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

Fall Patients Clinical Trial

— PARC  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03545529
• Other study ID #: 38RC16.044
• Status: Completed
• Phase: N/A
• Start date: February 16, 2018
• Est. completion date: October 12, 2019

Study information

• Verified date: December 2019
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: October 12, 2019
• Est. primary completion date: April 12, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Fall Patients

Intervention

Other:
• Innovativ supported
addition of connected tools and stronger accompaniment to prevent falls

Locations

Country	Name	City	State
France	Centre Hospitalier Pierre Oudot	Bourgoin-Jallieu
France	CHU Grenoble-Alpes	Grenoble
France	Centre Hospitalier de Voiron	Voiron

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

References & Publications (5)

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. Review. — View 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;(9):CD007146. doi: 10.1002/14651858.CD007146.pub3. Review. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   Institut nationnal de prévention et d'éducation pour la santé. Prévention des chutes chez la personne agée à domicile
•   Repérage et maintien de l'autonomie des personnes agées fragiles
•   Société française de gériatrie et gerontologie, HAS, recommandations de bonnes pratiques