FrailtyNCT04537039
Home Care Services Screening for Frailty.
A study testing Frailty screening for people over 65 living at home. in people with Frailty, run by Elsan at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Frailty
- What is being tested?
- Frailty screening for people over 65 living at home.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2020to Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Frailty
- Being tested
- Frailty screening for people over 65 living at home.
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Frailty screening for people over 65 living at home.Diagnostic test
The home care services will carry out the SEGA-A test.
| Study group | Role | What they receive |
|---|---|---|
| All the participants. | Other | This study only includes 1 arm. Receives: Diagnostic Test: Frailty screening for people over 65 living at home. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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.
Measured: 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.
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.
Measured: Date of the visit of the home care services.
Secondary outcomes (6)
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.
To assess the feasibility of the screening test, the estimate duration of the SEGA-A grid will be measured in minutes.
Measured: 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.
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.
Measured: 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.
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.
Measured: Date of the visit of the home care services.
To evaluate the subjective feeling of the existence of frailty by 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.
Measured: 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).
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.
Measured: 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.
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).
Measured: Through study completion, an average of 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2020
- Study start1 Sep 2020 (estimated)
- Primary completionNov 2022 (estimated)
- Study completionNov 2022 (estimated)
Why it stopped: The COVID outbreak did not allow home visits
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for FrailtyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elsan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04537039
- Sponsor's protocol ID
- FRAILTY
- Status last verified
- Dec 2023
- First submitted
- 30 Jul 2020
- Last updated
- 2 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Morley JE, Malmstrom TK, Miller DK. A simple frailty questionnaire (FRAIL) predicts outcomes in middle aged African Americans. J Nutr Health Aging. 2012 Jul;16(7):601-8. doi: 10.1007/s12603-012-0084-2.
PubMed 22836700Vellas B, Balardy L, Gillette-Guyonnet S, Abellan Van Kan G, Ghisolfi-Marque A, Subra J, Bismuth S, Oustric S, Cesari M. Looking for frailty in community-dwelling older persons: the Gerontopole Frailty Screening Tool (GFST). J Nutr Health Aging. 2013 Jul;17(7):629-31. doi: 10.1007/s12603-013-0363-6.
PubMed 23933875Rolland Y, Benetos A, Gentric A, Ankri J, Blanchard F, Bonnefoy M, de Decker L, Ferry M, Gonthier R, Hanon O, Jeandel C, Nourhashemi F, Perret-Guillaume C, Retornaz F, Bouvier H, Ruault G, Berrut G. [Frailty in older population: a brief position paper from the French society of geriatrics and gerontology]. Geriatr Psychol Neuropsychiatr Vieil. 2011 Dec;9(4):387-90. doi: 10.1684/pnv.2011.0311. French.
PubMed 22182814Borsch-Supan A, Brandt M, Hunkler C, Kneip T, Korbmacher J, Malter F, Schaan B, Stuck S, Zuber S; SHARE Central Coordination Team. Data Resource Profile: the Survey of Health, Ageing and Retirement in Europe (SHARE). Int J Epidemiol. 2013 Aug;42(4):992-1001. doi: 10.1093/ije/dyt088. Epub 2013 Jun 18.
PubMed 23778574Vellas B, Cestac P, Moley JE. Implementing frailty into clinical practice: we cannot wait. J Nutr Health Aging. 2012 Jul;16(7):599-600. doi: 10.1007/s12603-012-0096-y. No abstract available.
PubMed 22836699Cesari M, Demougeot L, Boccalon H, Guyonnet S, Abellan Van Kan G, Vellas B, Andrieu S. A self-reported screening tool for detecting community-dwelling older persons with frailty syndrome in the absence of mobility disability: the FiND questionnaire. PLoS One. 2014 Jul 7;9(7):e101745. doi: 10.1371/journal.pone.0101745. eCollection 2014.
