Ignite Creation Date:
2025-12-24 @ 5:30 PM
Ignite Modification Date:
2026-02-22 @ 4:52 PM
Study NCT ID:
NCT04902768
Status:
COMPLETED
Last Update Posted:
2024-05-16
First Post:
2021-05-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of Patterns of Patient Reported Outcomes in Adults With Congenital Heart Disease - International Study II
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Nigeria', 'Saudi Arabia']}, 'conditionBrowseModule': {'meshes': [{'id': 'D006330', 'term': 'Heart Defects, Congenital'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8415}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-15', 'studyFirstSubmitDate': '2021-05-20', 'studyFirstSubmitQcDate': '2021-05-25', 'lastUpdatePostDateStruct': {'date': '2024-05-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient-reported health status', 'timeFrame': 'Baseline', 'description': '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).'}, {'measure': 'Patient-reported health status', 'timeFrame': 'Baseline', 'description': '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).'}, {'measure': 'Patient-reported depressive symptoms', 'timeFrame': 'Baseline', 'description': 'This outcomes is measured using the Patient Health Questionnaire 8. Scores range from 0 to 24. Scores of ≥10 indicate depression.'}, {'measure': 'Patient-reported anxiety symptoms', 'timeFrame': 'Baseline', 'description': '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.'}, {'measure': 'Patient-reported quality of life', 'timeFrame': 'Baseline', 'description': '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).'}, {'measure': "Patients' perception of providers' autonomy support", 'timeFrame': 'Baseline', 'description': '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.'}, {'measure': 'Cognitive functioning', 'timeFrame': 'Baseline', 'description': 'This outcome is measured using the Montreal Cognitive Assessment Screener (MoCA). Scores range from 0 to 30. Scores of \\<26 indicate cognitive dysfunction.'}, {'measure': 'Frailty phenotype', 'timeFrame': 'Baseline', 'description': '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).'}], 'secondaryOutcomes': [{'measure': 'Patient-reported stigma', 'timeFrame': 'Baseline', 'description': 'This outcome is measured using the Chronic Illness Stigma Scale (CISS). Scores range from 8 to 40. Higher scores indicating higher levels of perceived stigma.'}, {'measure': 'Patient-reported illness identity', 'timeFrame': 'Baseline', 'description': 'This outcome is measured using the Illness Identity Questionnaire (IIQ). The questionnaire consists of a five-item rejection scale, seven-item enrichment scale, five-item acceptance scale and eight-item engulfment scale. A mean score is calculated per subscale. Higher scores indicate more rejection, enrichment, acceptance or engulfment.'}, {'measure': 'Patient-reported empowerment', 'timeFrame': 'Baseline', 'description': 'This outcome is measured using the Gothenburg Empowerment Scale (GES generic v1.1). Scores range from 15 to 75. Higher score reflects a higher level of empowerment.'}, {'measure': 'Patient-reported healthcare utilization', 'timeFrame': 'Baseline', 'description': 'This outcomes was measured using the Patient-Reported Inpatient and outpatient Utilization Survey (PRIUS). Higher numbers indicate more healthcare use.'}, {'measure': 'Patient-reported functional status', 'timeFrame': 'Baseline', 'description': 'This outcome is classified according to the New York Heart Association (NYHA).'}, {'measure': 'Patient-reported social support', 'timeFrame': 'Baseline', 'description': 'This outcomes is measured using the Multidimensional Scale on Perceived Social Support Scale (MSPSS). Scores range from 12 to 84. Higher score indicates greater social support perceived by an individual.'}, {'measure': 'Patient-reported parental involvement', 'timeFrame': 'Baseline', 'description': 'This outcome is measured using an adapted version of the subscale on parents of the Multidimensional Scale on Perceived Social Support. Scores range from 5 to 35. Higher score indicates greater parental support in childhood and adolescence.'}, {'measure': 'Advance care planning', 'timeFrame': 'Baseline', 'description': "This outcome is measured using a survey developed for APPROACH-IS II by the Steering Committee, based on previous research. A sample question is 'Have you personally written down information about the care you would want in case you become seriously ill in the future?'."}, {'measure': 'Patient-reported social media to connect with peers', 'timeFrame': 'Baseline', 'description': "This outcome is measured using a survey developed for APPROACH-IS II by the Steering Committee, based on previous research. A sample question is 'How would you describe your experiences connecting with other people with CHD through social media?'."}, {'measure': 'Presence and burden of comorbidities', 'timeFrame': 'Baseline', 'description': 'This outcome is measured using the Charlson Comorbidity Index.'}, {'measure': 'Patient-reported socio-demographic variables (eg. age, educational level)', 'timeFrame': 'Baseline', 'description': 'Self-reported'}, {'measure': 'Medical variables by chart review (eg. diagnosis, cardiac surgeries)', 'timeFrame': 'Baseline', 'description': 'This outcome is classified according to the adult congenital heart disease anatomic and physiological (ACHD AP) classification system of Stout and colleagues.