Ignite Creation Date:
2025-12-24 @ 7:19 PM
Ignite Modification Date:
2026-01-02 @ 2:17 PM
Study NCT ID:
NCT02150603
Status:
COMPLETED
Last Update Posted:
2015-03-12
First Post:
2014-05-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Patient-Reported Outcomes in Adults With Congenital Heart Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United Kingdom']}, 'conditionBrowseModule': {'meshes': [{'id': 'D006330', 'term': 'Heart Defects, Congenital'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D003863', 'term': 'Depression'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-11', 'studyFirstSubmitDate': '2014-05-21', 'studyFirstSubmitQcDate': '2014-05-27', 'lastUpdatePostDateStruct': {'date': '2015-03-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-05-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'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'}], 'secondaryOutcomes': [{'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'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Heart defects, congenital', 'Patient-reported outcomes', 'Health status', 'Factors, psychosocial', 'Health behavior', 'Quality of life', 'Sense of coherence', 'Illness perceptions', 'Depression', 'Anxiety'], 'conditions': ['Heart Defects, Congenital']}, 'referencesModule': {'references': [{'pmid': '38233017', 'type': 'DERIVED', 'citation': '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': '35901014', 'type': 'DERIVED', '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.'}, {'pmid': '35470715', 'type': 'DERIVED', '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.'}, {'pmid': '34185220', 'type': 'DERIVED', '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.'}, {'pmid': '32739453', 'type': 'DERIVED', '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.'}, {'pmid': '32524857', 'type': 'DERIVED', '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.'}, {'pmid': '32493367', 'type': 'DERIVED', '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.'}, {'pmid': '31030969', 'type': 'DERIVED', '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.'}, {'pmid': '25464481', 'type': 'DERIVED', '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.'}], 'seeAlsoLinks': [{'url': 'http://approach-is.net/', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': '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).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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)\n* 18 years of age or older\n* Diagnosed under the age of ten, i.e. before adolescence\n* Continuing follow-up at an adult congenital heart disease center or included in a national/regional registry\n* Physical, cognitive, and language abilities to complete self-report questionnaires\n\nExclusion Criteria:\n\n* Prior heart transplantation\n* Isolated pulmonary hypertension\n* Syndromes affecting cognitive abilities'}, 'identificationModule': {'nctId': 'NCT02150603', 'acronym': 'APPROACH-IS', 'briefTitle': 'Patient-Reported Outcomes in Adults With Congenital Heart Disease', 'organization': {'class': 'OTHER', 'fullName': 'Universitaire Ziekenhuizen KU Leuven'}, 'officialTitle': 'Assessment of Patterns of Patient-reported Outcomes in Adults With Congenital Heart Disease - International Study', 'orgStudyIdInfo': {'id': 'ML9231'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Adults with congenital heart disease'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford Hospital & Clinics', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}, {'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University and Barnes Jewish Heart & Vascular Center', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': "Children's Hospital & Medical Center", 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': "Cincinnati Children's Hospital Medical Center", 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': "Nationwide Children's Hospital", 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': "Children's Hospital of Pittsburgh of UPMC", 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'city': 'Córdoba', 'country': 'Argentina', 'facility': 'Hospital de Niños', 'geoPoint': {'lat': -31.40648, 'lon': -64.18853}}, {'city': 'Melbourne', 'country': 'Australia', 'facility': 'Private practice', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}, {'city': 'Leuven', 'country': 'Belgium', 'facility': 'University Hospitals Leuven', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'city': 'Edmonton', 'country': 'Canada', 'facility': 'Northern Alberta Adult Congenital Heart Clinic', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'city': 'Montreal', 'country': 'Canada', 'facility': 'Montreal Heart Institute', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'city': 'Toronto', 'country': 'Canada', 'facility': 'Peter Munk Cardiac Center', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'city': 'Lyon', 'country': 'France', 'facility': 'Hôpital Luis Pradel', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'city': 'Chennai', 'country': 'India', 'facility': 'Frontier Lifeline Hospital', 'geoPoint': {'lat': 13.08784, 'lon': 80.27847}}, {'city': 'Milan', 'country': 'Italy', 'facility': 'IRCCS Policlinico San Donato Hospital', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'city': 'Chiba', 'country': 'Japan', 'facility': 'Chiba Cardiovascular Center', 'geoPoint': {'lat': 35.6, 'lon': 140.11667}}, {'city': 'Msida', 'country': 'Malta', 'facility': 'Mater Dei Hospital', 'geoPoint': {'lat': 35.8925, 'lon': 14.48278}}, {'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'Amsterdam Medical Center', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'city': 'Oslo', 'country': 'Norway', 'facility': 'Oslo University Hospital', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}, {'city': 'Gothenburg', 'country': 'Sweden', 'facility': 'Sahlgrenska University Hospital/ Östra', 'geoPoint': {'lat': 57.70716, 'lon': 11.96679}}, {'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Karolinska Institute', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}, {'city': 'Umeå', 'country': 'Sweden', 'facility': 'University Hospital of Umeå', 'geoPoint': {'lat': 63.82842, 'lon': 20.25972}}, {'city': 'Bern', 'country': 'Switzerland', 'facility': 'University Hospital Bern', 'geoPoint': {'lat': 46.94809, 'lon': 7.44744}}, {'city': 'Taipei', 'country': 'Taiwan', 'facility': 'National Taiwan University Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'overallOfficials': [{'name': 'Philip Moons, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'KU Leuven'}, {'name': 'Koen Luyckx, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'KU Leuven'}, {'name': 'Adrienne Kovacs, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Peter Munk Cardiac Centre, University Health Network'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Philip Moons', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'prof. dr. Philip Moons', 'investigatorFullName': 'Philip Moons', 'investigatorAffiliation': 'Universitaire Ziekenhuizen KU Leuven'}}}}