NCT04738474

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
78

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 1, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 4, 2021

Completed
2.1 years until next milestone

Study Start

First participant enrolled

March 15, 2023

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 25, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 25, 2024

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

October 30, 2025

Completed
Last Updated

December 15, 2025

Status Verified

November 1, 2025

Enrollment Period

1.4 years

First QC Date

February 1, 2021

Results QC Date

September 5, 2025

Last Update Submit

November 19, 2025

Conditions

Congenital Heart Disease

Keywords

resilienceadult congenital heart diseasestress managementadvance care planning

Outcome Measures

Primary Outcomes (2)

  • Feasibility of Enrollment

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

    3 months

  • Feasibility of PRISM

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

    3 months

Secondary Outcomes (1)

  • Mean Resilience

    3 months

Other Outcomes (7)

  • Health-Related Quality of Life

    3 months

  • Health-Related Quality of Life - VAS

    3 months

  • Quality of Life - LAS

    3 months

  • +4 more other outcomes

Study Arms (2)

PRISM Intervention

EXPERIMENTAL

Subjects in this group will receive the PRISM intervention

Behavioral: Promoting Resilience in Stress Management (PRISM)

Usual Care

PLACEBO COMPARATOR

Subjects in this arm will receive usual care

Other: Usual Care

Interventions

Promoting Resilience in Stress Management (PRISM)BEHAVIORAL

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

PRISM Intervention
Usual CareOTHER

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

Usual Care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • adults with moderate or complex ACHD, stages B, C, or D as defined by the 2018 ACHD guidelines
  • receive care in our health system

You may not qualify if:

  • diagnosis of another life-limiting illness
  • inability to participate in study activities independently and in English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Washington

Seattle, Washington, 98195, United States

Location

Related Publications (2)

  • 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.

    PMID: 40945428DERIVED

  • 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.

    PMID: 39047811DERIVED

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Limitations and Caveats

* Dingle-site study, serving a patient population which is less racially and ethnically diverse and more highly educated than the general ACHD population. * Decisions for a UC comparator group and to stop enrolling prior to contacting all eligible screened patients were practical decisions * Minimally clinical important difference data is not available for these tools in ACHD * Only evaluated intervention affect after 3 months

Results Point of Contact

Title
Jill Steiner
Organization
University of Washington
jills8@uw.edu
2062218240

Study Officials

  • Jill M Steiner, MD,MS

    University of Washington

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, School of Medicine

Study Record Dates

First Submitted

February 1, 2021

First Posted

February 4, 2021

Study Start

March 15, 2023

Primary Completion

July 25, 2024

Study Completion

July 25, 2024

Last Updated

December 15, 2025

Results First Posted

October 30, 2025

Record last verified: 2025-11

Locations

US(1)