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| ID | Type | Description | Link |
|---|---|---|---|
| K23HL151801-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PRISM Intervention | Experimental | Subjects in this group will receive the PRISM intervention |
|
| Usual Care | Placebo Comparator | Subjects in this arm will receive usual care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Promoting Resilience in Stress Management (PRISM) | Behavioral | Develops personal "resilience resources" through 1:1 sessions with a PRISM coach. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Health-Related Quality of Life | EuroQOL 5D-3L: 6-item measurement of health-related quality of life. The first 5 questions ask about symptoms and any health-related limitations. Each of these 5 items is scored on a 3-point scale, yielding a 5-digit number which can be indexed according to country (for the United States, values are -0.11 to 1). Higher scores indicate better quality of life. | 3 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jill M Steiner, MD,MS | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Washington | Seattle | Washington | 98195 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40945428 | Derived | 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. | |
| 39047811 | Derived | 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. |
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Enrolled participants will complete the baseline survey prior to randomization.
Research Coordinator (RC) will screen electronic patient lists for ACHD outpatient clinics to identify potential study participants.
RC will contact eligible patients (telephone and email), explain the study, and assess interest in participation using study team written and approved recruitment scripts.
If agreeable, patients will be enrolled into the study. RC will obtain informed consent.
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| ID | Title | Description |
|---|---|---|
| FG000 | PRISM Intervention | Subjects in this group will receive the PRISM intervention. The intervention consists of a series of 5 standardized modules (plus one optional family meeting) delivered verbally in a 1:1 fashion via teleconference, roughly one every 2 weeks. |
| FG001 | Usual Care | Subjects in this arm will receive usual care |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | PRISM Intervention | Subjects in this group will receive the PRISM intervention |
| BG001 | Usual Care | Subjects in this arm will receive usual care |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Feasibility of Enrollment | The proportion of patients who enroll in the study among those eligible during the recruitment period | Posted | Count of Participants | Participants | 3 months |
|
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From enrollment until end of follow-up, up to 6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PRISM Intervention | Subjects in this group will receive the PRISM intervention |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jill Steiner | University of Washington | 2062218240 | jills8@uw.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 5, 2025 | Sep 5, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006330 | Heart Defects, Congenital |
| ID | Term |
|---|---|
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
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| Usual Care | Other | No additional study-specific interaction with subjects. Subjects continue to receive usual medical care. |
|
| 3 months |
| Health-Related Quality of Life - VAS | EuroQOL 5D-3L Visual Analog Scale (VAS). The final question in EuroQOL asks about health status on a visual analog scale, 0-100, where 100 is perfect health. | 3 months |
| Quality of Life - LAS | Single-item assessment of quality of life, continuous 0-100 scale where 100 indicates perfect quality of life. | 3 months |
| Psychological Distress | Kessler-6 Psychological Distress Scale (K-6: 6-item inventory measuring the level of global psychological distress. Symptoms are rated on a 5-point scale, scored from 0-4, with an overall range of 0 to 24 points. Higher scores reflect greater distress, with scores >6 suggesting "high" distress and scores >12 suggesting "serious" distress.) | 3 months |
| Competence in Managing Healthcare | Perceived Competence Scale (PCS): 4-item tool that asks about competence in managing one's disease process. Each item consists of a 7-point scale, ranging from 1 "Not at all true" to 7 "Very true." The tool is scored by calculating the mean response across all 4 questions (range 1-7). Higher scores indicate higher perceived competence. | 3 months |
| Comfort With Advance Care Planning, With Family | 3 months |
| Comfort With Advance Care Planning, With Doctor | 3 months |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Education | Count of Participants | Participants |
|
| Employment | Count of Participants | Participants |
|
| Marital Status | Count of Participants | Participants |
|
| ACHD Anatomy Severity | Count of Participants | Participants |
|
| ACHD Physiology Severity | Based on the ACHD Anatomy/Physiology classification as described in the 2018 Guidelines for the Care of Adults with Congenital Heart Disease; graded A-D where A is least severe physiologic impacts and D is worst. | Count of Participants | Participants |
|
| Participants |
|
|
| Primary | Feasibility of PRISM | The proportion of patients who complete the PRISM intervention among those randomized to intervention. | Posted | Count of Participants | Participants | 3 months |
|
|
|
| Secondary | 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. | The difference between number of participants assigned versus here reflects dropout over the course of the study. Since our first intention was to describe feasibility, we used the enrolled numbers (40 and 38, respectively) in descriptive data analysis. For the resilience analysis, we analyzed only those with baseline and 3 months data (30 and 35, respectively). | Posted | Mean | Standard Deviation | Points | 3 months |
|
|
|
| Other Pre-specified | Health-Related Quality of Life | EuroQOL 5D-3L: 6-item measurement of health-related quality of life. The first 5 questions ask about symptoms and any health-related limitations. Each of these 5 items is scored on a 3-point scale, yielding a 5-digit number which can be indexed according to country (for the United States, values are -0.11 to 1). Higher scores indicate better quality of life. | Posted | Mean | Standard Deviation | points | 3 months |
|
|
|
| Other Pre-specified | Health-Related Quality of Life - VAS | EuroQOL 5D-3L Visual Analog Scale (VAS). The final question in EuroQOL asks about health status on a visual analog scale, 0-100, where 100 is perfect health. | Posted | Mean | Standard Deviation | points | 3 months |
|
|
|
| Other Pre-specified | Quality of Life - LAS | Single-item assessment of quality of life, continuous 0-100 scale where 100 indicates perfect quality of life. | Posted | Mean | Standard Deviation | Points | 3 months |
|
|
|
| Other Pre-specified | Psychological Distress | Kessler-6 Psychological Distress Scale (K-6: 6-item inventory measuring the level of global psychological distress. Symptoms are rated on a 5-point scale, scored from 0-4, with an overall range of 0 to 24 points. Higher scores reflect greater distress, with scores >6 suggesting "high" distress and scores >12 suggesting "serious" distress.) | Posted | Mean | Standard Deviation | Points | 3 months |
|
|
|
| Other Pre-specified | Competence in Managing Healthcare | Perceived Competence Scale (PCS): 4-item tool that asks about competence in managing one's disease process. Each item consists of a 7-point scale, ranging from 1 "Not at all true" to 7 "Very true." The tool is scored by calculating the mean response across all 4 questions (range 1-7). Higher scores indicate higher perceived competence. | Posted | Mean | Standard Deviation | Points | 3 months |
|
|
|
| Other Pre-specified | Comfort With Advance Care Planning, With Family | Posted | Number | Proportion of participants | 3 months |
|
|
|
| Other Pre-specified | Comfort With Advance Care Planning, With Doctor | Posted | Number | Proportion of participants | 3 months |
|
|
|
| 0 |
| 40 |
| 0 |
| 40 |
| 0 |
| 40 |
| EG001 | Usual Care | Subjects in this arm will receive usual care | 0 | 38 | 0 | 38 | 0 | 38 |
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| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |