Assessment of Patterns of Patient Reported Outcomes in Adults With Congenital Heart Disease - International Study II

Study Overview
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Brief Summary
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This is an international, cross-sectional and descriptive study that aims to investigate differences in patient-reported outcome measures (PROMs) and patient-reported experience measures (PREMs) and that aims to explore the profile and healthcare needs of adults with congenital heart diseases.

Detailed Description
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The research aims of this study are: To further explore differences in a modified selection of patient-reported outcome measures (PROMs) and (as a new addition in APPROACH-IS II) explore differences in patient-reported experience measures (PREMs), by enrolling adults with congenital heart diseases in low, middle, and high income countries and including new potential explanatory variables (Part 1). To explore the profile and healthcare needs of a subgroup of older adults with congenital heart disease, with a particular focus on investigating the frailty phenotype (Part 2).

Official Title
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APPROACH-IS II: Assessment of Patterns of Patient Reported Outcomes in Adults With Congenital Heart Disease - International Study II

Conditions
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Congenital Heart Disease

Intervention / Treatment
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* Other: This is an observational study, there is no intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed with congenital heart disease, defined as: a gross structural abnormality of the heart and/or intra-thoracic great vessels that is actually or potentially of functional significance (including mild, moderate, and complex heart defects) Aged 18 years of age or older at the moment of study inclusion Diagnosed with congenital heart disease before the age of 10 years Follow-up at an ACHD center or included in a national/regional registry Physical, cognitive, and language abilities to complete self-report questionnaires Exclusion Criteria: - Prior heart transplantation

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Adults with congenital heart disease<br> | Other: This is an observational study, there is no intervention<br>* This is an observational study, there is no intervention. Hence, this is not applicable.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient-reported health status | This outcome is measured using the shortened version of the RAND-36. Composite physical (PCS) and mental health (MCS) scores are computed. Scores range from 0 (lowest health level) to 100 (highest health level). | Baseline | 
| Patient-reported health status | This outcome is measured using the Linear Analogue Scale Health Status (LAS HS). Scores range from 0 (worst imaginable health state) to 100 (best imaginable health state). | Baseline | 
| Patient-reported depressive symptoms | This outcomes is measured using the Patient Health Questionnaire 8. Scores range from 0 to 24. Scores of ≥10 indicate depression. | Baseline | 
| Patient-reported anxiety symptoms | This outcome is measured using the General Anxiety Disorder 7. Scores range from 0 to 21. Scores of 5, 10, and 15 are taken as cut-off points for mild, moderate and severe anxiety. | Baseline | 
| Patient-reported quality of life | This outcome is measured using the Linear Analog Scale on Quality of Life (LAS QOL). Scores range from 0 (worst imaginable quality of life) to 100 (best imaginable quality of life). | Baseline | 
| Patients' perception of providers' autonomy support | This outcome is measured using the modified Health Care Climate Questionnaire (mHCCQ). Each of the 6 items is scored from 1 to 7. Scores are calculated by averaging the individual item scores. Higher average score represents a higher level of perceived autonomy support. | Baseline | 
| Cognitive functioning | This outcome is measured using the Montreal Cognitive Assessment Screener (MoCA). Scores range from 0 to 30. Scores of <26 indicate cognitive dysfunction. | Baseline | 
| Frailty phenotype | This outcome is classified using the Fried method (i.e., non-frail (no positive criterion), pre-frail (1 or 2 criteria positive), or frail (when ≥3 criteria are positive). | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient-reported stigma | This outcome is measured using the Chronic Illness Stigma Scale (CISS). Scores range from 8 to 40. Higher scores indicating higher levels of perceived stigma. | Baseline | 
| Patient-reported illness identity | This outcome is measured using the Illness Identity Questionnaire (IIQ). The questionnaire consists of a five-item rejection scale, seven-item enrichment scale, five-item acceptance scale and eight-item engulfment scale. A mean score is calculated per subscale. Higher scores indicate more rejection, enrichment, acceptance or engulfment. | Baseline | 
| Patient-reported empowerment | This outcome is measured using the Gothenburg Empowerment Scale (GES generic v1.1). Scores range from 15 to 75. Higher score reflects a higher level of empowerment. | Baseline | 
| Patient-reported healthcare utilization | This outcomes was measured using the Patient-Reported Inpatient and outpatient Utilization Survey (PRIUS). Higher numbers indicate more healthcare use. | Baseline | 
| Patient-reported functional status | This outcome is classified according to the New York Heart Association (NYHA). | Baseline | 
| Patient-reported social support | This outcomes is measured using the Multidimensional Scale on Perceived Social Support Scale (MSPSS). Scores range from 12 to 84. Higher score indicates greater social support perceived by an individual. | Baseline | 
| Patient-reported parental involvement | This outcome is measured using an adapted version of the subscale on parents of the Multidimensional Scale on Perceived Social Support. Scores range from 5 to 35. Higher score indicates greater parental support in childhood and adolescence. | Baseline | 
| Advance care planning | This outcome is measured using a survey developed for APPROACH-IS II by the Steering Committee, based on previous research. A sample question is 'Have you personally written down information about the care you would want in case you become seriously ill in the future?'. | Baseline | 
| Patient-reported social media to connect with peers | This outcome is measured using a survey developed for APPROACH-IS II by the Steering Committee, based on previous research. A sample question is 'How would you describe your experiences connecting with other people with CHD through social media?'. | Baseline | 
| Presence and burden of comorbidities | This outcome is measured using the Charlson Comorbidity Index. | Baseline | 
| Patient-reported socio-demographic variables (eg. age, educational level) | Self-reported | Baseline | 
| Medical variables by chart review (eg. diagnosis, cardiac surgeries) | This outcome is classified according to the adult congenital heart disease anatomic and physiological (ACHD AP) classification system of Stout and colleagues. | Baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Congenital Heart Disease, Quality of life, Patient reported outcomes, Patient reported experience measures, Geriatric phenotype