Cross-cultural and Psychometric Validation of the RESVECH 2.0 Scale for the Assessment of Chronic Wounds in the French West Indies.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Cultural adaptation of the RESVECH 2.0 scale.
研究概览
简要总结
Chronic wound of lower limb. In developed countries, the prevalence of chronic wounds is linked to the ageing of the population and the increase in chronic diseases such as diabetes, obesity and cardiovascular disease. Consequence: amputations of lower limb. The prevalence of chronic wounds is also variable across the globe. In addition, chronic wounds are associated with psychosocial problems such as poor quality of life, loss of professional activity and progressive de-socialization of patients. To improve the quality of care we need in french wound assessment tools validated scientifically like the RESVECH 2.0 scale, validated in the Spanish language.
详细描述
The VALRESCIC study aims to perform a cross-cultural and psychometric validation of the RESVECH 2.0 scale in order to be able to use it for monitoring wounds in both hospital and primary care settings in the French West Indies.
The RESVECH 2.0 scale is a heterogeneous scale to monitor the evolution of a chronic wound. This scale was created in 2010 and consists of 6 items with response modalities ranging from 5 to 14. The interpretation of the scale parameters may differ depending on the cultural context. The RESVECH 2.0 scale has been validated in the Spanish language (in Spain and Colombia) to assess the progress towards healing of pressure ulcers and chronic wounds of the lower limbs.
For the cross-cultural evaluation we will follow Beaton's methodology, which includes: translation, synthesis, retro-translation, expert committee review and pre-testing. For the psychometric validation, the following parameters will be measured: Feasibility and acceptability, validity, reliability, and sensitivity to change.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with at least one chronic wound of the lower limbs admitted to the M@diCICAT® healing centre.
- •Patients agreeing to participate in the study
- •Patients affiliated to a social security scheme
排除标准
- •Patients with critical ischemia of the lower limb concerned
- •Patients under legal protection measures (guardianship, curatorship, safeguard of justice) and persons deprived of liberty
研究组 & 干预措施
Patients with chronic wound of the lower limbs
Passing of the scale when the patient will come at the hospital for his routine health care visit in M@diCICAT center
干预措施: Patients with chronic wound of the lower limbs (Other)
结局指标
主要结局
Cultural adaptation of the RESVECH 2.0 scale.
时间窗: Before the start of recruitment
Validation of scale RESVECH 2.0 translation in french language depending on the cultural context in French West Indies
Psychometric validation of the RESVECH 2.0 scale.
时间窗: 15 days post inclusion
Scientific validation of the french version of the scale RESVECH 2.0 in French West Indies
次要结局
未报告次要终点