Assessment of Patterns of Patient Reported Outcomes in Adults With Congenital Heart Disease - International Study II
NCT ID: NCT04902768
Last Updated: 2024-05-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
8415 participants
OBSERVATIONAL
2019-08-01
2022-12-31
Brief Summary
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Detailed Description
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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").
Conditions
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Study Design
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CASE_ONLY
CROSS_SECTIONAL
Study Groups
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Adults with congenital heart disease
This is an observational study, there is no intervention
This is an observational study, there is no intervention. Hence, this is not applicable.
Interventions
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This is an observational study, there is no intervention
This is an observational study, there is no intervention. Hence, this is not applicable.
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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KU Leuven
OTHER
Responsible Party
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Philip Moons
Prof. Dr. Philip Moons
Principal Investigators
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Philip Moons, PhD, RN
Role: PRINCIPAL_INVESTIGATOR
Professor in Healthcare Sciences
Locations
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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
Hospital San Juan De Dios De La Plata
Buenos Aires, , Argentina
Hospital de Niños
Córdoba, , Argentina
Melbourne Children's Cardiology
Melbourne, , Australia
Vienna General Hospital
Vienna, , Austria
Ghent University Hospital
Ghent, , Belgium
University Hospitals Leuven
Leuven, , Belgium
Princess Marina Hospital
Gaborone, , Botswana
Hospital das Clinicas da Faculdade de Medicina de Ribeirão Preto
Ribeirão Preto, , Brazil
National Heart Hospital
Sofia, , Bulgaria
Clinique Medical Le Jourdain
Yaoundé, , Cameroon
Mazankowski Alberta Heart Institute
Edmonton, , Canada
Montreal Heart Institute, Université de Montréal
Montreal, , Canada
Intituto Nacional Del Torax
Santiago, , Chile
Meintegral Clinic
Manizales, , Colombia
Copenhagen University Hospital
Copenhagen, , Denmark
College of Health sciences, Addis Ababa University
Addis Ababa, , Ethiopia
Hôpital cardiologique Haut-Leveque
Bordeaux, , France
Montpellier University Hospital
Montpellier, , France
Hôpital Européen Georges Pompidou
Paris, , France
AHEPA University Hospital
Thessaloniki, , Greece
Amrita Institute of Medical Sciences
Kochi, , India
Policlinico San Donato (IRCCS)
Milan, , Italy
Chiba Cerebral and Cardiovascular Center
Chiba, , Japan
Paediatric & Congenital Heart Centre, IJN (National Heart Institute)
Kuala Lumpur, , Malaysia
Mater Dei Hospital
Msida, , Malta
Centrum voor Congenital Hartafwijkingen
Groningen, , Netherlands
Oslo University Hospital, Rikshospitalet
Oslo, , Norway
Aga Khan University Hospital
Karachi, , Pakistan
Reference Center of Congenital Heart Disease , University Hospital Center of São João
Porto, , Portugal
Centre Hospitalier Régional de Thiès
Thiès, , Senegal
Samsung Medical Center
Seoul, , South Korea
Sahlgrenska University Hospital
Gothenburg, , Sweden
Skånes Universitetssjukhus
Lund, , Sweden
Karolinska Universitetssjukhuset
Stockholm, , Sweden
Umea University Hospital
Umeå, , Sweden
Uppsala University Hospital
Uppsala, , Sweden
University Hospital Bern
Bern, , Switzerland
Hôpitaux Universitaires de Genève
Geneva, , Switzerland
Centre Hospitalier universitaire vaudois
Lausanne, , Switzerland
National Taiwan University Hospital
Taipei, , Taiwan
Ege University Health Application and Research Center, Cardiology Department
Bornova, , Turkey (Türkiye)
Royal Brompton Hospital, Royal Brompton & Harefield Hospitals, Guy's and St Thomas' NHS Foundation Trust
London, , United Kingdom
Freeman Hospital, Newcastle Upon Tyne Hospitals NHS Foundation Trust
Newcastle, , United Kingdom
Countries
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References
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Ansari Ramandi MM, Van Bulck L, Ceelen DCH, Voors AA, Goossens E, Kovacs AH, Luyckx K, Van De Bruaene A, Gabriel H, Lykkeberg B, Thomet C, de Hosson M, Ladouceur M, Saidi A, Kosmidis D, Areias ME, Miranda J, Sandberg C, Mandalenakis Z, Coats L, Amedro P, Khairy P, Valente AM, Johansson B, Kaneva A, Andresen B, Christersson C, Reyes FB, Hlebowicz J, Enomoto J, Kim YY, Menahem S, Yang HL, Moon JR, Bredy C, Schmidt A, Callus E, Araujo JJ, Constantine A, Zaidi A, Bouchardy J, Jameson SM, Kutty S, McGrath LB, Leong MC, Ortiz L, Korkmaz FD, Caruana M, Leye M, Moons P, van Melle JP; APPROACH-IS II Consortium; International Society for Adults With Congenital Heart Disease. Quality of Life in Adults With Transposition of the Great Arteries With a Systemic Right or Left Ventricle. Can J Cardiol. 2025 Sep 15:S0828-282X(25)01161-4. doi: 10.1016/j.cjca.2025.09.010. Online ahead of print.
Moons P, Kovacs AH, Goossens E, Luyckx K, Ladak L, Leye M, Van De Bruaene A, Leong MC, Kaneva A, Manso PH, Araujo JJ, Sasikumar N, Gabriel H, Yadeta D, Wang JK, Enomoto J, Areias ME, Kosmidis D, Coats L, Valente AM, Moon JR, Ladouceur M, Thomet C, Jackson JL, Sandberg C, Callus E, Kim YY, Lykkeberg B, Alday L, Bredy C, Saidi A, Baraona Reyes F, Menahem S, de Hosson M, Hlebowicz J, Christersson C, Zaidi AN, Johansson B, Andresen B, Ambassa JC, Mattsson E, Constantine A, Amedro P, van Melle JP, Kutty S, Ortiz L, Demir F, Khairy P, Windram J, Bouchardy J, Caruana M, Jameson SM, Mahadevan VS, McGrath LB, Mwita JC, Van Bulck L; APPROACH-IS II consortium, on behalf of the International Society for Adults Congenital Heart Disease (ISACHD). Perceived health, psychological distress and quality of life in 8415 adults with congenital heart disease from 32 countries. Heart. 2025 Aug 12;111(17):818-827. doi: 10.1136/heartjnl-2024-325296.
Moons P, Goossens E, Luyckx K, Kovacs AH, Andresen B, Moon JR, Van De Bruaene A, Rassart J, Van Bulck L; APPROACH-IS II consortium and ISACHD. The COVID-19 pandemic as experienced by adults with congenital heart disease from Belgium, Norway, and South Korea: impact on life domains, patient-reported outcomes, and experiences with care. Eur J Cardiovasc Nurs. 2022 Aug 29;21(6):620-629. doi: 10.1093/eurjcn/zvab120.
Other Identifiers
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S62537
Identifier Type: -
Identifier Source: org_study_id
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