NCT05978245招募中不适用
Obtaining Reliable Linguistic and Cultural Validation of the Questionnaires Cargier Bruden Inventony (CBI) and Zarit-12, Translate From English for Use in France
Centre Hospitalier de Saint-Denis1 个研究点 分布在 1 个国家目标入组 264 人开始时间: 2023年11月22日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 264
- 试验地点
- 1
- 主要终点
- French-language linguistic and cultural validation of caregiver burden questionnaires (CBI) in a population of neurological patients
研究概览
简要总结
To validate the 2 questionnaires ZARIT-12 and CBI it is important to go through several stages:
- translation stage : during this stage there will be a meeting of experts to Validate the test version in French by 4 Bilingual translators of the French and English mother tongue.
- pilot stage : recruit a number of 30 neurological patients' caregivers, in order to validate the comprehension, thus obtaining the final version of the questionnaire.
- Validation stage : the two questionnaires have been validated, in this stage there should be a recruitment of 264 participants for the CBI questionnaire and 120 participants for the ZARIT-12 questionnaire, and these 2 questionnaires will be deliver to the participant on the same day.
- The first questionnary will have to be filled the day they get the questionnary (day 1).
- The second one must be completed and sent fourteen days later (day 14).
详细描述
To validate the 2 questionnaires ZARIT-12 and CBI it is important to go through several stages:
- translation stage : during this stage there will be a meeting of experts to Validate the test version in French by 4 Bilingual translators of the French and English mother tongue.
- pilot stage : recruit a number of 30 neurological patients' caregivers, in order to validate the comprehension, thus obtaining the final version of the questionnaire.
- Validation stage : the two questionnaires have been validated, in this stage there should be a recruitment of 264 participants for the CBI questionnaire and 120 participants for the ZARIT-12 questionnaire, and these 2 questionnaires will be deliver to the participant on day 1. The first questionnary will have to be filled on day 1 and the second one must be completed and sent fourteen days later (so on day 14)
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Caregivers (family or friend) of patients followed for a central neurological pathology (MS, BM, Parkinson's, stroke, congenital (Spina...)) or peripheral (ponytail, peripheral neuropathies)
- •Adult caregivers (age ≥ 18 years), regardless of the patient's age
- •Francophone caregivers (ability to read, write and understand French)
- •Caregivers who did not object to the use of their data or the patient's data for research
排除标准
- •- Professional caregivers
- •caregivers of patients being cared for with a pathology other than neurological
- •Minor caregivers (age ≤ 17 years)
- •Caregivers with no or poor French language skills
- •Caregivers who refused to participate in the research
结局指标
主要结局
French-language linguistic and cultural validation of caregiver burden questionnaires (CBI) in a population of neurological patients
时间窗: two days (day one and day fourteen)
CBI questionnaire
French-language linguistic and cultural validation of caregiver burden questionnaires (Zarit-12) in a population of neurological patients
时间窗: two days (day one and day fourteen)
ZARIT-12
次要结局
- Identifying populations at higher risk of burden (ZARIT-12)(two days (day one and day fourteen))
- Identifying populations at higher risk of burden (CBI)(two days (day one and day fourteen))
- Identification of risk factors for caregiver's burden (ZARIT-12)(two days (day one and day fourteen))
- Identification of risk factors for caregiver's burden (CBI)(two days (day one and day fourteen))
研究者
研究点 (1)
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