Evidence map›Paper›PMID 39047811›Full record

ArticleContemporary clinical trials2024

Rationale and design of a randomized controlled clinical trial of a resilience-building intervention in adults with congenital heart disease.

Jill M Steiner, Arisa Rei Marshall, Adrienne H Kovacs, Ruth A Engelberg, Lyndia Brumback, Karen K Stout, Chris T Longenecker, Joyce P Yi-Frazier, Abby R Rosenberg

Registry-linked trialAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Contemporary clinical trials, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04738474 (Assessing and Promoting Resilience in Patients With Adult Congenital Heart Disease), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04738474 nacompletednot on this map

Assessing and Promoting Resilience in Patients With Adult Congenital Heart Disease

TypeinterventionalSponsorUniversity of WashingtonRan2023 to 2024Enrolled78ConditionsCongenital Heart DiseaseArmsPromoting Resilience in Stress Management (PRISM), Usual Care
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

Jill M SteinerDivision of Cardiology, Department of Medicine & Cambia Palliative Care Center of Excellence, University of Washington, 1959 NE Pacific St., Seattle, WA 98195, USA. Electronic address: jills8@uw.edu.
Arisa Rei MarshallDivision of Cardiology, Department of Medicine, University of Washington, 1959 NE Pacific St., Seattle, WA 98195, USA.
Adrienne H KovacsEquilibria Psychological Health, 10-255 The East Mall, Toronto, Ontario M9B 0A9, Canada.
Ruth A EngelbergDivision of Pulmonary, Critical Care and Sleep Medicine, Department of Medicine & Cambia Palliative Care Center of Excellence, University of Washington, Harborview Medical Center, 325 9th Ave, Seattle, WA 98104, USA.
Lyndia BrumbackDepartment of Biostatistics, University of Washington, 1959 NE Pacific St., Seattle, WA 98195, USA.
Karen K StoutDivision of Cardiology, Department of Medicine, University of Washington, 1959 NE Pacific St., Seattle, WA 98195, USA.
Chris T LongeneckerDivision of Cardiology and Department of Global Health, University of Washington, 3980 15th Ave NE, Seattle, WA 98105, USA.
Joyce P Yi-FrazierCenter for Clinical and Translational Research, Seattle Children's Research Institute, 1920 Terry Ave, Seattle, WA 98101, USA; Department of Psychosocial Oncology and Palliative Care, Dana-Farber Cancer Institute & Department of Pediatrics, Harvard Medical School; 450 Brookline Ave, Boston, MA 02215, USA.
Abby R RosenbergDepartment of Psychosocial Oncology and Palliative Care, Dana-Farber Cancer Institute & Department of Pediatrics, Harvard Medical School; 450 Brookline Ave, Boston, MA 02215, USA.

Funding

Transform Dissemination and Implementation Science in CTSA ProgramsUL1TR002319 · NCATS · UNIVERSITY OF WASHINGTON · PI John K. Amory · 2017 to 2026
$100.0M
Assessing and Promoting Resilience in Adults with Adult Congenital Heart DiseaseK23HL151801 · NHLBI · UNIVERSITY OF WASHINGTON · PI STEINER, JILL MARIE · 2021 to 2025
$920k
NCATS NIH HHS UL1 TR002319NHLBI NIH HHS K23 HL151801
6 · The paper itself

Abstract

backgroundAdults with congenital heart disease (ACHD) are at risk for lower quality of life (QOL) and psychological health. Behavioral interventions to meet their psychosocial needs are lacking. The aim of this study is to evaluate the feasibility of implementing the Promoting Resilience in Stress Management (PRISM) intervention in ACHD and its efficacy in increasing resilience in this population.

methodsWe designed a phase II randomized controlled clinical trial of patients with moderate or complex ACHD, physiological stages C or D. Enrolled participants will be randomized to receive PRISM or usual care. PRISM is a manualized, skills-based behavioral intervention comprised of four one-on-one sessions targeting resilience resources (stress-management, goal-setting, cognitive reframing, meaning making), an optional session on advance care planning, and a facilitated family meeting. Participants in both groups will complete study questionnaires at enrollment and 3-months later. The primary aim is to describe feasibility, namely the proportions of patients who a) enroll in the study among those eligible, and b) complete the PRISM intervention among those randomized to that arm. We will also evaluate PRISM's efficacy by using linear regression models to compare changes in mean resilience scores between assigned groups. In exploratory analyses, we will evaluate effects on QOL, psychological distress, perceived competence for health care management, and comfort with advance care planning. DISCUSSION: This study will provide rigorous evidence to determine the feasibility and efficacy of a brief intervention to promote resilience and psychosocial health in ACHD. Findings may guide the development of a future multi-site effectiveness study. CLINICAL

trial registrationNCT04738474.

Indexed as

Heart Defects, CongenitalQuality of LifeResilience, PsychologicalAdultAdvance Care PlanningClinical Trials, Phase II as TopicCognitive Behavioral TherapyFeasibility StudiesFemaleGoalsHumansMalePsychosocial InterventionRandomized Controlled Trials as TopicResearch DesignStress, PsychologicalBehavioral interventionClinical trialCongenital heart diseaseQuality of lifeResilience

Identifiers

PMID39047811
PMCPMC11392615

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.