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APPROACH-IS II
APPROACH-IS II: Assessment of Patterns of Patient Reported Outcomes in Adults With Congenital Heart Disease - International Study II
Sponsor study identifier
observational
8,415
32 countries
53
Study Start
August 1, 2019
Actual (reported)Primary Completion
August 31, 2022
Actual (reported)Study Completion
December 31, 2022
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2022
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 1, 2019
Actual (reported)May 20, 2021
Actual (reported)May 26, 2021
Actual (reported)August 31, 2022
Actual (reported)December 31, 2022
Actual (reported)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).
Patient-reported stigma
Baseline
Patient-reported illness identity
Baseline
Patient-reported empowerment
Baseline
Patient-reported healthcare utilization
Baseline
Patient-reported functional status
Baseline
This is an observational study, there is no intervention. Hence, this is not applicable.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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.
University of California
San Francisco, California, 92093-0021, United States
Lucile Packard Children's Hospital and Stanford Health Care
Stanford, California, 94304, United States
University of Florida Health
Gainesville, Florida, 32611, United States
Taussig Heart Center of Johns Hopkins Hospital
Baltimore, Maryland, 21287, United States
Boston Children's / Brigham and Women's
Boston, Massachusetts, 02115, United States
Mount Sinai Heart
New York, New York, 10029, United States
Nationwide Children's Hospital
Van Bulck L, Goossens E, Kovacs AH, Luyckx K, Ladak LA, Leye M, Van De Bruaene A, Leong MC, Kaneva A, Pavao RB, Araujo JJ, Sasikumar N, Gabriel H, Goshu DY, Lu CW, 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, Reyes FB, Menahem S, de Hosson M, Mandelenakis Z, Christersson C, Zaidi A, Johansson B, Andresen B, Ambassa JC, Mattsson E, Constantine A, Amedro P, van Melle JP, Cedars A, Ortiz L, Demir F, Khairy P, Windram J, Bouchardy J, Caruana M, Jameson SM, Mahadevan VS, McGrath LB, Mwita JC, Moons P; APPROACH-IS II consortium, International Society for Adults Congenital Heart Disease (ISACHD). Advance Care Planning in Adults With Congenital Heart Diseases: Current Practices, Preferences, and Needs of 8,281 Adults From 32 Countries. Can J Cardiol. 2026 Jun;42(6):1338-1348. doi: 10.1016/j.cjca.2025.12.039. Epub 2026 Jan 8.
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, Baraona Reyes F, 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, Demir Korkmaz F, 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 Dec;41(12):2544-2553. doi: 10.1016/j.cjca.2025.09.010. Epub 2025 Sep 15.
Philip Moons, PhD, RN
Professor in Healthcare Sciences
8,415 participants (actual enrollment reported by the registry).
First Submitted
May 20, 2021
First Posted
May 26, 2021
Study Start
August 1, 2019
Actual (reported)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
Contact the study team to confirm eligibility.
Columbus, Ohio, 43205, United States
Oregon Health and Science University
Portland, Oregon, 97239, United States
Philadelphia Penn Medicine
Philadelphia, Pennsylvania, 19104, United States
University of Southwestern Medical Center
Dallas, Texas, 75390, 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
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.
Primary Completion
August 31, 2022
Actual (reported)Study Completion
December 31, 2022
Actual (reported)Last Updated
May 16, 2024
Record last verified: 2024-05
Well-argued and reasonable requests can be directed to the Principal Investigator (Prof. Philip Moons) of the study.
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Source: ClinicalTrials.gov.
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