PubMed 24999805Morris JN, Howard EP, Steel KR. Development of the interRAI home care frailty scale. BMC Geriatr. 2016 Nov 21;16(1):188. doi: 10.1186/s12877-016-0364-5.
PubMed 27871235Sieliwonczyk E, Perkisas S, Vandewoude M. Frailty indexes, screening instruments and their application in Belgian primary care. Acta Clin Belg. 2014 Aug;69(4):233-9. doi: 10.1179/2295333714Y.0000000027. Epub 2014 Apr 29.
PubMed 24773077Zulfiqar AA. Identification of frailty by the use of the SEGAm scale (part A) in geriatrical consultation. Geriatr Psychol Neuropsychiatr Vieil. 2018 Sep 1;16(3):269-277. doi: 10.1684/pnv.2018.0740.
PubMed 29976541Oubaya N, Drame M, Novella JL, Quignard E, Cunin C, Jolly D, Mahmoudi R. Screening for frailty in community-dwelling elderly subjects: Predictive validity of the modified SEGA instrument. Arch Gerontol Geriatr. 2017 Nov;73:177-181. doi: 10.1016/j.archger.2017.07.026. Epub 2017 Aug 4.
PubMed 28822918Feck E, Zulfiqar AA. [Screening of frailty in family practice by the modified SEGA grid]. Rev Med Liege. 2018 Oct;73(10):513-518. French.
PubMed 30335257Tardieu E, Mahmoudi R, Novella JL, Oubaya N, Blanchard F, Jolly D, Drame M. [External validation of the short emergency geriatric assessment (SEGA) instrument on the SAFES cohort]. Geriatr Psychol Neuropsychiatr Vieil. 2016 Mar;14(1):49-55. doi: 10.1684/pnv.2016.0592. French.
PubMed 27005336Woo J, Yu R, Wong M, Yeung F, Wong M, Lum C. Frailty Screening in the Community Using the FRAIL Scale. J Am Med Dir Assoc. 2015 May 1;16(5):412-9. doi: 10.1016/j.jamda.2015.01.087. Epub 2015 Feb 24.
PubMed 25732832
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multicentric Study, Aiming to Assess the Relevance of a Frailty Screening by Home Care Services
- ClinicalTrials.gov ID
- NCT04537039
- Acronym / sponsor ID
- FRAILTY
- Conditions
- Frailty
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The COVID outbreak did not allow home visits
- Enrolment
- 0 participants (actual)
- Lead sponsor
- ElsanUniversity, hospital or other
- Study start
- 1 Sep 2020 (estimated)
- Primary completion
- Nov 2022 (estimated)
- Study completion
- Nov 2022 (estimated)
- First posted
- 3 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All the participants. | Other | Diagnostic Test: Frailty screening for people over 65 living at home.This study only includes 1 arm. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Frailty screening for people over 65 living at home.The home care services will carry out the SEGA-A test. | Diagnostic test | All the participants. |
Primary outcome
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.
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.
6 secondary outcomes
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 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 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 evaluate the subjective feeling of the existence of frailty by home care services.
Time frame: 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.
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2024.
- Background: PubMed 22836700Morley JE, Malmstrom TK, Miller DK. A simple frailty questionnaire (FRAIL) predicts outcomes in middle aged African Americans. J Nutr Health Aging. 2012 Jul;16(7):601-8. doi: 10.1007/s12603-012-0084-2.
- Background: PubMed 23933875Vellas B, Balardy L, Gillette-Guyonnet S, Abellan Van Kan G, Ghisolfi-Marque A, Subra J, Bismuth S, Oustric S, Cesari M. Looking for frailty in community-dwelling older persons: the Gerontopole Frailty Screening Tool (GFST). J Nutr Health Aging. 2013 Jul;17(7):629-31. doi: 10.1007/s12603-013-0363-6.
