Home Care Services Screening for Frailty.

December 27, 2023 updated by: Elsan

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Clermont-Ferrand, France
        • Clinique la Chataigneraie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: All the participants.
This study only includes 1 arm.
Diagnostic test: Frailty screening for people over 65 living at home.
The home care services will carry out the SEGA-A test.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: Date of the medical visit with the geriatrician.
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.
Date of the medical visit with the geriatrician.
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.
Time Frame: 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.
Date of the visit of the home care services.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: Date of the visit of the home care services.
To assess the feasibility of the screening test, the estimate duration of the SEGA-A grid will be measured in minutes.
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.
Time Frame: Date of the visit of the home care services.
To assess the feasibility of the screening test, the acceptability by the patient will be asked. This measurement will be given using a feasibility and acceptability questionnaire.
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.
Time Frame: Date of the visit of the home care services.
To assess the feasibility of the screening test, the acceptability by the professionnal will be filled in. This measurement will be given using a feasibility and acceptability questionnaire. This measurement will be done only once per professionnal regardless of the number of patients he took care of.
Date of the visit of the home care services.
To evaluate the subjective feeling of the existence of frailty by home care services.
Time Frame: Date of the visit of the home care services.
The subjective feeling of the state of frailty will be evaluated by the use of a numerical scale from 0 to 10, the score 0 corresponding to the perception of a robust state and the score 10 to that of a very fragile condition.
Date of the visit of the home care services.
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).
Time Frame: Through study completion, an average of 2 years.
The epidemiology of the frailty of people living at home for whom a home care service is involved will be calculated as a percentage and absolute value of robust, pre-fragile and fragile, according to the criteria determined by the Fried test.
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.
Time Frame: Through study completion, an average of 2 years.
In order to find the guiding elements that would lead to screening of the frailty state, it will be a question of analyzing the correlation between the diagnosed state of frailty and the different medico-social data collected (medical background information).
Through study completion, an average of 2 years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Elsan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2020

Primary Completion (Estimated)

November 1, 2022

Study Completion (Estimated)

November 1, 2022

Study Registration Dates

First Submitted

July 30, 2020

First Submitted That Met QC Criteria

August 28, 2020

First Posted (Actual)

September 3, 2020

Study Record Updates

Last Update Posted (Estimated)

January 1, 2024

Last Update Submitted That Met QC Criteria

December 27, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FRAILTY

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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