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
NCT ID: NCT02898493
Last Updated: 2018-09-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
750 participants
OBSERVATIONAL
2016-09-30
2019-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
CROSS_SECTIONAL
Eligibility Criteria
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Inclusion Criteria
* type II diabetes diagnosed more than 1 year ago
* creole speaking
* living on the island for more than 5 years
* agreed and signed the informed consent form
Exclusion Criteria
* patients with proven cognitive issues which do not make possible to complete questionnaire
* patients with current acute and serious complications associated with diabetes
* medical history of stroke with physical or neurological damage
* patients already involved in the study
18 Years
ALL
No
Sponsors
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Centre Hospitalier Universitaire de la Réunion
OTHER
Responsible Party
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Locations
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University Hospital of Reunion Island
Saint-Denis, Reunion Island, France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2013/CHU/09
Identifier Type: -
Identifier Source: org_study_id
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