Assessing and Promoting Resilience in Patients With Adult Congenital Heart Disease

Congenital Heart Disease Clinical Trial

— PRISMACHD  

Official title:

Assessing and Promoting Resilience in Patients With Adult Congenital Heart Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04738474
• Other study ID #: STUDY00008661
• Secondary ID: K23HL151801-01A1
• Status: Recruiting
• Phase: N/A
• Start date: March 15, 2023
• Est. completion date: December 2024

Study information

• Verified date: January 2024
• Source: University of Washington
• Contact: Jill M Steiner, MD, MS
• Phone: 206-997-7369
• Email: jills8[@]uw.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 86
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Congenital Heart Disease
• Heart Defects, Congenital
• Heart Diseases

Intervention

Behavioral:
• Promoting Resilience in Stress Management (PRISM)
Develops personal "resilience resources" through 1:1 sessions with a PRISM coach.

Other:
• Usual Care
No additional study-specific interaction with subjects. Subjects continue to receive usual medical care.

Locations

Country	Name	City	State
United States	University of Washington	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Health-Related Quality of Life	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 item is scored on a 3-point scale. Scores are totaled and then indexed according to country. Higher scores indicate better quality of life. The final question asks about health status on a visual analog scale, 0-100, where 100 is perfect health.	3 months
Other	Psychological Distress	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.)	3 months
Other	Competence in Managing Healthcare	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. )	3 months
Primary	The proportion of patients who enroll in the study among those eligible during the recruitment period	Feasibility	3 months
Primary	The proportion of patients who complete the PRISM intervention among those randomized to intervention.	Feasibility	3 months
Secondary	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