CompletedNCT02150603APPROACH-ISUpdated Mar 12, 2015

Patient-Reported Outcomes in Adults With Congenital Heart Disease

An observational study in Heart Defects, Congenital, sponsored by Philip Moons. Completed at 24 sites in 15 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-03-12.

Sponsored by Philip Moons · Observational

Study type: Observational
Time perspective: Cross-sectional
Enrollment: 4,000
Ages: 18 Years and older
Sex: All

Study summary

The purpose of this study is to examine the differences in perceived health, psychosocial functioning, behavioral outcomes and quality of life of adults with congenital heart disease who are living in different areas of the world, and how these differences can be understood (e.g., differences in sense of coherence or illness perceptions).

Conditions studied

Heart Defects, Congenital

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Keywords

Heart defects, congenital
Patient-reported outcomes
Health status
Factors, psychosocial
Health behavior
Quality of life
Sense of coherence
Illness perceptions
Depression
Anxiety

In context

Heart Defects, Congenital

991 studies on the registry are indexed under Heart Defects, Congenital; 251 are open to participants now.

This study's enrollment of 4,000 is above the median of 119 across 440 observational studies indexed under Heart Defects, Congenital.

Browse Heart Defects, Congenital studies →

Lead sponsor

This is the only study on the registry with Philip Moons as lead sponsor.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No
Sampling method: Non-probability sample

Study population

Adults with congenital heart disease who are in continuing follow-up at an adult congenital heart disease center or included in a national/regional registry.

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.

Inclusion criteria

Diagnosed with congenital heart disease, defined as: a gross structural abnormality of the heart or intra-thoracic great vessels that is actually or potentially of functional significance (including mild, moderate, and severe heart defects)
18 years of age or older
Diagnosed under the age of ten, i.e. before adolescence
Continuing follow-up at an adult congenital heart disease center or included in a national/regional registry
Physical, cognitive, and language abilities to complete self-report questionnaires

Exclusion criteria

Exclusion Criteria:

Prior heart transplantation
Isolated pulmonary hypertension
Syndromes affecting cognitive abilities

Study design

Time perspective: Cross-sectional
Enrollment: 4,000 participants (actual)
Patient registry: No

Groups and cohorts

Adults with congenital heart disease

What researchers measure

Primary outcomes

Patient-reported health status (EuroQol-5D)
Time frame: Baseline
Patient-reported psychosocial functioning (Hospital Anxiety and Depression Scale)
Time frame: Baseline
Patient-reported behavioral outcomes (Health Behavior Scale - Congenital Heart Disease)
Time frame: Baseline
Patient-reported quality of life (Linear Analog Scale Quality of Life;Satisfaction with Life Scale)
Time frame: Baseline

Secondary outcomes

Patient-reported sense of coherence (Sense of Coherence scale 13 items)
Time frame: Baseline
Patient-reported illness perceptions (Brief Illness Perception Questionnaire)
Time frame: Baseline
Patient-reported socio-demographic variables (e.g. age, educational level)
Time frame: Baseline
Medical variables by chart review (e.g. cardiac surgeries, frequency of follow-up)
Time frame: Baseline

Study locations

24 sites

Stanford Hospital & Clinics
Stanford, California, United States
Washington University and Barnes Jewish Heart & Vascular Center
Saint Louis, Missouri, United States
Children's Hospital & Medical Center
Omaha, Nebraska, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Nationwide Children's Hospital
Columbus, Ohio, United States
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, United States
Hospital de Niños
Córdoba, Argentina
Private practice
Melbourne, Australia
University Hospitals Leuven
Leuven, Belgium
Northern Alberta Adult Congenital Heart Clinic
Edmonton, Canada
Montreal Heart Institute
Montreal, Canada
Peter Munk Cardiac Center
Toronto, Canada
Hôpital Luis Pradel
Lyon, France
Frontier Lifeline Hospital
Chennai, India
IRCCS Policlinico San Donato Hospital
Milan, Italy
Chiba Cardiovascular Center
Chiba, Japan
Mater Dei Hospital
Msida, Malta
Amsterdam Medical Center
Amsterdam, Netherlands
Oslo University Hospital
Oslo, Norway
Sahlgrenska University Hospital/ Östra
Gothenburg, Sweden
Karolinska Institute
Stockholm, Sweden
University Hospital of Umeå
Umeå, Sweden
University Hospital Bern
Bern, Switzerland
National Taiwan University Hospital
Taipei, Taiwan

