NCT02150603

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).

Trial Health

98
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2013

Geographic Reach
15 countries

24 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

May 21, 2014

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 30, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

March 12, 2015

Status Verified

March 1, 2015

Enrollment Period

1.8 years

First QC Date

May 21, 2014

Last Update Submit

March 11, 2015

Conditions

Heart Defects, Congenital

Keywords

Heart defects, congenitalPatient-reported outcomesHealth statusFactors, psychosocialHealth behaviorQuality of lifeSense of coherenceIllness perceptionsDepressionAnxiety

Outcome Measures

Primary Outcomes (4)

  • Patient-reported health status (EuroQol-5D)

    Baseline

  • Patient-reported psychosocial functioning (Hospital Anxiety and Depression Scale)

    Baseline

  • Patient-reported behavioral outcomes (Health Behavior Scale - Congenital Heart Disease)

    Baseline

  • Patient-reported quality of life (Linear Analog Scale Quality of Life;Satisfaction with Life Scale)

    Baseline

Secondary Outcomes (4)

  • Patient-reported sense of coherence (Sense of Coherence scale 13 items)

    Baseline

  • Patient-reported illness perceptions (Brief Illness Perception Questionnaire)

    Baseline

  • Patient-reported socio-demographic variables (e.g. age, educational level)

    Baseline

  • Medical variables by chart review (e.g. cardiac surgeries, frequency of follow-up)

    Baseline

Study Arms (1)

Adults with congenital heart disease

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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)
  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (24)

Stanford Hospital & Clinics

Stanford, California, United States

Location

Washington University and Barnes Jewish Heart & Vascular Center

St Louis, Missouri, United States

Location

Children's Hospital & Medical Center

Omaha, Nebraska, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Location

Nationwide Children's Hospital

Columbus, Ohio, United States

Location

Children's Hospital of Pittsburgh of UPMC

Pittsburgh, Pennsylvania, United States

Location

Hospital de Niños

Córdoba, Argentina

Location

Private practice

Melbourne, Australia

Location

University Hospitals Leuven

Leuven, Belgium

Location

Northern Alberta Adult Congenital Heart Clinic

Edmonton, Canada

Location

Montreal Heart Institute

Montreal, Canada

Location

Peter Munk Cardiac Center

Toronto, Canada

Location

Hôpital Luis Pradel

Lyon, France

Location

Frontier Lifeline Hospital

Chennai, India

Location

IRCCS Policlinico San Donato Hospital

Milan, Italy

Location

Chiba Cardiovascular Center

Chiba, Japan

Location

Mater Dei Hospital

Msida, Malta

Location

Amsterdam Medical Center

Amsterdam, Netherlands

Location

Oslo University Hospital

Oslo, Norway

Location

Sahlgrenska University Hospital/ Östra

Gothenburg, Sweden

Location

Karolinska Institute

Stockholm, Sweden

Location

University Hospital of Umeå

Umeå, Sweden

Location

University Hospital Bern

Bern, Switzerland

Location

National Taiwan University Hospital

Taipei, Taiwan

Location

Related Publications (9)

  • Kovacs AH, Luyckx K, Thomet C, Budts W, Enomoto J, Sluman MA, Lu CW, Jackson JL, Khairy P, Cook SC, Chidambarathanu S, Alday L, Estensen ME, Dellborg M, Berghammer M, Johansson B, Mackie AS, Menahem S, Caruana M, Veldtman G, Soufi A, Jameson SM, Callus E, Kutty S, Oechslin E, Van Bulck L, Moons P; APPROACH-IS Consortium, International Society for Adult Congenital Heart Disease. Anxiety and Depression in Adults With Congenital Heart Disease. J Am Coll Cardiol. 2024 Jan 23;83(3):430-441. doi: 10.1016/j.jacc.2023.10.043.

    PMID: 38233017DERIVED

  • 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.

    PMID: 35901014DERIVED

  • 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.

    PMID: 35470715DERIVED

  • 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.

    PMID: 34185220DERIVED

  • 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.

    PMID: 32739453DERIVED

  • 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.

    PMID: 32524857DERIVED

  • 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.

    PMID: 32493367DERIVED

  • 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.

    PMID: 31030969DERIVED

  • 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.

    PMID: 25464481DERIVED

Related Links

MeSH Terms

Conditions

Heart Defects, CongenitalHealth BehaviorDepressionAnxiety Disorders

Condition Hierarchy (Ancestors)

Cardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesBehaviorBehavioral SymptomsMental Disorders

Study Officials

  • Philip Moons, PhD

    KU Leuven

    STUDY DIRECTOR

  • Koen Luyckx, PhD

    KU Leuven

    STUDY DIRECTOR

  • Adrienne Kovacs, PhD

    Peter Munk Cardiac Centre, University Health Network

    STUDY DIRECTOR

Study Design

Study Type
observational
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
prof. dr. Philip Moons

Study Record Dates

First Submitted

May 21, 2014

First Posted

May 30, 2014

Study Start

April 1, 2013

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

March 12, 2015

Record last verified: 2015-03

Locations

TW(1)MA(1)NL(1)FR(1)AU(1)IN(1)SE(3)US(6)AR(1)CH(1)BE(1)IT(1)CA(3)NO(1)JP(1)