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临床试验/NCT04537039
NCT04537039撤回不适用

Prospective, Multicentric Study, Aiming to Assess the Relevance of a Frailty Screening by Home Care Services

Elsan1 个研究点 分布在 1 个国家开始时间: 2020年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
发起方
试验地点
1
主要终点
Evaluation of the performance of the SEGA-A test, used by professionals in the home care services, as a screening test for frailty of people over 65 living at home.

研究概览

简要总结

An improvement in professional practices on the topic of frailty is desirable as much for ambulatory care teams (professionals in home care services) than for hospital care teams (medical and paramedical). Geriatric prevention, screening for frailty, are major challenges for the years to come and require involvement and a know-how.

The main hypothesis is that the screening of the frailty of the elderly, by the home care services is relevant and reliable, therefore making it possible to detect a state of frailty and organize preventive care at the earliest.

The objectives of this research work are:

  • to demonstrate that the use of a questionnaire, simple and already validated for a medical use, can be administered by home care services with just as much relevance,
  • to democratize the detection of frailty by demonstrating that home care services have an important role to play in terms of screening and therefore an equally important impact in terms of public health,
  • to recall the importance of screening in medical practice, including for the elderly.

详细描述

The continued increase in life expectancy is one of the most significant achievements of these years in Europe: while in 1960 life expectancy was 73.6 years for women and 67 years for men, in 2010 it was significantly higher, respectively 84.8 years and 78.1 years. Total life expectancy is increasing, but disability-free life expectancy is declining.

Thus, the years of life gained would now be accompanied by functional limitations, activity restrictions and degradation of autonomy. One of the challenges of our society, promoted as part of the European Innovation Partnership for Active and Healthy Aging as well as in the National Health Strategy 2018-2022, is the prevention of disabilities and age-related dependence by ensuring that our patients can not only live longer, but also lead a healthy, active and independent life.

The vast majority of older people live at home without significant disability, including in the most advanced age groups. These elderly pauci- or mono-pathological persons evolve in a manner comparable to younger adults in acute illness, hospitalization or during physical and / or psychological stress, the so-called "fragile" elderly unmask an underlying state of vulnerability and may enter into dependency.

In 2011, the French Society of Geriatrics and Gerontology (SFGG) adopted the following definition of frailty: "Frailty is a clinical syndrome. It reflects a decrease in physiological capacity reserve which alters the mechanisms of adaptation to stress. Its clinical expression is modulated by comorbidities and by psychological, social, economic and behavioral. Frailty syndrome is a marker of risk of mortality and pejorative events, including disabilities, falls, hospitalization and institutionalization. Age is a major determinant of frailty [...]. Addressing the determinants of frailty can reduce or delay its consequences. Thus, fragility would be part of a process potentially reversible ".

According to the latest data from the SHARE survey (Survey on Health, Aging and Retirement in Europe) which is a multidisciplinary longitudinal Survey involving more than 80,000 Europeans aged over 50 with collection of data on health status, social situation (family, mutual aid, social networks) and economic (employment, retirement, wealth), frailty represents in France 3.2% of people aged 50 to 64, and 15% of people over 65. Other data of interest, 43% of people over 65 are "pre-fragile".

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

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

入选标准

  • Living at home.
  • Functional independence preserved (ADL ≥ 5/6).
  • Intervention of a Home Assistance Service (SAAD, SSIAD, carer, liberal nurse at home, etc.) for any reason.
  • Signature of informed consent for the participation to the study.
  • Affiliation to a social security scheme or beneficiaries of such a scheme.

排除标准

  • Independency not preserved (ADL <5).
  • Inability to understand the questions of the SEGA-A grid.
  • Refusal to participate in the study expressed by the patient.
  • Patients under guardianship or curatorship.
  • Patient under end-of-life care.

结局指标

主要结局

Evaluation of the performance of the SEGA-A test, used by professionals in the home care services, as a screening test for frailty of people over 65 living at home.

时间窗: Date of the visit of the home care services.

To measure the performance of the SEGA part A screening test (sensitivity, specificity, likelihood) used by the Home Care Services in screening for frailty, by comparing to the gold standard of the diagnosis of frailty represented by the Fried score, carried out by a doctor trained in geriatrics.

次要结局

  • Epidemiology of the frailty of people in the care of the home care services and their relatives caregivers living at home (% robust, pre-fragile and fragile; to be done by age group).(Through study completion, an average of 2 years.)
  • To look for the elements associated with the diagnosis of frailty in order to have warning signs that should lead to a screening.(Through study completion, an average of 2 years.)
  • To evaluate the subjective feeling of the existence of frailty by home care services.(Date of the visit of the home care services.)
  • To measure the feasibility of carrying out the screening test in current practice by home care services in terms of cost (financial and human) and acceptability.(Date of the visit of the home care services.)

研究者

发起方
Elsan
申办方类型
Other
责任方
Sponsor

研究点 (1)

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