Clinical trial NCT02150603: Patient-Reported Outcomes in Adults With Congenital Heart Disease
Official title: Assessment of Patterns of Patient-reported Outcomes in Adults With Congenital Heart Disease - International Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Defects, Congenital
Keywords: Heart defects, congenital
Patient-reported outcomes
Health status
Factors, psychosocial
Health behavior
Quality of life
Sense of coherence
Illness perceptions
Depression
Anxiety
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2014-05-30
Enrollment: 4000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: CROSS_SECTIONAL
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.

Brief 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).


Eligibility criteria: 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:

* Prior heart transplantation
* Isolated pulmonary hypertension
* Syndromes affecting cognitive abilities

Primary outcomes:
measure: Patient-reported health status (EuroQol-5D)
timeFrame: Baseline
measure: Patient-reported psychosocial functioning (Hospital Anxiety and Depression Scale)
timeFrame: Baseline
measure: Patient-reported behavioral outcomes (Health Behavior Scale - Congenital Heart Disease)
timeFrame: Baseline
measure: Patient-reported quality of life (Linear Analog Scale Quality of Life;Satisfaction with Life Scale)
timeFrame: Baseline
Secondary outcomes:
measure: Patient-reported sense of coherence (Sense of Coherence scale 13 items)
timeFrame: Baseline
measure: Patient-reported illness perceptions (Brief Illness Perception Questionnaire)
timeFrame: Baseline
measure: Patient-reported socio-demographic variables (e.g. age, educational level)
timeFrame: Baseline
measure: Medical variables by chart review (e.g. cardiac surgeries, frequency of follow-up)
timeFrame: Baseline
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford Hospital & Clinics
state: California
city: Saint Louis
country: United States
facility: Washington University and Barnes Jewish Heart & Vascular Center
state: Missouri
city: Omaha
country: United States
facility: Children's Hospital & Medical Center
state: Nebraska
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
city: Pittsburgh
country: United States
facility: Children's Hospital of Pittsburgh of UPMC
state: Pennsylvania
city: Córdoba
country: Argentina
facility: Hospital de Niños
city: Melbourne
country: Australia
facility: Private practice
city: Leuven
country: Belgium
facility: University Hospitals Leuven
city: Edmonton
country: Canada
facility: Northern Alberta Adult Congenital Heart Clinic
city: Montreal
country: Canada
facility: Montreal Heart Institute
city: Toronto
country: Canada
facility: Peter Munk Cardiac Center
city: Lyon
country: France
facility: Hôpital Luis Pradel
city: Chennai
country: India
facility: Frontier Lifeline Hospital
city: Milan
country: Italy
facility: IRCCS Policlinico San Donato Hospital
city: Chiba
country: Japan
facility: Chiba Cardiovascular Center
city: Msida
country: Malta
facility: Mater Dei Hospital
city: Amsterdam
country: Netherlands
facility: Amsterdam Medical Center
city: Oslo
country: Norway
facility: Oslo University Hospital
city: Gothenburg
country: Sweden
facility: Sahlgrenska University Hospital/ Östra
city: Stockholm
country: Sweden
facility: Karolinska Institute
city: Umeå
country: Sweden
facility: University Hospital of Umeå
city: Bern
country: Switzerland
facility: University Hospital Bern
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: KU Leuven
name: Philip Moons, PhD
role: STUDY_DIRECTOR
affiliation: KU Leuven
name: Koen Luyckx, PhD
role: STUDY_DIRECTOR
affiliation: Peter Munk Cardiac Centre, University Health Network
name: Adrienne Kovacs, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.