Assessing and Promoting Resilience in Patients With Adult Congenital Heart Disease (PRISMACHD)

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.

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.

No additional study-specific interaction with subjects. Subjects continue to receive usual medical care.

The proportion of patients who enroll in the study among those eligible during the recruitment period

The proportion of patients who complete the PRISM intervention among those randomized to intervention.

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.

Functional Assessment of Chronic Illness Therapy - Palliative Care 14-item version (FACIT-PAL 14): 14-item measurement of chronic-illness-related quality of life, created based on the original 46-item tool. Questions revolve around symptom burden and emotional support. Each item consists of a 5-point scale, scored from 0-4, with an overall range of 0-56 points. Higher scores indicate better quality of life.

Hospital Anxiety and Depression Scale (HADS: 14-item tool to assess symptoms related to anxiety and depression. It is not intended to diagnose these conditions, but rather to assess the burden of symptoms. Each item is scored on a 4-point scale, scored from 0-3, with scores for each subscale ranging from 0-21. Higher scores indicate higher symptom severity.); Kessler-6 Psychological Distress Scale (K-6: 6-item inventory measuring the level of global psychological distress. Symptoms are rated on a 5-point scale, scored from 0-4, with an overall range of 0 to 24 points. Higher scores reflect greater distress, with scores >6 suggesting "high" distress and scores >12 suggesting "serious" distress.)

Perceived Competence Scale (PCS: 4-item tool that asks about competence in managing one's disease process. Each item consists of a 7-point scale, ranging from "Not at all true" to "Very true." The tool is scored by calculating the mean response across all questions. Higher scores indicate higher perceived competence. )

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