- Background: PubMed 22182814Rolland Y, Benetos A, Gentric A, Ankri J, Blanchard F, Bonnefoy M, de Decker L, Ferry M, Gonthier R, Hanon O, Jeandel C, Nourhashemi F, Perret-Guillaume C, Retornaz F, Bouvier H, Ruault G, Berrut G. [Frailty in older population: a brief position paper from the French society of geriatrics and gerontology]. Geriatr Psychol Neuropsychiatr Vieil. 2011 Dec;9(4):387-90. doi: 10.1684/pnv.2011.0311. French.
- Background: PubMed 23778574Borsch-Supan A, Brandt M, Hunkler C, Kneip T, Korbmacher J, Malter F, Schaan B, Stuck S, Zuber S; SHARE Central Coordination Team. Data Resource Profile: the Survey of Health, Ageing and Retirement in Europe (SHARE). Int J Epidemiol. 2013 Aug;42(4):992-1001. doi: 10.1093/ije/dyt088. Epub 2013 Jun 18.
- Background: PubMed 22836699Vellas B, Cestac P, Moley JE. Implementing frailty into clinical practice: we cannot wait. J Nutr Health Aging. 2012 Jul;16(7):599-600. doi: 10.1007/s12603-012-0096-y. No abstract available.
- Background: PubMed 24999805Cesari M, Demougeot L, Boccalon H, Guyonnet S, Abellan Van Kan G, Vellas B, Andrieu S. A self-reported screening tool for detecting community-dwelling older persons with frailty syndrome in the absence of mobility disability: the FiND questionnaire. PLoS One. 2014 Jul 7;9(7):e101745. doi: 10.1371/journal.pone.0101745. eCollection 2014.
- Background: PubMed 27871235Morris JN, Howard EP, Steel KR. Development of the interRAI home care frailty scale. BMC Geriatr. 2016 Nov 21;16(1):188. doi: 10.1186/s12877-016-0364-5.
- Background: PubMed 24773077Sieliwonczyk E, Perkisas S, Vandewoude M. Frailty indexes, screening instruments and their application in Belgian primary care. Acta Clin Belg. 2014 Aug;69(4):233-9. doi: 10.1179/2295333714Y.0000000027. Epub 2014 Apr 29.
- Background: PubMed 29976541Zulfiqar AA. Identification of frailty by the use of the SEGAm scale (part A) in geriatrical consultation. Geriatr Psychol Neuropsychiatr Vieil. 2018 Sep 1;16(3):269-277. doi: 10.1684/pnv.2018.0740.
- Background: PubMed 28822918Oubaya N, Drame M, Novella JL, Quignard E, Cunin C, Jolly D, Mahmoudi R. Screening for frailty in community-dwelling elderly subjects: Predictive validity of the modified SEGA instrument. Arch Gerontol Geriatr. 2017 Nov;73:177-181. doi: 10.1016/j.archger.2017.07.026. Epub 2017 Aug 4.
- Background: PubMed 30335257Feck E, Zulfiqar AA. [Screening of frailty in family practice by the modified SEGA grid]. Rev Med Liege. 2018 Oct;73(10):513-518. French.
- Background: PubMed 27005336Tardieu E, Mahmoudi R, Novella JL, Oubaya N, Blanchard F, Jolly D, Drame M. [External validation of the short emergency geriatric assessment (SEGA) instrument on the SAFES cohort]. Geriatr Psychol Neuropsychiatr Vieil. 2016 Mar;14(1):49-55. doi: 10.1684/pnv.2016.0592. French.
- PLAN NATIONAL "Bien veillir" 2007-2009.Link provided by the sponsor.
- Fiche de synthèse sur le questionnaire HS - F1109.Link provided by the sponsor.
- Haute Autorité de Santé - Comment repérer la fragilité en soins ambulatoires ?Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Frailty screening for people over 65 living at home. in people with Frailty, run by Elsan at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 2 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: Date of the medical visit with the geriatrician.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04537039, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2024.