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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02898493

Acronym

CreoQol

Enrollment

750

Registered

2016-09-13

Start date

2016-09-30

Completion date

2019-12-31

Last updated

2018-09-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 2

Keywords

Validation of questionnaire, Quality of life

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
Test-retest Reliability	3-4 weeks

Countries

France

Contacts

Primary ContactLaetitia HUIART, DR

laetitia.huiart@chu-reunion.fr0262906882

Backup ContactSophie LAFARGE

sophie.lafarge@chu-reunion.fr0262359491

Outcome results