Frail Elderly Subjects - Evaluation and Follow-Up (SAFES Cohort)
22. července 2016 aktualizováno: CHU de Reims
Frail Elderly Subjects: Inhospital Pathways and Adverse Outcome After Hospitalisation Via Emergency Department
This was a prospective multicenter cohort study of elderly people admitted to medical wards via emergency departments.
Subjects were followed up to 36 months.
It aimed to study the inhospital pathways and adverse geriatric outcomes.
In all, 1306 subjects were included : 85+/-5 years, and mainly women (65%).
Přehled studie
Postavení
Dokončeno
Podmínky
Intervence / Léčba
Detailní popis
The SAFES cohort was formed within a National Research Program (funded by the French Ministry of health) into the recruitment of emergency units in nine teaching hospitals.
All nine centres had a geriatric ward.
The inclusion of subjects ran from March 1st 2001 to January 17th 2002.
To be eligible, patients were to be 75 or over, to have been hospitalised in a medical ward in the same hospital as the emergency unit to which they were initially admitted.
Subjects were not eligible if hospitalisation was into intensive care or surgery, or if admission did not occur after admission to the emergency unit.
Every day in each centre, patients admitted to the emergency unit were registered.
From the list thus obtained, patients were selected by random draw stratified at two levels: in each week, 5 days were selected randomly, and for each of these days, two patients were chosen randomly.
Next, each patient was visited by a specialist in geriatrics familiar with the survey procedures.
In the course of this interview, patients were informed about the study, prior to signing the consent form.
If the clinical status and/or the cognitive status of the patient did not enable informed consent, the interviewer referred to the subject's representative.
Follow-up was by telephone interview after the 1st, 8th and 21st month and by face-to-face interviews after the 5th, 12th, 18th, and 24th month following the initial hospitalisation.
Several outcome have been studied.
Typ studie
Pozorovací
Zápis (Aktuální)
1306
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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Reims
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France, Reims, Francie, 51092
- Chu Reims
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
75 let a starší (Starší dospělý)
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Všechno
Metoda odběru vzorků
Ukázka pravděpodobnosti
Studijní populace
Patients were selected randomly from the emergency department.
Subjects were to 75 years or over, and admitted to a medical ward after emargency department stay.
Those who were admitted to surgery or intensive care units were excluded from the study
Popis
Inclusion Criteria:
- Age of 75 years or over
- Admitted to medical ward via emergency department
- Consent to participate
Exclusion Criteria:
- Not hospitalised after emergency department stay
- Admitted to surgery or intensive car unit
- Died before signing informed consent form
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
Intervence / Léčba |
|---|---|
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Frail elderly people
A group of elderly people hospitalised in medical wards via emergency department
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Časové okno |
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Mortality
Časové okno: up to 36 months
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up to 36 months
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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Obecné publikace
- 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.
- de Boissieu P, Mahmoudi R, Hentzien M, Toquet S, Novella JL, Blanchard F, Jolly D, Drame M. Predictors of Long-Term Mortality in Oldest Old Patients (90+) Hospitalized to Medical Wards via the Emergency Department: The SAFES Cohort. J Nutr Health Aging. 2015 Jun;19(6):702-7. doi: 10.1007/s12603-015-0515-y.
- Lang PO, Mahmoudi R, Novella JL, Tardieu E, Bertholon LA, Nazeyrollas P, Blanchard F, Jolly D, Drame M. Is obesity a marker of robustness in vulnerable hospitalized aged populations? Prospective, multicenter cohort study of 1 306 acutely ill patients. J Nutr Health Aging. 2014 Jan;18(1):66-74. doi: 10.1007/s12603-013-0352-9.
- Narbey D, Jolly D, Mahmoudi R, Trenque T, Blanchard F, Novella JL, Drame M. Relationship between anticholinergic drug use and one-year outcome among elderly people hospitalised in medical wards via emergency department: the SAFES cohort study. J Nutr Health Aging. 2013 Sep;17(9):766-71. doi: 10.1007/s12603-013-0349-4.
- Drame M, Lang PO, Novella JL, Narbey D, Mahmoudi R, Laniece I, Somme D, Gauvain JB, Heitz D, Voisin T, de Wazieres B, Gonthier R, Ankri J, Saint-Jean O, Jeandel C, Couturier P, Blanchard F, Jolly D. Six-month outcome of elderly people hospitalized via the emergency department: the SAFES cohort. Rev Epidemiol Sante Publique. 2012 Jun;60(3):189-96. doi: 10.1016/j.respe.2011.11.004. Epub 2012 May 16.
