Trial Outcomes & Findings for Assessing and Promoting Resilience in Patients With Adult Congenital Heart Disease (NCT NCT04738474)

NCT ID: NCT04738474

Last Updated: 2025-12-15

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 78 participants
• Primary outcome timeframe: 3 months
• Results posted on: 2025-12-15

Participant Flow

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.

Enrolled participants will complete the baseline survey prior to randomization.

Participant milestones

Measure	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.	Usual Care Subjects in this arm will receive usual care
Overall Study STARTED	40	38
Overall Study COMPLETED	32	35
Overall Study NOT COMPLETED	8	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Assessing and Promoting Resilience in Patients With Adult Congenital Heart Disease

Baseline characteristics by cohort

Measure	PRISM Intervention n=40 Participants Subjects in this group will receive the PRISM intervention	Usual Care n=38 Participants Subjects in this arm will receive usual care	Total n=78 Participants Total of all reporting groups
Age, Continuous	36 years STANDARD_DEVIATION 11 • n=6009 Participants	40 years STANDARD_DEVIATION 12 • n=42 Participants	38 years STANDARD_DEVIATION 12 • n=77 Participants
Sex/Gender, Customized Gender · Female	20 Participants n=6009 Participants	28 Participants n=42 Participants	48 Participants n=77 Participants
Sex/Gender, Customized Gender · Male	16 Participants n=6009 Participants	9 Participants n=42 Participants	25 Participants n=77 Participants
Sex/Gender, Customized Gender · Other	4 Participants n=6009 Participants	1 Participants n=42 Participants	5 Participants n=77 Participants
Race/Ethnicity, Customized White	23 Participants n=6009 Participants	30 Participants n=42 Participants	53 Participants n=77 Participants
Race/Ethnicity, Customized Asian	5 Participants n=6009 Participants	4 Participants n=42 Participants	9 Participants n=77 Participants
Race/Ethnicity, Customized AIAN	1 Participants n=6009 Participants	1 Participants n=42 Participants	2 Participants n=77 Participants
Race/Ethnicity, Customized Black/African/African American	0 Participants n=6009 Participants	1 Participants n=42 Participants	1 Participants n=77 Participants
Race/Ethnicity, Customized Hispanic/Latino	5 Participants n=6009 Participants	0 Participants n=42 Participants	5 Participants n=77 Participants
Race/Ethnicity, Customized Unknown	6 Participants n=6009 Participants	2 Participants n=42 Participants	8 Participants n=77 Participants
Education High School/GED	5 Participants n=6009 Participants	10 Participants n=42 Participants	15 Participants n=77 Participants
Education Graduate School	14 Participants n=6009 Participants	9 Participants n=42 Participants	23 Participants n=77 Participants
Education College	2 Participants n=6009 Participants	7 Participants n=42 Participants	9 Participants n=77 Participants
Education Unknown	19 Participants n=6009 Participants	12 Participants n=42 Participants	31 Participants n=77 Participants
Employment Employed	30 Participants n=6009 Participants	26 Participants n=42 Participants	56 Participants n=77 Participants
Employment Out of Work	7 Participants n=6009 Participants	8 Participants n=42 Participants	15 Participants n=77 Participants
Employment Student	1 Participants n=6009 Participants	4 Participants n=42 Participants	5 Participants n=77 Participants
Employment Uknown	2 Participants n=6009 Participants	0 Participants n=42 Participants	2 Participants n=77 Participants
Marital Status Married	24 Participants n=6009 Participants	24 Participants n=42 Participants	48 Participants n=77 Participants
Marital Status Single	9 Participants n=6009 Participants	13 Participants n=42 Participants	22 Participants n=77 Participants
Marital Status Widowed	0 Participants n=6009 Participants	1 Participants n=42 Participants	1 Participants n=77 Participants
Marital Status Divorced/Separated	4 Participants n=6009 Participants	0 Participants n=42 Participants	4 Participants n=77 Participants
Marital Status Unknown	3 Participants n=6009 Participants	0 Participants n=42 Participants	3 Participants n=77 Participants
ACHD Anatomy Severity Moderate	28 Participants n=6009 Participants	23 Participants n=42 Participants	51 Participants n=77 Participants
ACHD Anatomy Severity Complex	12 Participants n=6009 Participants	15 Participants n=42 Participants	27 Participants n=77 Participants
ACHD Physiology Severity C	39 Participants n=6009 Participants	37 Participants n=42 Participants	76 Participants n=77 Participants
ACHD Physiology Severity D	1 Participants n=6009 Participants	1 Participants n=42 Participants	2 Participants n=77 Participants

