Assessing and Promoting Resilience in Patients With Adult Congenital Heart Disease

NCT ID: NCT04738474

Last Updated: 2025-12-15

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-15

Study Completion Date

2024-07-25

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Congenital Heart Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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PRISM Intervention

Subjects in this group will receive the PRISM intervention

Group Type EXPERIMENTAL

Promoting Resilience in Stress Management (PRISM)

Intervention Type BEHAVIORAL

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

Usual Care

Subjects in this arm will receive usual care

Group Type PLACEBO_COMPARATOR

Usual Care

Intervention Type OTHER

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

Interventions

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Promoting Resilience in Stress Management (PRISM)

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

Intervention Type BEHAVIORAL

Usual Care

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

University of Washington

OTHER

Sponsor Role lead

Responsible Party

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Jill Steiner

Assistant Professor, School of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jill M Steiner, MD,MS

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

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University of Washington

Seattle, Washington, United States

Site Status

Countries

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United States

References

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Steiner JM, Marshall AR, Brumback L, Zhang YC, Glenn TM, Kovacs AH, Stout KK, Longenecker CT, Yi-Frazier JP, Rosenberg AR. A Randomized Trial of a Resilience-Building Intervention in Adult Outpatients With Congenital Heart Disease: Feasibility and Efficacy. JACC Adv. 2025 Oct;4(10 Pt 2):102164. doi: 10.1016/j.jacadv.2025.102164. Epub 2025 Sep 12.

Reference Type DERIVED
PMID: 40945428 (View on PubMed)

Steiner JM, Marshall AR, Kovacs AH, Engelberg RA, Brumback L, Stout KK, Longenecker CT, Yi-Frazier JP, Rosenberg AR. Rationale and design of a randomized controlled clinical trial of a resilience-building intervention in adults with congenital heart disease. Contemp Clin Trials. 2024 Oct;145:107638. doi: 10.1016/j.cct.2024.107638. Epub 2024 Jul 22.

Reference Type DERIVED
PMID: 39047811 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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K23HL151801-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00008661

Identifier Type: -

Identifier Source: org_study_id

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