoting Resilience in Patients With Adult Congenital Heart Disease

Study Overview
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Brief Summary
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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
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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.

Official Title
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Assessing and Promoting Resilience in Patients With Adult Congenital Heart Disease

Conditions
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Congenital Heart Disease

Intervention / Treatment
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* Behavioral: Promoting Resilience in Stress Management (PRISM)
* Other: Usual Care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PRISM Intervention<br>Subjects in this group will receive the PRISM intervention | Behavioral: Promoting Resilience in Stress Management (PRISM)<br>* Develops personal resilience resources through 1:1 sessions with a PRISM coach.<br>|
| Placebo Comparator: Usual Care<br>Subjects in this arm will receive usual care | Other: Usual Care<br>* No additional study-specific interaction with subjects. Subjects continue to receive usual medical care.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of patients who enroll in the study among those eligible during the recruitment period | Feasibility | 3 months | 
| The proportion of patients who complete the PRISM intervention among those randomized to intervention. | Feasibility | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resilience | 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. | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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resilience, adult congenital heart disease, stress management, advance care planning