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

• Conditions: Diabetes Mellitus, Type 2

• Registration Number: NCT02898493
• Lead Sponsor: Centre Hospitalier Universitaire de la Réunion

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-09
• Study First Submitted: 2016-09-08
• Study First Submitted QC: 2016-09-12
• Study First Posted: 2016-09-13
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-04
• Last Update Posted: 2018-09-06
• Primary Completion: 2019-12
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 750

Inclusion Criteria

• male or female ≥ 18 years of age
• 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

• not able to understand and follow the instructions
• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Internal Consistency (IC) assessed as Cronbach's Alpha Value	1 day (inclusion day)

Secondary Outcome Measures

Name	Time	Method
Test-retest Reliability	3-4 weeks

Trial Locations

Locations (1)

University Hospital of Reunion Island; 🇫🇷 Saint Denis, Reunion Island, France