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

Results pending

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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Recruitment Status

UNKNOWN

Total Enrollment

750 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-09-30

Study Completion Date

2019-12-31

Brief Summary

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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

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Conditions

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Diabetes Mellitus, Type 2

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de la Réunion

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University Hospital of Reunion Island

Saint-Denis, Reunion Island, France

Site Status RECRUITING

Countries

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France

Central Contacts

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Laetitia HUIART, DR

Role: CONTACT

0262906882

Sophie LAFARGE

Role: CONTACT

0262359491

Facility Contacts

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LAETITIA HUIART, DR

Role: primary

0262906882

sophie LAFARGE

Role: backup

0262359491

Other Identifiers

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2013/CHU/09

Identifier Type: -

Identifier Source: org_study_id

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