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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 (CreoQol)

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ClinicalTrials.gov Identifier: NCT02898493
Recruitment Status : Recruiting
First Posted : September 13, 2016
Last Update Posted : September 6, 2018
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease
Diabetes Mellitus, Type 2

Study Type : Observational
Estimated Enrollment : 750 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official 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
Actual Study Start Date : September 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Internal Consistency (IC) assessed as Cronbach's Alpha Value [ Time Frame: 1 day (inclusion day) ]

Secondary Outcome Measures :
  1. Test-retest Reliability [ Time Frame: 3-4 weeks ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Type II diabetic patients seen in the department of diabetology at the University Hospital
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02898493


Contacts
Contact: Laetitia HUIART, DR 0262906882 laetitia.huiart@chu-reunion.fr
Contact: Sophie LAFARGE 0262359491 sophie.lafarge@chu-reunion.fr

Locations
France
University Hospital of Reunion Island Recruiting
Saint Denis, Reunion Island, France, 97400
Contact: LAETITIA HUIART, DR    0262906882    laetitia.huiart@chu-reunion.fr   
Contact: sophie LAFARGE    0262359491    sophie.lafarge@chu-reunion.fr   
Principal Investigator: Xavier DEBUSSCHE, DR         
Principal Investigator: Nathalie LE MOULLEC, DR         
Sponsors and Collaborators
Centre Hospitalier Universitaire de la Réunion

Responsible Party: Centre Hospitalier Universitaire de la Réunion
ClinicalTrials.gov Identifier: NCT02898493     History of Changes
Other Study ID Numbers: 2013/CHU/09
First Posted: September 13, 2016    Key Record Dates
Last Update Posted: September 6, 2018
Last Verified: September 2018

Keywords provided by Centre Hospitalier Universitaire de la Réunion:
Validation of questionnaire
Quality of life

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases