Diabetes Mellitus, Type 2 Clinical Trial
— CreoQolOfficial 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
| NCT number | NCT02898493 |
| Other study ID # | 2013/CHU/09 |
| Secondary ID | |
| Status | Recruiting |
| Phase | |
| First received | |
| Last updated | |
| Start date | September 2016 |
| Est. completion date | December 2019 |
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.
| Status | Recruiting |
| Enrollment | 750 |
| Est. completion date | December 2019 |
| Est. primary completion date | December 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| France | University Hospital of Reunion Island | Saint Denis | Reunion Island |
| Lead Sponsor | Collaborator |
|---|---|
| Centre Hospitalier Universitaire de la Réunion |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Internal Consistency (IC) assessed as Cronbach's Alpha Value | 1 day (inclusion day) | ||
| Secondary | Test-retest Reliability | 3-4 weeks |
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