- Dhaussy G, Drame M, Jolly D, Mahmoudi R, Barbe C, Kanagaratnam L, Nazeyrollas P, Blanchard F, Novella JL; SAFES Group. Is health-related quality of life an independent prognostic factor for 12-month mortality and nursing home placement among elderly patients hospitalized via the emergency department? J Am Med Dir Assoc. 2012 Jun;13(5):453-8. doi: 10.1016/j.jamda.2011.10.002. Epub 2011 Nov 13.
- Drame M, Novella JL, Jolly D, Laniece I, Somme D, Heitz D, Gauvain JB, Voisin T, De Wazieres B, Gonthier R, Jeandel C, Couturier P, Saint-Jean O, Ankri J, Blanchard F, Lang PO. Rapid cognitive decline, one-year institutional admission and one-year mortality: analysis of the ability to predict and inter-tool agreement of four validated clinical frailty indexes in the SAFEs cohort. J Nutr Health Aging. 2011 Aug;15(8):699-705. doi: 10.1007/s12603-011-0164-8.
- Lang PO, Drame M, Mahmoudi R, Jolly D, Laniece I, Saint-Jean O, Somme D, Heitz D, Gauvain JB, Voisin T, de Wazieres B, Gonthier R, Jeandel C, Couturier P, Ankri J, Blanchard F, Novella JL. [Frailty: learnings from the SAFEs cohort study and future perspectives for the research]. Geriatr Psychol Neuropsychiatr Vieil. 2011 Jun;9(2):135-49. doi: 10.1684/pnv.2011.0279. French.
- Drame M, Fierobe F, Lang PO, Jolly D, Boyer F, Mahmoudi R, Somme D, Laniece I, Heitz D, Gauvain JB, Voisin T, De Wazieres B, Gonthier R, Ankri J, Saint-Jean O, Couturier P, Jeandel C, Blanchard F, Novella JL. Predictors of institution admission in the year following acute hospitalisation of elderly people. J Nutr Health Aging. 2011 May;15(5):399-403. doi: 10.1007/s12603-011-0004-x.
- Drame M, Lang PO, Jolly D, Narbey D, Mahmoudi R, Laniece I, Somme D, Gauvain JB, Heitz D, Voisin T, de Wazieres B, Gonthier R, Ankri J, Saint-Jean O, Jeandel C, Couturier P, Blanchard F, Novella JL. Nursing home admission in elderly subjects with dementia: predictive factors and future challenges. J Am Med Dir Assoc. 2012 Jan;13(1):83.e17-20. doi: 10.1016/j.jamda.2011.03.002. Epub 2011 Apr 13.
- Lang PO, Drame M, Jolly D, Novella JL, Blanchard F, Michel JP. [What do we learn from the SAFEs cohort to fit hospital care models for aged inpatient?]. Presse Med. 2010 Nov;39(11):1132-42. doi: 10.1016/j.lpm.2010.05.009. Epub 2010 Jul 1. French.
- Somme D, Lazarovici C, Drame M, Blanc P, Lang PO, Gauvain JB, Voisin T, Gonthier R, De Wazieres B, Jeandel C, Couturier P, Blanchard F, Saint-Jean O. The geriatric patient: use of acute geriatrics units in the emergency care of elderly patients in France. Arch Gerontol Geriatr. 2011 Jan-Feb;52(1):40-5. doi: 10.1016/j.archger.2010.01.018. Epub 2010 Mar 3.
- Lang PO, Zekry D, Michel JP, Drame M, Novella JL, Jolly D, Blanchard F. Early markers of prolonged hospital stay in demented inpatients: a multicentre and prospective study. J Nutr Health Aging. 2010 Feb;14(2):141-7. doi: 10.1007/s12603-009-0182-y.
- Drame M, Dia PA, Jolly D, Lang PO, Mahmoudi R, Schwebel G, Kack M, Debart A, Courtaigne B, Laniece I, Blanchard F, Novella JL. [Factors predictive of long-term mortality in patients aged 75 years or older hospitalized from the emergency department: the SAFES cohort]. Presse Med. 2009 Jul-Aug;38(7-8):1068-75. doi: 10.1016/j.lpm.2009.01.019. Epub 2009 Apr 18. French.
