Frailty Clinical Trial
Official title:
Prospective, Multicentric Study, Aiming to Assess the Relevance of a Frailty Screening by Home Care Services
NCT number | NCT04537039 |
Other study ID # | FRAILTY |
Secondary ID | |
Status | Withdrawn |
Phase | N/A |
First received | |
Last updated | |
Start date | September 1, 2020 |
Est. completion date | November 2022 |
Verified date | December 2023 |
Source | Elsan |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | November 2022 |
Est. primary completion date | November 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 65 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
France | Clinique la chataigneraie | Clermont-Ferrand |
Lead Sponsor | Collaborator |
---|---|
Elsan |
France,
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
* Note: There are 13 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | |
Primary | 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 | 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. | Date of the visit of the home care services. | |
Secondary | 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. | Date of the visit of the home care services. | |
Secondary | 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. | Date of the visit of the home care services. | |
Secondary | 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. | Date of the visit of the home care services. | |
Secondary | 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. | Through study completion, an average of 2 years. | |
Secondary | 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). | Through study completion, an average of 2 years. |
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