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Completed

NCT Number: NCT04738474

Assessing and Promoting Resilience in Patients With Adult Congenital Heart Disease

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.

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Key information

Conditions

Congenital Heart Disease Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Washington

Seattle, Washington, 98195, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Promoting Resilience In Stress Management (PRISM)

Behavioral

Develops personal "resilience resources" through 1:1 sessions with a PRISM coach.

Usual Care

Other

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

Primary outcomes

  1. Feasibility of Enrollment

    Time frame: 3 months

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

  2. Feasibility of PRISM

    Time frame: 3 months

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

Secondary outcomes

  1. Mean Resilience

    Time frame: 3 months

    Mean (SD) resilience scores (as defined by mean CDRISC-10 score) were compared between treatment and control groups at the end of the 3-month study period. Significance of treatment effect was evaluated using the change in mean resilience (difference between scores at 3 months vs baseline). 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.

Other outcomes

  1. Health-Related Quality of Life

    Time frame: 3 months

    EuroQOL 5D-3L: 6-item measurement of health-related quality of life. The first 5 questions ask about symptoms and any health-related limitations. Each of these 5 items is scored on a 3-point scale, yielding a 5-digit number which can be indexed according to country (for the United States, values are -0.11 to 1). Higher scores indicate better quality of life.

  2. Health-Related Quality of Life - VAS

    Time frame: 3 months

    EuroQOL 5D-3L Visual Analog Scale (VAS). The final question in EuroQOL asks about health status on a visual analog scale, 0-100, where 100 is perfect health.

  3. Quality of Life - LAS

    Time frame: 3 months

    Single-item assessment of quality of life, continuous 0-100 scale where 100 indicates perfect quality of life.

  4. Psychological Distress

    Time frame: 3 months

    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.)

  5. Competence in Managing Healthcare

    Time frame: 3 months

    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 1 "Not at all true" to 7 "Very true." The tool is scored by calculating the mean response across all 4 questions (range 1-7). Higher scores indicate higher perceived competence.

  6. Comfort With Advance Care Planning, With Family

    Time frame: 3 months

  7. Comfort With Advance Care Planning, With Doctor

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Acronym: PRISMACHD

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Feb 4, 2021
Registry last updated
Dec 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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