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

University of Washington

Status: Completed

Conditions: Congenital Heart Disease

Treatments: Behavioral: Promoting Resilience in Stress Management (PRISM); Other: Usual Care

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04738474

STUDY00008661

K23HL151801-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 78 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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78 participants in 2 patient groups, including a placebo group

PRISM Intervention

Experimental group

Description:

Subjects in this group will receive the PRISM intervention

Treatment:

Behavioral: Promoting Resilience in Stress Management (PRISM)

Usual Care

Placebo Comparator group

Description:

Subjects in this arm will receive usual care

Treatment:

Other: Usual Care