Assessment of Patterns of Patient Reported Outcomes in Adults With Congenital Heart Disease - International Study II

NCT04902768 | Completed

• 1 other identifier: S62537
• Study Type: observational
• Target: 8,415
• Locations: 29 countries
• Sites: 50

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.

Conditions

Congenital Heart Disease

Keywords

Congenital Heart Disease; Quality of life; Patient reported outcomes; Patient reported experience measures; Geriatric phenotype

Outcome Measures

Primary Outcomes (8)

• 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).

  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

Secondary Outcomes (12)

• Patient-reported stigma

  Baseline

• Patient-reported illness identity

  Baseline

• Patient-reported empowerment

  Baseline

• Patient-reported healthcare utilization

  Baseline

• Patient-reported functional status

  Baseline

Study Arms (1)

Adults with congenital heart disease

Other: This is an observational study, there is no intervention

Interventions

This is an observational study, there is no intervention OTHER

This is an observational study, there is no intervention. Hence, this is not applicable.

Adults with congenital heart disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

• 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)"
• 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

You may not qualify if:

• \- Prior heart transplantation

Sponsors & Collaborators

• KU Leuven: lead

Study Sites (53)

University of California

San Francisco, California, 92093-0021, United States

Location

Lucile Packard Children's Hospital and Stanford Health Care

Stanford, California, 94304, United States

Location

University of Florida Health

Gainesville, Florida, 32611, United States

Location

Taussig Heart Center of Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Boston Children's / Brigham and Women's

Boston, Massachusetts, 02115, United States

Location

Mount Sinai Heart

New York, New York, 10029, United States

Location

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

Philadelphia Penn Medicine

Philadelphia, Pennsylvania, 19104, United States

Location

University of Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Hospital San Juan De Dios De La Plata

Buenos Aires, Argentina

Location

Hospital de Niños

Córdoba, Argentina

Location

Melbourne Children's Cardiology

Melbourne, Australia

Location

Vienna General Hospital

Vienna, Austria

Location

Ghent University Hospital

Ghent, Belgium

Location

University Hospitals Leuven

Leuven, Belgium

Location

Princess Marina Hospital

Gaborone, Botswana

Location

Hospital das Clinicas da Faculdade de Medicina de Ribeirão Preto

Ribeirão Preto, Brazil

Location

National Heart Hospital

Sofia, Bulgaria

Location

Clinique Medical Le Jourdain

Yaoundé, Cameroon

Location

Mazankowski Alberta Heart Institute

Edmonton, Canada

Location

Montreal Heart Institute, Université de Montréal

Montreal, Canada

Location

Intituto Nacional Del Torax

Santiago, Chile

Location

Meintegral Clinic

Manizales, Colombia

Location

Copenhagen University Hospital

Copenhagen, Denmark

Location

College of Health sciences, Addis Ababa University

Addis Ababa, Ethiopia

Location

Hôpital cardiologique Haut-Leveque

Bordeaux, France

Location

Montpellier University Hospital

Montpellier, France

Location

Hôpital Européen Georges Pompidou

Paris, France

Location

AHEPA University Hospital

Thessaloniki, Greece

Location

Amrita Institute of Medical Sciences

Kochi, India

Location

Policlinico San Donato (IRCCS)

Milan, Italy

Location

Chiba Cerebral and Cardiovascular Center

Chiba, Japan

Location

Paediatric & Congenital Heart Centre, IJN (National Heart Institute)

Kuala Lumpur, Malaysia

Location

Mater Dei Hospital

Msida, Malta

Location

Centrum voor Congenital Hartafwijkingen

Groningen, Netherlands

Location

Oslo University Hospital, Rikshospitalet

Oslo, Norway

Location

Aga Khan University Hospital

Karachi, Pakistan

Location

Reference Center of Congenital Heart Disease , University Hospital Center of São João

Porto, Portugal

Location

Centre Hospitalier Régional de Thiès

Thiès, Senegal

Location

Samsung Medical Center

Seoul, South Korea

Location

Sahlgrenska University Hospital

Gothenburg, Sweden

Location

Skånes Universitetssjukhus

Lund, Sweden

Location

Karolinska Universitetssjukhuset

Stockholm, Sweden

Location

Umea University Hospital

Umeå, Sweden

Location

Uppsala University Hospital

Uppsala, Sweden

Location

University Hospital Bern

Bern, Switzerland

Location

Hôpitaux Universitaires de Genève

Geneva, Switzerland

Location

Centre Hospitalier universitaire vaudois

Lausanne, Switzerland

Location

National Taiwan University Hospital

Taipei, Taiwan

Location

Ege University Health Application and Research Center, Cardiology Department

Bornova, Turkey (Türkiye)

Location

Royal Brompton Hospital, Royal Brompton & Harefield Hospitals, Guy's and St Thomas' NHS Foundation Trust

London, United Kingdom

Location

Freeman Hospital, Newcastle Upon Tyne Hospitals NHS Foundation Trust

Newcastle, United Kingdom

Location

Related Publications (3)

• 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.

  PMID: 40962221 DERIVED

• 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.

  PMID: 40579213 DERIVED

• 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.

  PMID: 34927192 DERIVED

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Philip Moons, PhD, RN

  Professor in Healthcare Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. Philip Moons

Study Record Dates

• First Submitted: May 20, 2021
• First Posted: May 26, 2021
• Study Start: August 1, 2019
• Primary Completion: August 31, 2022
• Study Completion: December 31, 2022
• Last Updated: May 16, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

AR (2); IN (1); BR (1); SE (5); NL (1); JP (1); NO (1); PA (1); AU (1); CO (1); GR (1); GB (2); US (10); DK (1); IT (1); TW (1); PT (1); BO (1); BE (2); MA (1); ET (1); FR (3); CH (3); TU (1); BU (1); MY (1); CA (2); KR (1); CL (1)