- Viatonou S, Drame M, Jolly D, Morrone I, Lang PO, Voisin T, Boyer FC, Schwebel G, Somme D, Blanchard F, Novella JL. Predictors of rapid cognitive decline among demented subjects aged 75 or more: ('Sujet Age Fragile--Evaluation et Suivi' Cohort-SAFES). Int J Geriatr Psychiatry. 2009 Jul;24(7):709-15. doi: 10.1002/gps.2183.
- Prudent M, Drame M, Jolly D, Trenque T, Parjoie R, Mahmoudi R, Lang PO, Somme D, Boyer F, Laniece I, Gauvain JB, Blanchard F, Novella JL. Potentially inappropriate use of psychotropic medications in hospitalized elderly patients in France: cross-sectional analysis of the prospective, multicentre SAFEs cohort. Drugs Aging. 2008;25(11):933-46. doi: 10.2165/0002512-200825110-00004.
- Drame M, Novella JL, Lang PO, Somme D, Jovenin N, Laniece I, Couturier P, Heitz D, Gauvain JB, Voisin T, De Wazieres B, Gonthier R, Ankri J, Jeandel C, Saint-Jean O, Blanchard F, Jolly D. Derivation and validation of a mortality-risk index from a cohort of frail elderly patients hospitalised in medical wards via emergencies: the SAFES study. Eur J Epidemiol. 2008;23(12):783-91. doi: 10.1007/s10654-008-9290-y. Epub 2008 Oct 21.
- Drame M, Jovenin N, Novella JL, Lang PO, Somme D, Laniece I, Voisin T, Blanc P, Couturier P, Gauvain JB, Blanchard F, Jolly D. Predicting early mortality among elderly patients hospitalised in medical wards via emergency department: the SAFES cohort study. J Nutr Health Aging. 2008 Oct;12(8):599-604. doi: 10.1007/BF02983207.
- Laniece I, Couturier P, Drame M, Gavazzi G, Lehman S, Jolly D, Voisin T, Lang PO, Jovenin N, Gauvain JB, Novella JL, Saint-Jean O, Blanchard F. Incidence and main factors associated with early unplanned hospital readmission among French medical inpatients aged 75 and over admitted through emergency units. Age Ageing. 2008 Jul;37(4):416-22. doi: 10.1093/ageing/afn093. Epub 2008 May 16.
- Lang PO, Meyer N, Heitz D, Drame M, Jovenin N, Ankri J, Somme D, Novella JL, Gauvain JB, Couturier P, Laniece I, Voisin T, de Wazieres B, Gonthier R, Jeandel C, Jolly D, Saint-Jean O, Blanchard F. Loss of independence in Katz's ADL ability in connection with an acute hospitalization: early clinical markers in French older people. Eur J Epidemiol. 2007;22(9):621-30. doi: 10.1007/s10654-007-9150-1. Epub 2007 Jul 25.
- Lang PO, Heitz D, Meyer N, Drame M, Jovenin N, Ankri J, Somme D, Novella JL, Gauvain JB, Colvez A, Couturier P, Laniece I, Voisin T, de Wazieres B, Gonthier R, Jeandel C, Jolly D, Saint-Jean O, Blanchard F. [Early indicators of prolonged hospitalization of the elderly: pilot study at Strasbourg University Hospital]. Presse Med. 2007 Mar;36(3 Pt 1):389-98. doi: 10.1016/j.lpm.2006.12.020. Epub 2007 Jan 17. French.
- Lang PO, Heitz D, Hedelin G, Drame M, Jovenin N, Ankri J, Somme D, Novella JL, Gauvain JB, Couturier P, Voisin T, De Waziere B, Gonthier R, Jeandel C, Jolly D, Saint-Jean O, Blanchard F. Early markers of prolonged hospital stays in older people: a prospective, multicenter study of 908 inpatients in French acute hospitals. J Am Geriatr Soc. 2006 Jul;54(7):1031-9. doi: 10.1111/j.1532-5415.2006.00767.x. Erratum In: J Am Geriatr Soc. 2006 Sep;54(9):1479-80.
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia
1. března 2001
Primární dokončení (Aktuální)
1. prosince 2005
Dokončení studie (Aktuální)
1. prosince 2005
Termíny zápisu do studia
První předloženo
13. července 2016
První předloženo, které splnilo kritéria kontroly kvality
13. července 2016
První zveřejněno (Odhad)
15. července 2016
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
25. července 2016
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
22. července 2016
Naposledy ověřeno
1. července 2016
Více informací
Termíny související s touto studií
Další identifikační čísla studie
- 44N98
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
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