An observational study in Congenital Heart Disease, sponsored by KU Leuven. Completed at 53 sites in 32 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-16.
Sponsored by KU Leuven · Observational
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.
The research aims of this study are:
991 studies on the registry are indexed under Heart Defects, Congenital; 251 are open to participants now.
This study's enrollment of 8,415 is above the median of 119 across 440 observational studies indexed under Heart Defects, Congenital.
Browse Heart Defects, Congenital studies →KU Leuven is the lead sponsor of 373 studies on the registry; 65 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adults with congenital heart disease who are in follow-up at an adult congenital heart disease center or included in a national/regional registry.
For Part 1 of this study, each participating center will aim to recruit 200 adult patients with CHD aged 18 years or older with simple, moderate, or complex congenital heart disease. For Part 2 of this study, within these samples of 200 patients, centers will aim to recruit about 20 adults aged 40-50y, 20 adults aged 50-60y and 20 adults aged >60 years who are diagnosed with moderate to great disease complexity.
Depending on the data collection method, sampling is at random or consecutive. Both a probability and convenience sample can be used.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Other: This is an observational study, there is no intervention
This is an observational study, there is no intervention. Hence, this is not applicable.
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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: Baseline
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline
Patient-reported functional status
This outcome is classified according to the New York Heart Association (NYHA).
Time frame: 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.
Time frame: 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.
Time frame: 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?'.
Time frame: 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?'.
Time frame: Baseline
Presence and burden of comorbidities
This outcome is measured using the Charlson Comorbidity Index.
Time frame: Baseline
Patient-reported socio-demographic variables (eg. age, educational level)
Self-reported
Time frame: 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.
Time frame: Baseline
Plan to share: No — Well-argued and reasonable requests can be directed to the Principal Investigator (Prof. Philip Moons) of the study.
Ran from Aug 2019 to primary completion in Aug 2022, 36 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.