Assessment of Patterns of Patient Reported Outcomes in Adults With Congenital Heart Disease - International Study II
- Conditions
- Congenital Heart Disease
- Registration Number
- NCT04902768
- Lead Sponsor
- KU Leuven
- Brief Summary
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
The research aims of this study are:
1. 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").
2. 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").
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 8415
- 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
- Prior heart transplantation
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Patient-reported health status Baseline 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).
Patients' perception of providers' autonomy support Baseline 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.
Patient-reported quality of life Baseline 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).
Cognitive functioning Baseline This outcome is measured using the Montreal Cognitive Assessment Screener (MoCA). Scores range from 0 to 30. Scores of \<26 indicate cognitive dysfunction.
Patient-reported depressive symptoms Baseline This outcomes is measured using the Patient Health Questionnaire 8. Scores range from 0 to 24. Scores of ≥10 indicate depression.
Patient-reported anxiety symptoms Baseline 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.
Frailty phenotype Baseline 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).
- Secondary Outcome Measures
Name Time Method Patient-reported empowerment Baseline 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.
Patient-reported social support Baseline 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.
Advance care planning Baseline 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?'.
Patient-reported stigma Baseline 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.
Patient-reported illness identity Baseline 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.
Patient-reported parental involvement Baseline 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.
Patient-reported social media to connect with peers Baseline 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?'.
Medical variables by chart review (eg. diagnosis, cardiac surgeries) Baseline This outcome is classified according to the adult congenital heart disease anatomic and physiological (ACHD AP) classification system of Stout and colleagues.
Patient-reported healthcare utilization Baseline This outcomes was measured using the Patient-Reported Inpatient and outpatient Utilization Survey (PRIUS). Higher numbers indicate more healthcare use.
Patient-reported functional status Baseline This outcome is classified according to the New York Heart Association (NYHA).
Patient-reported socio-demographic variables (eg. age, educational level) Baseline Self-reported
Presence and burden of comorbidities Baseline This outcome is measured using the Charlson Comorbidity Index.
Trial Locations
- Locations (53)
University of California
🇺🇸San Francisco, California, United States
Lucile Packard Children's Hospital and Stanford Health Care
🇺🇸Stanford, California, United States
University of Florida Health
🇺🇸Gainesville, Florida, United States
Taussig Heart Center of Johns Hopkins Hospital
🇺🇸Baltimore, Maryland, United States
Boston Children's / Brigham and Women's
🇺🇸Boston, Massachusetts, United States
Mount Sinai Heart
🇺🇸New York, New York, United States
Nationwide Children's Hospital
🇺🇸Columbus, Ohio, United States
Oregon Health and Science University
🇺🇸Portland, Oregon, United States
Philadelphia Penn Medicine
🇺🇸Philadelphia, Pennsylvania, United States
University of Southwestern Medical Center
🇺🇸Dallas, Texas, United States
Scroll for more (43 remaining)University of California🇺🇸San Francisco, California, United States