NCT04537039

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 30, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 3, 2020

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2022

Completed
Last Updated

January 2, 2024

Status Verified

December 1, 2023

Enrollment Period

2.2 years

First QC Date

July 30, 2020

Last Update Submit

December 27, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    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.

    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.

  • 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.

  • To evaluate the subjective feeling of the existence of frailty by home care services.

    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).

    Through study completion, an average of 2 years.

  • +1 more secondary outcomes

Study Arms (1)

All the participants.

OTHER

This study only includes 1 arm.

Diagnostic Test: Frailty screening for people over 65 living at home.

Interventions

The home care services will carry out the SEGA-A test.

All the participants.

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinique la chataigneraie

Clermont-Ferrand, France

Location

Related Publications (13)

  • 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.

    PMID: 22836700BACKGROUND
  • Vellas 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.

    PMID: 23933875BACKGROUND
  • Rolland 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.

    PMID: 22182814BACKGROUND
  • Borsch-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.

    PMID: 23778574BACKGROUND
  • Vellas 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.

    PMID: 22836699BACKGROUND
  • Cesari 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.

    PMID: 24999805BACKGROUND
  • Morris 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.

    PMID: 27871235BACKGROUND
  • Sieliwonczyk 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.

    PMID: 24773077BACKGROUND
  • Zulfiqar 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.

    PMID: 29976541BACKGROUND
  • Oubaya 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.

    PMID: 28822918BACKGROUND
  • Feck E, Zulfiqar AA. [Screening of frailty in family practice by the modified SEGA grid]. Rev Med Liege. 2018 Oct;73(10):513-518. French.

    PMID: 30335257BACKGROUND
  • Tardieu 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.

    PMID: 27005336BACKGROUND
  • Woo 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.

    PMID: 25732832BACKGROUND

Related Links

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 30, 2020

First Posted

September 3, 2020

Study Start

September 1, 2020

Primary Completion

November 1, 2022

Study Completion

November 1, 2022

Last Updated

January 2, 2024

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations