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临床试验/NCT04085432
NCT04085432已完成不适用

Validation Study for a Frailty Self Assessment Tool in Retirees Aged 70 and Over

International Longevity Centre France2 个研究点 分布在 1 个国家目标入组 5,134 人开始时间: 2019年10月3日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
5,134
试验地点
2
主要终点
Frailty and pre-frailty diagnosis rate

研究概览

简要总结

The number of elderly is increasing throughout of the world. Aging is associated with increasing diseases that may be preventable. Over the last decades, frailty has emerged as one of the major risk factors for loss of autonomy. Frailty can be reversed through appropriate interventions particularly when they are implemented early. Therefore, early detection of frailty is a major objective. The goal of this study is to identify elderly subjects aged 70 years and over at the early stage of frailty by using a self administered questionnaire sent to the participant by mail. The results of the self assessment will be compared to the Fried criteria collected by a clinical examination conducted by a healthcare Professional blinded to the self assessment results.

详细描述

Five thousands (5000) retirees aged 70 and over will be randomly selected from National Retirement Pension Institute (CNAV) retirees (2500 living in Paris and 2500 living in Toulouse). They will receive a letter from the CNAV explaining the study approach and a separate self-assessment frailty questionnaire to be filled in by the retirees at home and sent back in a pre-paid envelope to International Longevity Centre France (ILC-France).

Retirees who have accepted the home assessment are examined by a healthcare professional, blinded to the results of self-administered questionnaire, using the Fried's frailty criteria in order to confirm or infirm the diagnosis of frailty.

The General practitioner will be informed of the investigation results in order to set up a personalized prevention plan.

ILC-France will anonymize both the self-administered questionnaires and the Fried assessments and send them to the Mixed Research Unit (UMR) 1027 in Toulouse.

Comparison of the Fried assessment results with those of the self-questionnaire will confirm the metrological characteristics (false negative, false positive, sensitivity, specificity, predictive value) of the questionnaire.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Other

入排标准

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

入选标准

  • Retirees from the National Old-Age Insurance Fund
  • Aged 70 or older,
  • Living at home
  • Representatives of the general population

排除标准

  • Institutionalized retirees
  • Retirees receiving the Personalised Allowance for Autonomy
  • Retirees who enrolled in previous studies

结局指标

主要结局

Frailty and pre-frailty diagnosis rate

时间窗: October 2019 to August 2020

Frailty and pre-frailty diagnosis rate are detected by self administered questionnaire and confirmed by the Fried's frailty phenotype assessment

次要结局

  • Prevalence of frailty by age and gender(October 2019 to August 2020)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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