Clinical and Medico-economic Evaluation of the Cohort "People at Risk of Falling" (PARC)

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.

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.

Study Overview

• Status: Completed
• Conditions: Fall Patients
• Intervention / Treatment: Other: Innovativ supported

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Bourgoin-Jallieu, France, 38300
    • Centre hospitalier Pierre Oudot
  • Grenoble, France, 38043
    • CHU Grenoble-Alpes
  • Voiron, France, 38500
    • Centre Hospitalier de Voiron

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Innovative supported; In addition to usual care, patients benefit from connected tools (telealarm, numeric communication diary...) and from a strong accompaniment with a referent person who help better the patient.	Other: Innovativ supported; addition of connected tools and stronger accompaniment to prevent falls
No Intervention: conventional supported; Patients benefit from usual care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
comparison of the number of falls according to the innovative or non-innovative care of frail elderly people	The outcome measure is the number of falls with hospitalization collected through administrative data from health facilities	6 months

Collaborators and Investigators

• Sponsor: University Hospital, Grenoble
• Investigators: Principal Investigator: Pascal COUTURIER, MD, CHU Grenoble Alpes

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Helpful Links

• Société française de gériatrie et gerontologie, HAS, recommandations de bonnes pratiques
• Repérage et maintien de l'autonomie des personnes agées fragiles

Study record dates

Study Major Dates

• Study Start (Actual): February 16, 2018
• Primary Completion (Actual): April 12, 2019
• Study Completion (Actual): October 12, 2019

Study Registration Dates

• First Submitted: February 28, 2018
• First Submitted That Met QC Criteria: May 22, 2018
• First Posted (Actual): June 4, 2018

Study Record Updates

• Last Update Posted (Actual): December 27, 2019
• Last Update Submitted That Met QC Criteria: December 26, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 38RC16.044

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No