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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04902768
Registration number
NCT04902768
Ethics application status
Date submitted
20/05/2021
Date registered
26/05/2021
Date last updated
16/05/2024
Titles & IDs
Public title
Assessment of Patterns of Patient Reported Outcomes in Adults With Congenital Heart Disease - International Study II
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Scientific title
APPROACH-IS II: Assessment of Patterns of Patient Reported Outcomes in Adults With Congenital Heart Disease - International Study II
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Secondary ID [1]
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S62537
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Universal Trial Number (UTN)
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Trial acronym
APPROACH-IS II
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Congenital Heart Disease
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Condition category
Condition code
Cardiovascular
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Coronary heart disease
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Cardiovascular
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Other cardiovascular diseases
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Human Genetics and Inherited Disorders
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0
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Other human genetics and inherited disorders
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Other interventions - This is an observational study, there is no intervention
Adults with congenital heart disease -
Other interventions: This is an observational study, there is no intervention
This is an observational study, there is no intervention. Hence, this is not applicable.
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Patient-reported health status
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Assessment method [1]
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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).
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Timepoint [1]
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Baseline
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Primary outcome [2]
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Patient-reported health status
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Assessment method [2]
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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).
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Timepoint [2]
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Baseline
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Primary outcome [3]
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Patient-reported depressive symptoms
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Assessment method [3]
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This outcomes is measured using the Patient Health Questionnaire 8. Scores range from 0 to 24. Scores of =10 indicate depression.
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Timepoint [3]
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Baseline
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Primary outcome [4]
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Patient-reported anxiety symptoms
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Assessment method [4]
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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.
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Timepoint [4]
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Baseline
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Primary outcome [5]
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Patient-reported quality of life
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Assessment method [5]
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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).
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Timepoint [5]
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Baseline
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Primary outcome [6]
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Patients' perception of providers' autonomy support
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Assessment method [6]
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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.
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Timepoint [6]
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Baseline
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Primary outcome [7]
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Cognitive functioning
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Assessment method [7]
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This outcome is measured using the Montreal Cognitive Assessment Screener (MoCA). Scores range from 0 to 30. Scores of <26 indicate cognitive dysfunction.
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Timepoint [7]
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Baseline
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Primary outcome [8]
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Frailty phenotype
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Assessment method [8]
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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).
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Timepoint [8]
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Baseline
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Secondary outcome [1]
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Patient-reported stigma
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Assessment method [1]
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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.
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Timepoint [1]
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Baseline
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Secondary outcome [2]
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Patient-reported illness identity
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Assessment method [2]
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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.
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Timepoint [2]
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Baseline
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Secondary outcome [3]
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Patient-reported empowerment
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Assessment method [3]
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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.
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Timepoint [3]
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Baseline
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Secondary outcome [4]
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Patient-reported healthcare utilization
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Assessment method [4]
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This outcomes was measured using the Patient-Reported Inpatient and outpatient Utilization Survey (PRIUS). Higher numbers indicate more healthcare use.
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Timepoint [4]
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Baseline
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Secondary outcome [5]
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Patient-reported functional status
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Assessment method [5]
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This outcome is classified according to the New York Heart Association (NYHA).
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Timepoint [5]
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Baseline
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Secondary outcome [6]
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Patient-reported social support
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Assessment method [6]
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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.
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Timepoint [6]
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Baseline
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Secondary outcome [7]
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Patient-reported parental involvement
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Assessment method [7]
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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.
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Timepoint [7]
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Baseline
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Secondary outcome [8]
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Advance care planning
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Assessment method [8]
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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?'.
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Timepoint [8]
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Baseline
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Secondary outcome [9]
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Patient-reported social media to connect with peers
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Assessment method [9]
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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?'.
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Timepoint [9]
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Baseline
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Secondary outcome [10]
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Presence and burden of comorbidities
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Assessment method [10]
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This outcome is measured using the Charlson Comorbidity Index.
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Timepoint [10]
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Baseline
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Secondary outcome [11]
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Patient-reported socio-demographic variables (eg. age, educational level)
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Assessment method [11]
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Self-reported
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Timepoint [11]
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Baseline
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Secondary outcome [12]
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Medical variables by chart review (eg. diagnosis, cardiac surgeries)
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Assessment method [12]
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This outcome is classified according to the adult congenital heart disease anatomic and physiological (ACHD AP) classification system of Stout and colleagues.
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Timepoint [12]
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Baseline
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Eligibility
Key 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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Prior heart transplantation
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Study design
Purpose
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Duration
Cross-sectional
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Selection
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Timing
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/08/2019
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
31/12/2022
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Sample size
Target
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Accrual to date
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Final
8415
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Melbourne Children's Cardiology - Melbourne
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Recruitment postcode(s) [1]
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- Melbourne
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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California
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United States of America
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State/province [2]
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Florida
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United States of America
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State/province [3]
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Maryland
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Country [4]
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United States of America
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State/province [4]
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Massachusetts
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Country [5]
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United States of America
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State/province [5]
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New York
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Country [6]
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United States of America
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State/province [6]
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Ohio
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Country [7]
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United States of America
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State/province [7]
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Oregon
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Country [8]
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United States of America
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State/province [8]
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Pennsylvania
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Country [9]
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United States of America
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State/province [9]
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Texas
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Country [10]
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Argentina
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State/province [10]
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Buenos Aires
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Argentina
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State/province [11]
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Córdoba
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Country [12]
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Austria
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Vienna
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Belgium
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Ghent
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Belgium
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Leuven
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Botswana
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Gaborone
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Brazil
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Ribeirão Preto
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Bulgaria
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Sofia
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Cameroon
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Yaoundé
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Canada
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Edmonton
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Canada
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Montréal
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Chile
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Santiago
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Colombia
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Manizales
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Denmark
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Copenhagen
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Ethiopia
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Addis Ababa
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France
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Bordeaux
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France
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Montpellier
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France
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State/province [27]
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Paris
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Country [28]
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Greece
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State/province [28]
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Thessaloníki
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India
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Kochi
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Italy
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Milan
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Japan
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State/province [31]
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Chiba
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Korea, Republic of
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Seoul
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Malaysia
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Kuala Lumpur
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Malta
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Imsida
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Netherlands
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Groningen
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Norway
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Oslo
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Pakistan
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Karachi
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Portugal
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Porto
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Senegal
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Thiès
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Sweden
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Gothenburg
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Sweden
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Lund
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Country [42]
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Sweden
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State/province [42]
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Stockholm
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Country [43]
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Sweden
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State/province [43]
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Umeå
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Sweden
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Uppsala
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Switzerland
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Bern
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Switzerland
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Genève
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Switzerland
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Lausanne
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Taiwan
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Taipei City
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Turkey
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Bornova
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United Kingdom
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London
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Country [51]
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United Kingdom
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State/province [51]
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Newcastle
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Funding & Sponsors
Primary sponsor type
Other
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Name
KU Leuven
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04902768
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Philip Moons, PhD, RN
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Address
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Professor in Healthcare Sciences
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04902768
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