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PRISM for Congenital Heart Disease (PRISMACHD Trial)

N/A

Recruiting

Led By Jill M Steiner, MD,MS

Research Sponsored by University of Washington

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adults with moderate or complex ACHD, stages B, C, or D as defined by the 2018 ACHD guidelines

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months

Awards & highlights

PRISMACHD Trial Summary

This trial tests a resilience-promoting program to help people with heart defects manage stress.

Who is the study for?

This trial is for adults with moderate to complex adult congenital heart disease (ACHD), specifically stages B, C, or D as per the 2018 ACHD guidelines. Participants must be receiving care within the health system conducting the study and able to engage in activities independently in English. Those with another life-limiting illness or unable to participate on their own are excluded.Check my eligibility

What is being tested?

The study is testing a program called Promoting Resilience in Stress Management (PRISM) against usual care practices for patients with ACHD. The goal is to see if PRISM can help improve resilience and manage stress better than standard treatments.See study design

What are the potential side effects?

Since PRISM is a non-medical intervention focused on stress management, it may not have typical medical side effects. However, participants might experience emotional discomfort when discussing personal issues related to their condition.

PRISMACHD Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have adult congenital heart disease at a moderate or complex stage.

PRISMACHD Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

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

Secondary outcome measures

Resilience

Other outcome measures

Competence in Managing Healthcare

Health-Related Quality of Life

Psychological Distress

PRISMACHD Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: PRISM InterventionExperimental Treatment1 Intervention

Subjects in this group will receive the PRISM intervention

Group II: Usual CarePlacebo Group1 Intervention

Subjects in this arm will receive usual care

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of WashingtonLead Sponsor

1,741 Previous Clinical Trials

1,847,680 Total Patients Enrolled

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

3,840 Previous Clinical Trials

47,852,038 Total Patients Enrolled

Jill M Steiner, MD,MSPrincipal InvestigatorUniversity of Washington

Media Library

Promoting Resilience in Stress Management (PRISM) Clinical Trial Eligibility Overview. Trial Name: NCT04738474 — N/A

Congenital Heart Disease Research Study Groups: PRISM Intervention, Usual Care

Congenital Heart Disease Clinical Trial 2023: Promoting Resilience in Stress Management (PRISM) Highlights & Side Effects. Trial Name: NCT04738474 — N/A

Promoting Resilience in Stress Management (PRISM) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04738474 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the sample size of this research endeavor?

"Affirmative. According to clinicaltrials.gov, this health research project began recruitment on February 15th 2023 and the latest update was made May 9th 2023. As such, 86 participants are needed from one medical setting for participation in the trial."

Answered by AI

Are there still opportunities to join this clinical experiment?

"Affirmative, the information available on clinicaltrials.gov indicates that this research endeavour is currently seeking participants; it was first posted on February 15th 2023 and latest edited on May 9th of the same year. A total of 86 patients need to be recruited from a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Assessing and Promoting Resilience in Patients With Adult Congenital Heart Disease

Jill Steiner 2023. "Assessing and Promoting Resilience in Patients With Adult Congenital Heart Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04738474.

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