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Congenital Heart Disease', 'Quality of life', 'Patient reported outcomes', 'Patient reported experience measures', 'Geriatric phenotype'], 'conditions': ['Congenital Heart Disease']}, 'referencesModule': {'references': [{'pmid': '40962221', 'type': 'DERIVED', 'citation': '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 Sep 15:S0828-282X(25)01161-4. doi: 10.1016/j.cjca.2025.09.010. Online ahead of print.'}, {'pmid': '40579213', 'type': 'DERIVED', 'citation': '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': '34927192', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'The research aims of this study are:\n\n1. To further explore differences in a modified selection of patient-reported outcome measures (PROMs) and (as a new addition in APPROACH-IS II) explore differences in patient-reported experience measures (PREMs), by enrolling adults with congenital heart diseases in low, middle, and high income countries and including new potential explanatory variables ("Part 1").\n2. To explore the profile and healthcare needs of a subgroup of older adults with congenital heart disease, with a particular focus on investigating the frailty phenotype ("Part 2").'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Adults with congenital heart disease who are in follow-up at an adult congenital heart disease center or included in a national/regional registry.\n\nFor 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.\n\nDepending on the data collection method, sampling is at random or consecutive. Both a probability and convenience sample can be used.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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)"\n* Aged 18 years of age or older at the moment of study inclusion\n* Diagnosed with congenital heart disease before the age of 10 years\n* Follow-up at an ACHD 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'}, 'identificationModule': {'nctId': 'NCT04902768', 'acronym': 'APPROACH-IS II', 'briefTitle': 'Assessment of Patterns of Patient Reported Outcomes in Adults With Congenital Heart Disease - International Study II', 'organization': {'class': 'OTHER', 'fullName': 'KU Leuven'}, 'officialTitle': 'APPROACH-IS II: Assessment of Patterns of Patient Reported Outcomes in Adults With Congenital Heart Disease - International Study II', 'orgStudyIdInfo': {'id': 'S62537'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Adults with congenital heart disease', 'interventionNames': ['Other: This is an observational study, there is no intervention']}], 'interventions': [{'name': 'This is an observational study, there is no intervention', 'type': 'OTHER', 'description': 'This is an observational study, there is no intervention. Hence, this is not applicable.', 'armGroupLabels': ['Adults with congenital heart disease']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92093-0021', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University of California', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '94304', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': "Lucile Packard Children's Hospital and Stanford Health Care", 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}, {'zip': '32611', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Florida Health', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Taussig Heart Center of Johns Hopkins Hospital', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Boston Children's / Brigham and Women's", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '10029', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Mount Sinai Heart', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '43205', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': "Nationwide Children's Hospital", 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Health and Science University', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Philadelphia Penn Medicine', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '75390', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Southwestern Medical Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Hospital San Juan De Dios De La Plata', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'city': 'Córdoba', 'country': 'Argentina', 'facility': 'Hospital de Niños', 'geoPoint': {'lat': -31.40648, 'lon': -64.18853}}, {'city': 'Melbourne', 'country': 'Australia', 'facility': "Melbourne Children's Cardiology", 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}, {'city': 'Vienna', 'country': 'Austria', 'facility': 'Vienna General Hospital', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'city': 'Ghent', 'country': 'Belgium', 'facility': 'Ghent University Hospital', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}, {'city': 'Leuven', 'country': 'Belgium', 'facility': 'University Hospitals Leuven', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'city': 'Gaborone', 'country': 'Botswana', 'facility': 'Princess Marina Hospital', 'geoPoint': {'lat': -24.65451, 'lon': 25.90859}}, {'city': 'Ribeirão Preto', 'country': 'Brazil', 'facility': 'Hospital das Clinicas da Faculdade de Medicina de Ribeirão Preto', 'geoPoint': {'lat': -21.1775, 'lon': -47.81028}}, {'city': 'Sofia', 'country': 'Bulgaria', 'facility': 'National Heart Hospital', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'city': 