Congenital Heart DiseasePRISMACHDNCT04738474
Assessing and Promoting Resilience in Patients With Adult Congenital Heart Disease
A study testing Promoting Resilience in Stress Management (PRISM) in people with Congenital Heart Disease, run by University of Washington at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Congenital Heart Disease
- What is being tested?
- Promoting Resilience in Stress Management (PRISM)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 78 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Mar 2023to 25 Jul 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adults with moderate or complex ACHD, stages B, C, or D as defined by the 2018 ACHD guidelines
- receive care in our health system
Who cannot join
- diagnosis of another life-limiting illness
- inability to participate in study activities independently and in English
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed 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.
- Conditions
- Congenital Heart Disease
- Being tested
- Promoting Resilience in Stress Management (PRISM), Usual Care
- Keywords
- resilience, adult congenital heart disease, stress management, advance care planning
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Promoting Resilience in Stress Management (PRISM)Behavioural
Develops personal "resilience resources" through 1:1 sessions with a PRISM coach.
Usual CareOther
No additional study-specific interaction with subjects. Subjects continue to receive usual medical care.
| Study group | Role | What they receive |
|---|---|---|
| PRISM Intervention | Experimental | Subjects in this group will receive the PRISM intervention Receives: Behavioral: Promoting Resilience in Stress Management (PRISM) |
| Usual Care | Placebo comparator | Subjects in this arm will receive usual care Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of Enrollment
The proportion of patients who enroll in the study among those eligible during the recruitment period
Measured: 3 months
Feasibility of PRISM
The proportion of patients who complete the PRISM intervention among those randomized to intervention.
Measured: 3 months
Secondary outcomes (1)
Mean Resilience
Mean (SD) resilience scores (as defined by mean CDRISC-10 score) were compared between treatment and control groups at the end of the 3-month study period. Significance of treatment effect was evaluated using the change in mean resilience (difference between scores at 3 months vs baseline). 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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2021
- Study start15 Mar 2023
- Primary completion25 Jul 2024
- Study completion25 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Jill Steiner, University of Washington
- Investigators
- Jill M Steiner, MD,MS, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04738474
- Sponsor's protocol ID
- STUDY00008661
- Other IDs
- K23HL151801-01A1
- Acronym
- PRISMACHD
- Status last verified
- Nov 2025
- First submitted
- 1 Feb 2021
- Last updated
- 15 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40945428Steiner 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.
PubMed 39047811
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing and Promoting Resilience in Patients With Adult Congenital Heart Disease
- ClinicalTrials.gov ID
- NCT04738474
- Acronym / sponsor ID
- PRISMACHD / STUDY00008661
- Conditions
- Congenital Heart Disease
- Keywords
- resilience, adult congenital heart disease, stress management, advance care planning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 15 Mar 2023 (actual)
- Primary completion
- 25 Jul 2024 (actual)
- Study completion
- 25 Jul 2024 (actual)
- First posted
- 4 Feb 2021 (actual)
- Results
- Posted 30 Oct 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PRISM Intervention | Experimental | Behavioral: Promoting Resilience in Stress Management (PRISM)Subjects in this group will receive the PRISM intervention |
| Usual Care | Placebo comparator | Other: Usual CareSubjects in this arm will receive usual care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- adults with moderate or complex ACHD, stages B, C, or D as defined by the 2018 ACHD guidelines
- receive care in our health system
Key exclusion criteria (2 listed)
- diagnosis of another life-limiting illness
- inability to participate in study activities independently and in English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Promoting Resilience in Stress Management (PRISM)Develops personal "resilience resources" through 1:1 sessions with a PRISM coach. | Behavioural | PRISM Intervention |
| Usual CareNo additional study-specific interaction with subjects. Subjects continue to receive usual medical care. | Other | Usual Care |
Primary outcome
Feasibility of Enrollment
Time frame: 3 months
The proportion of patients who enroll in the study among those eligible during the recruitment period
Feasibility of PRISM
Time frame: 3 months
The proportion of patients who complete the PRISM intervention among those randomized to intervention.
1 secondary outcome
Mean Resilience
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40945428Steiner 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.
- Derived from this study: PubMed 39047811Steiner 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jill M Steiner, MD,MS principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Promoting Resilience in Stress Management (PRISM) in people with Congenital Heart Disease, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of Enrollment (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04738474, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2025.