Ignite Creation Date:
2025-12-25 @ 12:58 AM
Ignite Modification Date:
2026-02-26 @ 12:05 PM
Study NCT ID:
NCT02898493
Status:
UNKNOWN
Last Update Posted:
2018-09-06
First Post:
2016-09-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Translation, Cultural Adaptation and Validation of the Creole Versions of the EQ-5D and the SF-36 Questionnaires in Patients With Type II Diabetes in Reunion Island, Martinique and Guadeloupe
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 750}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-09-04', 'studyFirstSubmitDate': '2016-09-08', 'studyFirstSubmitQcDate': '2016-09-12', 'lastUpdatePostDateStruct': {'date': '2018-09-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-09-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Internal Consistency (IC) assessed as Cronbach's Alpha Value", 'timeFrame': '1 day (inclusion day)'}], 'secondaryOutcomes': [{'measure': 'Test-retest Reliability', 'timeFrame': '3-4 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Validation of questionnaire', 'Quality of life'], 'conditions': ['Diabetes Mellitus, Type 2']}, 'descriptionModule': {'briefSummary': 'The evaluation of quality of life in health is particularly important for measuring the impact of the chronic diseases. The scales of measure constitute the main measurement tool in clinical trials because of their psychometrics properties and of their ease of use.\n\nAmong these scales, the 36-Item Short Form Survey (SF-36) and the EuroQol five dimensions questionnaire ( EQ-5D) were widely validated in various populations, of which the population of the diabetics patients. Both scales have validated versions in French.\n\nIn the Antilles and in Reunion Island, diabetes is a frequent pathology and is the subject of many clinical and epidemiological trials. One of the difficulties encountered during the implementation of these studies is the absence of measurement tools validated for these populations.\n\nInvestigators thus suggest, within a common workgroup uniting Guadeloupe, Martinique and Reunion Island, adapting and validating these scales according to an identical procedure in Creole from Guadeloupe, from Martinique and from Reunion Island and validating the French versions of these scales in their populations of type II diabetics patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Type II diabetic patients seen in the department of diabetology at the University Hospital', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* male or female ≥ 18 years of age\n* type II diabetes diagnosed more than 1 year ago\n* creole speaking\n* living on the island for more than 5 years\n* agreed and signed the informed consent form\n\nExclusion Criteria:\n\n* not able to understand and follow the instructions\n* patients with proven cognitive issues which do not make possible to complete questionnaire\n* patients with current acute and serious complications associated with diabetes\n* medical history of stroke with physical or neurological damage\n* patients already involved in the study'}, 'identificationModule': {'nctId': 'NCT02898493', 'acronym': 'CreoQol', 'briefTitle': 'Translation, Cultural Adaptation and Validation of the Creole Versions of the EQ-5D and the SF-36 Questionnaires in Patients With Type II Diabetes in Reunion Island, Martinique and Guadeloupe', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de la Réunion'}, 'officialTitle': 'Translation, Cultural Adaptation and Validation of the Creole Versions of the EQ-5D and the SF-36 Questionnaires in Patients With Type II Diabetes in Reunion Island, Martinique and Guadeloupe', 'orgStudyIdInfo': {'id': '2013/CHU/09'}}, 'contactsLocationsModule': {'locations': [{'zip': '97400', 'city': 'Saint-Denis', 'state': 'Reunion Island', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'LAETITIA HUIART, DR', 'role': 'CONTACT', 'email': 'laetitia.huiart@chu-reunion.fr', 'phone': '0262906882'}, {'name': 'sophie LAFARGE', 'role': 'CONTACT', 'email': 'sophie.lafarge@chu-reunion.fr', 'phone': '0262359491'}, {'name': 'Xavier DEBUSSCHE, DR', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Nathalie LE MOULLEC, DR', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University Hospital of Reunion Island', 'geoPoint': {'lat': 48.93564, 'lon': 2.35387}}], 'centralContacts': [{'name': 'Laetitia HUIART, DR', 'role': 'CONTACT', 'email': 'laetitia.huiart@chu-reunion.fr', 'phone': '0262906882'}, {'name': 'Sophie LAFARGE', 'role': 'CONTACT', 'email': 'sophie.lafarge@chu-reunion.fr', 'phone': '0262359491'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de la Réunion', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}