'Yaoundé', 'country': 'Cameroon', 'facility': 'Clinique Medical Le Jourdain', 'geoPoint': {'lat': 3.86667, 'lon': 11.51667}}, {'city': 'Edmonton', 'country': 'Canada', 'facility': 'Mazankowski Alberta Heart Institute', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'city': 'Montreal', 'country': 'Canada', 'facility': 'Montreal Heart Institute, Université de Montréal', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'city': 'Santiago', 'country': 'Chile', 'facility': 'Intituto Nacional Del Torax', 'geoPoint': {'lat': -33.45694, 'lon': -70.64827}}, {'city': 'Manizales', 'country': 'Colombia', 'facility': 'Meintegral Clinic', 'geoPoint': {'lat': 5.0668, 'lon': -75.50684}}, {'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Copenhagen University Hospital', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}, {'city': 'Addis Ababa', 'country': 'Ethiopia', 'facility': 'College of Health sciences, Addis Ababa University', 'geoPoint': {'lat': 9.02497, 'lon': 38.74689}}, {'city': 'Bordeaux', 'country': 'France', 'facility': 'Hôpital cardiologique Haut-Leveque', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'city': 'Montpellier', 'country': 'France', 'facility': 'Montpellier University Hospital', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'city': 'Paris', 'country': 'France', 'facility': 'Hôpital Européen Georges Pompidou', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Thessaloniki', 'country': 'Greece', 'facility': 'AHEPA University Hospital', 'geoPoint': {'lat': 40.64072, 'lon': 22.93493}}, {'city': 'Kochi', 'country': 'India', 'facility': 'Amrita Institute of Medical Sciences', 'geoPoint': {'lat': 9.93988, 'lon': 76.26022}}, {'city': 'Milan', 'country': 'Italy', 'facility': 'Policlinico San Donato (IRCCS)', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'city': 'Chiba', 'country': 'Japan', 'facility': 'Chiba Cerebral and Cardiovascular Center', 'geoPoint': {'lat': 35.6, 'lon': 140.11667}}, {'city': 'Kuala Lumpur', 'country': 'Malaysia', 'facility': 'Paediatric & Congenital Heart Centre, IJN (National Heart Institute)', 'geoPoint': {'lat': 3.1412, 'lon': 101.68653}}, {'city': 'Msida', 'country': 'Malta', 'facility': 'Mater Dei Hospital', 'geoPoint': {'lat': 35.8925, 'lon': 14.48278}}, {'city': 'Groningen', 'country': 'Netherlands', 'facility': 'Centrum voor Congenital Hartafwijkingen', 'geoPoint': {'lat': 53.21917, 'lon': 6.56667}}, {'city': 'Oslo', 'country': 'Norway', 'facility': 'Oslo University Hospital, Rikshospitalet', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}, {'city': 'Karachi', 'country': 'Pakistan', 'facility': 'Aga Khan University Hospital', 'geoPoint': {'lat': 24.8608, 'lon': 67.0104}}, {'city': 'Porto', 'country': 'Portugal', 'facility': 'Reference Center of Congenital Heart Disease , University Hospital Center of São João', 'geoPoint': {'lat': 41.1485, 'lon': -8.61097}}, {'city': 'Thiès', 'country': 'Senegal', 'facility': 'Centre Hospitalier Régional de Thiès', 'geoPoint': {'lat': 14.78944, 'lon': -16.92602}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Gothenburg', 'country': 'Sweden', 'facility': 'Sahlgrenska University Hospital', 'geoPoint': {'lat': 57.70716, 'lon': 11.96679}}, {'city': 'Lund', 'country': 'Sweden', 'facility': 'Skånes Universitetssjukhus', 'geoPoint': {'lat': 55.70584, 'lon': 13.19321}}, {'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Karolinska Universitetssjukhuset', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}, {'city': 'Umeå', 'country': 'Sweden', 'facility': 'Umea University Hospital', 'geoPoint': {'lat': 63.82842, 'lon': 20.25972}}, {'city': 'Uppsala', 'country': 'Sweden', 'facility': 'Uppsala University Hospital', 'geoPoint': {'lat': 59.85882, 'lon': 17.63889}}, {'city': 'Bern', 'country': 'Switzerland', 'facility': 'University Hospital Bern', 'geoPoint': {'lat': 46.94809, 'lon': 7.44744}}, {'city': 'Geneva', 'country': 'Switzerland', 'facility': 'Hôpitaux Universitaires de Genève', 'geoPoint': {'lat': 46.20222, 'lon': 6.14569}}, {'city': 'Lausanne', 'country': 'Switzerland', 'facility': 'Centre Hospitalier universitaire vaudois', 'geoPoint': {'lat': 46.516, 'lon': 6.63282}}, {'city': 'Taipei', 'country': 'Taiwan', 'facility': 'National Taiwan University Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'city': 'Bornova', 'country': 'Turkey (Türkiye)', 'facility': 'Ege University Health Application and Research Center, Cardiology Department', 'geoPoint': {'lat': 38.47921, 'lon': 27.2399}}, {'city': 'London', 'country': 'United Kingdom', 'facility': "Royal Brompton Hospital, Royal Brompton & Harefield Hospitals, Guy's and St Thomas' NHS Foundation Trust", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'city': 'Newcastle', 'country': 'United Kingdom', 'facility': 'Freeman Hospital, Newcastle Upon Tyne Hospitals NHS Foundation Trust', 'geoPoint': {'lat': 54.21804, 'lon': -5.88979}}], 'overallOfficials': [{'name': 'Philip Moons, PhD, RN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Professor in Healthcare Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Well-argued and reasonable requests can be directed to the Principal Investigator (Prof. Philip Moons) of the study.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'KU Leuven', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr. Philip Moons', 'investigatorFullName': 'Philip Moons', 'investigatorAffiliation': 'KU Leuven'}}}}