Clinical trial NCT03545529: Clinical and Medico-economic Evaluation of the Cohort "People at Risk of Falling"
Official title: Medico-economic Assessment of a "IsereADOM" Package of Services Versus Conventional Monitoring in the Care of a Population of Frail Elderly People With Loss of Autonomy.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fall Patients
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2018-06-04
Enrollment: 14
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The goal of this study is to evaluate the effectiveness of the IsereADOM service package compared to conventional follow-up on the risk of recurrence of falls at 6 months in frail elderly subjects.

There is a medico-economic goal too, is to conduct a cost-utility analysis of the IsereADOM service bundle compared to conventional 6-month follow-up from the community perspective in the cheat population at risk of re-offending.


Eligibility criteria: Inclusion Criteria :

* Patient falling at least 2 times in the year preceding the inclusion, one of them has been reported or consulted by a health care service ;
* Patient fragile and loss of autonomy: level of dependence with GIR 3, 4 and 5 ;
* Patient domiciled in the department of Isère ;
* Patient who can be followed regularly for 6 months ;
* Patient benefiting from an assistance plan : APA, PAP, CARSAT ;
* Patient affiliated with social security or beneficiary of such a scheme ;
* Patient able to read, write and understand French ;
* Patient having signed informed consent to participate.

Exclusion Criteria :

* Patient without professional or family carer of proximity ;
* Patient with moderate to severe cognitive impairment defined by MMS \<23 ;
* Patient residing in a nursing home or institution for dependent person ;
* Persons referred to in Articles L1121-5 to L1121-8 of the CSP (corresponds to all persons protected: pregnant woman, parturient, mother who is breastfeeding, person deprived of liberty by judicial or administrative decision, person subject of a legal protection measure).

Primary outcomes:
measure: comparison of the number of falls according to the innovative or non-innovative care of frail elderly people
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bourgoin-Jallieu
country: France
facility: Centre Hospitalier Pierre Oudot
city: Grenoble
country: France
facility: CHU Grenoble-Alpes
city: Voiron
country: France
facility: Centre Hospitalier de Voiron
Study officials:
affiliation: CHU Grenoble Alpes
name: Pascal COUTURIER, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gillespie LD, Robertson MC, Gillespie WJ, Sherrington C, Gates S, Clemson LM, Lamb SE. Interventions for preventing falls in older people living in the community. Cochrane Database Syst Rev. 2012 Sep 12;2012(9):CD007146. doi: 10.1002/14651858.CD007146.pub3.
citation: Moyer VA; U.S. Preventive Services Task Force. Prevention of falls in community-dwelling older adults: U.S. Preventive Services Task Force recommendation statement. Ann Intern Med. 2012 Aug 7;157(3):197-204. doi: 10.7326/0003-4819-157-3-201208070-00462.
citation: Gates S, Smith LA, Fisher JD, Lamb SE. Systematic review of accuracy of screening instruments for predicting fall risk among independently living older adults. J Rehabil Res Dev. 2008;45(8):1105-16.
citation: Payen JF, Chanques G, Mantz J, Hercule C, Auriant I, Leguillou JL, Binhas M, Genty C, Rolland C, Bosson JL. Current practices in sedation and analgesia for mechanically ventilated critically ill patients: a prospective multicenter patient-based study. Anesthesiology. 2007 Apr;106(4):687-95; quiz 891-2. doi: 10.1097/01.anes.0000264747.09017.da.
citation: Manca A, Hawkins N, Sculpher MJ. Estimating mean QALYs in trial-based cost-effectiveness analysis: the importance of controlling for baseline utility. Health Econ. 2005 May;14(5):487-96. doi: 10.1002/hec.944.