Congenital Heart Disease
Conditions
Keywords
resilience, adult congenital heart disease, stress management, advance care planning
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.
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.
Interventions
Develops personal resilience resources through 1:1 sessions with a PRISM coach.
OTHERUsual Care
No additional study-specific interaction with subjects. Subjects continue to receive usual medical care.
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
University of Washington
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* adults with moderate or complex ACHD, stages B, C, or D as defined by the 2018 ACHD guidelines * receive care in our health system
Exclusion criteria
* diagnosis of another life-limiting illness * inability to participate in study activities independently and in English
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of Enrollment | 3 months | The proportion of patients who enroll in the study among those eligible during the recruitment period |
| Feasibility of PRISM | 3 months | The proportion of patients who complete the PRISM intervention among those randomized to intervention. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Resilience | 3 months | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Psychological Distress | 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.) |
| Competence in Managing Healthcare | 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. |
| Health-Related Quality of Life | 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. |
| Comfort With Advance Care Planning, With Doctor | 3 months | — |
| Comfort With Advance Care Planning, With Family | 3 months | — |
| Health-Related Quality of Life - VAS | 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. |
| Quality of Life - LAS | 3 months | Single-item assessment of quality of life, continuous 0-100 scale where 100 indicates perfect quality of life. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
Enrolled participants will complete the baseline survey prior to randomization.
Participants by arm
| Arm | Count |
|---|---|
| PRISM Intervention Subjects in this group will receive the PRISM intervention | 40 |
| Usual Care Subjects in this arm will receive usual care | 38 |
| Total | 78 |
Baseline characteristics
| Characteristic | Total | PRISM Intervention | Usual Care |
|---|---|---|---|
| ACHD Anatomy Severity Complex | 27 Participants | 12 Participants | 15 Participants |
| ACHD Anatomy Severity Moderate | 51 Participants | 28 Participants | 23 Participants |
| ACHD Physiology Severity C | 76 Participants | 39 Participants | 37 Participants |
| ACHD Physiology Severity D | 2 Participants | 1 Participants | 1 Participants |
| Age, Continuous | 38 years STANDARD_DEVIATION 12 | 36 years STANDARD_DEVIATION 11 | 40 years STANDARD_DEVIATION 12 |
| Education College | 9 Participants | 2 Participants | 7 Participants |
| Education Graduate School | 23 Participants | 14 Participants | 9 Participants |
| Education High School/GED | 15 Participants | 5 Participants | 10 Participants |
| Education Unknown | 31 Participants | 19 Participants | 12 Participants |
| Employment Employed | 56 Participants | 30 Participants | 26 Participants |
| Employment Out of Work | 15 Participants | 7 Participants | 8 Participants |
| Employment Student | 5 Participants | 1 Participants | 4 Participants |
| Employment Uknown | 2 Participants | 2 Participants | 0 Participants |
| Marital Status Divorced/Separated | 4 Participants | 4 Participants | 0 Participants |
| Marital Status Married | 48 Participants | 24 Participants | 24 Participants |
| Marital Status Single | 22 Participants | 9 Participants | 13 Participants |
| Marital Status Unknown | 3 Participants | 3 Participants | 0 Participants |
| Marital Status Widowed | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized AIAN | 2 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Asian | 9 Participants | 5 Participants | 4 Participants |
| Race/Ethnicity, Customized Black/African/African American | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Hispanic/Latino | 5 Participants | 5 Participants | 0 Participants |
| Race/Ethnicity, Customized Unknown | 8 Participants | 6 Participants | 2 Participants |
| Race/Ethnicity, Customized White | 53 Participants | 23 Participants | 30 Participants |
| Sex/Gender, Customized Gender Female | 48 Participants | 20 Participants | 28 Participants |
| Sex/Gender, Customized Gender Male | 25 Participants | 16 Participants | 9 Participants |
| Sex/Gender, Customized Gender Other | 5 Participants | 4 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 40 | 0 / 38 |
| other Total, other adverse events | 0 / 40 | 0 / 38 |
| serious Total, serious adverse events | 0 / 40 | 0 / 38 |
Outcome results
Primary
Feasibility of Enrollment
The proportion of patients who enroll in the study among those eligible during the recruitment period
Time frame: 3 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PRISM Intervention | Feasibility of Enrollment | 40 Participants |
| Usual Care | Feasibility of Enrollment | 38 Participants |
Primary
Feasibility of PRISM
The proportion of patients who complete the PRISM intervention among those randomized to intervention.
Time frame: 3 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PRISM Intervention | Feasibility of PRISM | 32 Participants |
| Usual Care | Feasibility of PRISM | 35 Participants |
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.
Time frame: 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).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PRISM Intervention | Mean Resilience | 30.1 Points | Standard Deviation 8.1 |
| Usual Care | Mean Resilience | 28.7 Points | Standard Deviation 5.8 |
Other Pre-specified
Comfort With Advance Care Planning, With Doctor
Time frame: 3 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PRISM Intervention | Comfort With Advance Care Planning, With Doctor | 0.5 Proportion of participants |
| Usual Care | Comfort With Advance Care Planning, With Doctor | 0.6 Proportion of participants |
Other Pre-specified
Comfort With Advance Care Planning, With Family
Time frame: 3 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PRISM Intervention | Comfort With Advance Care Planning, With Family | 0.4 Proportion of participants |
| Usual Care | Comfort With Advance Care Planning, With Family | 0.4 Proportion of participants |
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.
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PRISM Intervention | Competence in Managing Healthcare | 5.0 Points | Standard Deviation 0.9 |
| Usual Care | Competence in Managing Healthcare | 5.0 Points | Standard Deviation 1.1 |
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.
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PRISM Intervention | Health-Related Quality of Life | 0.9 points | Standard Deviation 0.2 |
| Usual Care | Health-Related Quality of Life | 0.8 points | Standard Deviation 0.2 |
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.
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PRISM Intervention | Health-Related Quality of Life - VAS | 59 points | Standard Deviation 14 |
| Usual Care | Health-Related Quality of Life - VAS | 73 points | Standard Deviation 14 |
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.)
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PRISM Intervention | Psychological Distress | 5.4 Points | Standard Deviation 4.7 |
| Usual Care | Psychological Distress | 5.2 Points | Standard Deviation 4.1 |
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.
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PRISM Intervention | Quality of Life - LAS | 83 Points | Standard Deviation 12 |
| Usual Care | Quality of Life - LAS | 79 Points | Standard Deviation 11 |