References and documents

Publications

Moons P, Luyckx K, Thomet C, Budts W, Enomoto J, Sluman MA, Yang HL, Jackson JL, Khairy P, Cook SC, Chidambarathanu S, Alday L, Oechslin E, Eriksen K, Dellborg M, Berghammer M, Johansson B, Mackie AS, Menahem S, Caruana M, Veldtman G, Soufi A, Fernandes SM, White K, Callus E, Kutty S, Kovacs AH; APPROACH-IS consortium. Patient-reported outcomes in the aging population of adults with congenital heart disease: results from APPROACH-IS. Eur J Cardiovasc Nurs. 2023 May 25;22(4):339-344. doi: 10.1093/eurjcn/zvac057. PubMed 35901014 ↗
Lu CW, Wang JK, Yang HL, Kovacs AH, Luyckx K, Ruperti-Repilado FJ, Van De Bruaene A, Enomoto J, Sluman MA, Jackson JL, Khairy P, Cook SC, Chidambarathanu S, Alday L, Oechslin E, Eriksen K, Dellborg M, Berghammer M, Johansson B, Mackie AS, Menahem S, Caruana M, Veldtman G, Soufi A, Fernandes SM, White K, Callus E, Kutty S, Apers S, Moons P; APPROACH-IS consortium, the International Society for Adult Congenital Heart Disease (ISACHD) *. Heart Failure and Patient-Reported Outcomes in Adults With Congenital Heart Disease from 15 Countries. J Am Heart Assoc. 2022 May 3;11(9):e024993. doi: 10.1161/JAHA.121.024993. Epub 2022 Apr 26. PubMed 35470715 ↗
Fox KR, Hardy RY, Moons P, Kovacs AH, Luyckx K, Apers S, Cook SC, Veldtman G, Fernandes SM, White K, Kutty S, Jackson JL; APPROACH-IS Consortium and the International Society for Adult Congenital Heart Disease (ISACHD). Smoking among adult congenital heart disease survivors in the United States: Prevalence and relationship with illness perceptions. J Behav Med. 2021 Dec;44(6):772-783. doi: 10.1007/s10865-021-00239-5. Epub 2021 Jun 29. PubMed 34185220 ↗
Moons P, Luyckx K, Thomet C, Budts W, Enomoto J, Sluman MA, Lu CW, Jackson JL, Khairy P, Cook SC, Chidambarathanu S, Alday L, Eriksen K, Dellborg M, Berghammer M, Johansson B, Mackie AS, Menahem S, Caruana M, Veldtman G, Soufi A, Fernandes SM, White K, Callus E, Kutty S, Ombelet F, Apers S, Kovacs AH; APPROACH-IS Consortium and the International Society for Adult Congenital Heart Disease (ISACHD). Physical Functioning, Mental Health, and Quality of Life in Different Congenital Heart Defects: Comparative Analysis in 3538 Patients From 15 Countries. Can J Cardiol. 2021 Feb;37(2):215-223. doi: 10.1016/j.cjca.2020.03.044. Epub 2020 Apr 6. PubMed 32739453 ↗
Moons P, Apers S, Kovacs AH, Thomet C, Budts W, Enomoto J, Sluman MA, Wang JK, Jackson JL, Khairy P, Cook SC, Chidambarathanu S, Alday L, Oechslin E, Eriksen K, Dellborg M, Berghammer M, Johansson B, Mackie AS, Menahem S, Caruana M, Veldtman G, Soufi A, Fernandes SM, White K, Callus E, Kutty S, Luyckx K; APPROACH-IS consortium and the International Society for Adult Congenital Heart Disease (ISACHD). Sense of coherence in adults with congenital heart disease in 15 countries: Patient characteristics, cultural dimensions and quality of life. Eur J Cardiovasc Nurs. 2021 Feb 11;20(1):48-55. doi: 10.1177/1474515120930496. PubMed 32524857 ↗
Van Bulck L, Goossens E, Luyckx K, Apers S, Oechslin E, Thomet C, Budts W, Enomoto J, Sluman MA, Lu CW, Jackson JL, Khairy P, Cook SC, Chidambarathanu S, Alday L, Eriksen K, Dellborg M, Berghammer M, Johansson B, Mackie AS, Menahem S, Caruana M, Veldtman G, Soufi A, Fernandes SM, White K, Callus E, Kutty S, Moons P; APPROACH-IS consortium and the International Society for Adult Congenital Heart Disease (ISACHD). Healthcare system inputs and patient-reported outcomes: a study in adults with congenital heart defect from 15 countries. BMC Health Serv Res. 2020 Jun 3;20(1):496. doi: 10.1186/s12913-020-05361-9. PubMed 32493367 ↗
Holbein CE, Veldtman GR, Moons P, Kovacs AH, Luyckx K, Apers S, Chidambarathanu S, Soufi A, Eriksen K, Jackson JL, Enomoto J, Fernandes SM, Johansson B, Alday L, Dellborg M, Berghammer M, Menahem S, Caruana M, Kutty S, Mackie AS, Thomet C, Budts W, White K, Sluman MA, Callus E, Cook SC, Khairy P, Cedars A; APPROACH-IS consortium and the International Society for Adult Congenital Heart Disease (ISACHD). Perceived Health Mediates Effects of Physical Activity on Quality of Life in Patients With a Fontan Circulation. Am J Cardiol. 2019 Jul 1;124(1):144-150. doi: 10.1016/j.amjcard.2019.03.039. Epub 2019 Apr 10. PubMed 31030969 ↗
Apers S, Kovacs AH, Luyckx K, Alday L, Berghammer M, Budts W, Callus E, Caruana M, Chidambarathanu S, Cook SC, Dellborg M, Enomoto J, Eriksen K, Fernandes SM, Jackson JL, Johansson B, Khairy P, Kutty S, Menahem S, Rempel G, Sluman MA, Soufi A, Thomet C, Veldtman G, Wang JK, White K, Moons P; APPROACH-IS consortium; International Society for Adult Congenital Heart Disease (ISACHD). Assessment of Patterns of Patient-Reported Outcomes in Adults with Congenital Heart disease - International Study (APPROACH-IS): rationale, design, and methods. Int J Cardiol. 2015 Jan 20;179:334-42. doi: 10.1016/j.ijcard.2014.11.084. Epub 2014 Nov 8. PubMed 25464481 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Mar 12, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02150603
Lead sponsor: Philip Moons
Responsible party: Philip Moons (prof. dr. Philip Moons, Universitaire Ziekenhuizen KU Leuven) — Sponsor-investigator
First posted: May 30, 2014
Start date: Apr 2013
Primary completion: Feb 2015
Completion: Feb 2015
Last update: Mar 12, 2015

Study contacts

Philip Moons, PhD

study director · KU Leuven

Koen Luyckx, PhD

study director · KU Leuven

Adrienne Kovacs, PhD

study director · Peter Munk Cardiac Centre, University Health Network

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.

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