Clinical trial NCT04537039: Home Care Services Screening for Frailty.
Official title: Prospective, Multicentric Study, Aiming to Assess the Relevance of a Frailty Screening by Home Care Services
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Frailty
Lead sponsor: Elsan
Sponsor class: OTHER
First posted: 2020-09-03
Enrollment: 0
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed description: 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".

Thus, being able to identify fragility early is a major issue in order to implement corrective actions and avoid or at least delay entry into addiction. To do so, several simple primary care screening tools have been developed, like self-assessment such as the FiND8 self-questionnaire or tools intended to be used by physicians such as the FRAIL tool from Morley or the tool for identifying the frailty of the gerontopole of Toulouse.

These screening strategies remain mainly for the time in the medical field while home care services (SAD), daily actors in the elderly person life, are still too little involved. The development of Home Care Frailty Scale, a 29-item multidimensional assessment tool for the risk of decline to dependency, based on data from the interRAI (Resident Assessment Instrument), however, demonstrates that SAD represent an interesting screening strategy.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: 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.
timeFrame: Date of the medical visit with the geriatrician.
measure: 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.
timeFrame: Date of the visit of the home care services.
Secondary outcomes:
measure: 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.
timeFrame: Date of the visit of the home care services.
measure: 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.
timeFrame: Date of the visit of the home care services.
measure: 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.
timeFrame: Date of the visit of the home care services.
measure: To evaluate the subjective feeling of the existence of frailty by home care services.
timeFrame: Date of the visit of the home care services.
measure: 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).
timeFrame: Through study completion, an average of 2 years.
measure: To look for the elements associated with the diagnosis of frailty in order to have warning signs that should lead to a screening.
timeFrame: Through study completion, an average of 2 years.
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: Clinique la chataigneraie
Study officials:
References:
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