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 (CreoQol)
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|ClinicalTrials.gov Identifier: NCT02898493|
Recruitment Status : Recruiting
First Posted : September 13, 2016
Last Update Posted : September 6, 2018
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.
Among 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.
In 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.
Investigators 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.
|Condition or disease|
|Diabetes Mellitus, Type 2|
|Study Type :||Observational|
|Estimated Enrollment :||750 participants|
|Official 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|
|Actual Study Start Date :||September 2016|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2019|
- Internal Consistency (IC) assessed as Cronbach's Alpha Value [ Time Frame: 1 day (inclusion day) ]
- Test-retest Reliability [ Time Frame: 3-4 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02898493
|Contact: Laetitia HUIART, DRemail@example.com|
|Contact: Sophie LAFARGEfirstname.lastname@example.org|
|University Hospital of Reunion Island||Recruiting|
|Saint Denis, Reunion Island, France, 97400|
|Contact: LAETITIA HUIART, DR 0262906882 email@example.com|
|Contact: sophie LAFARGE 0262359491 firstname.lastname@example.org|
|Principal Investigator: Xavier DEBUSSCHE, DR|
|Principal Investigator: Nathalie LE MOULLEC, DR|