PRIMARY outcome

Timeframe: 3 months

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

Outcome measures

Measure	PRISM Intervention n=40 Participants Subjects in this group will receive the PRISM intervention	Usual Care n=38 Participants Subjects in this arm will receive usual care
Feasibility of Enrollment	40 Participants	38 Participants

PRIMARY outcome

Timeframe: 3 months

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

Outcome measures

Measure	PRISM Intervention n=40 Participants Subjects in this group will receive the PRISM intervention	Usual Care n=38 Participants Subjects in this arm will receive usual care
Feasibility of PRISM	32 Participants	35 Participants

SECONDARY outcome

Timeframe: 3 months

Population: 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).

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.

Outcome measures

Measure	PRISM Intervention n=30 Participants Subjects in this group will receive the PRISM intervention	Usual Care n=35 Participants Subjects in this arm will receive usual care
Mean Resilience	30.1 Points Standard Deviation 8.1	28.7 Points Standard Deviation 5.8

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 months

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.

Outcome measures

Measure	PRISM Intervention n=31 Participants Subjects in this group will receive the PRISM intervention	Usual Care n=35 Participants Subjects in this arm will receive usual care
Health-Related Quality of Life	0.9 points Standard Deviation 0.2	0.8 points Standard Deviation 0.2

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 months

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.

Outcome measures

Measure	PRISM Intervention n=31 Participants Subjects in this group will receive the PRISM intervention	Usual Care n=35 Participants Subjects in this arm will receive usual care
Health-Related Quality of Life - VAS	59 points Standard Deviation 14	73 points Standard Deviation 14

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 months

Single-item assessment of quality of life, continuous 0-100 scale where 100 indicates perfect quality of life.

Outcome measures

Measure	PRISM Intervention n=31 Participants Subjects in this group will receive the PRISM intervention	Usual Care n=31 Participants Subjects in this arm will receive usual care
Quality of Life - LAS	83 Points Standard Deviation 12	79 Points Standard Deviation 11

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 months

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.)

Outcome measures

Measure	PRISM Intervention n=30 Participants Subjects in this group will receive the PRISM intervention	Usual Care n=34 Participants Subjects in this arm will receive usual care
Psychological Distress	5.4 Points Standard Deviation 4.7	5.2 Points Standard Deviation 4.1

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 months

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.

Outcome measures

Measure	PRISM Intervention n=31 Participants Subjects in this group will receive the PRISM intervention	Usual Care n=35 Participants Subjects in this arm will receive usual care
Competence in Managing Healthcare	5.0 Points Standard Deviation 0.9	5.0 Points Standard Deviation 1.1

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 months

Outcome measures

Measure	PRISM Intervention n=31 Participants Subjects in this group will receive the PRISM intervention	Usual Care n=35 Participants Subjects in this arm will receive usual care
Comfort With Advance Care Planning, With Family	0.4 Proportion of participants	0.4 Proportion of participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 months

Outcome measures

Measure	PRISM Intervention n=31 Participants Subjects in this group will receive the PRISM intervention	Usual Care n=35 Participants Subjects in this arm will receive usual care
Comfort With Advance Care Planning, With Doctor	0.5 Proportion of participants	0.6 Proportion of participants

Adverse Events

PRISM Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Usual Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jill Steiner

University of Washington

Phone: 2062218240

Email: jills8@uw.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place