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临床试验/NCT02898493
NCT02898493Unknown不适用

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

Centre Hospitalier Universitaire de la Réunion1 个研究点 分布在 1 个国家目标入组 750 人开始时间: 2016年9月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
750
试验地点
1
主要终点
Internal Consistency (IC) assessed as Cronbach's Alpha Value

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Internal Consistency (IC) assessed as Cronbach's Alpha Value

时间窗: 1 day (inclusion day)

次要结局

  • Test-retest Reliability(3-4 weeks)

研究者

发起方
Centre Hospitalier Universitaire de la Réunion
申办方类型
Other
责任方
Sponsor

研究点 (1)

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