NCT03545529

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2018

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 16, 2018

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

February 28, 2018

Completed
3 months until next milestone

First Posted

Study publicly available on registry

June 4, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 12, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 12, 2019

Completed
Last Updated

December 27, 2019

Status Verified

December 1, 2019

Enrollment Period

1.2 years

First QC Date

February 28, 2018

Last Update Submit

December 26, 2019

Conditions

Fall Patients

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Innovative supported

EXPERIMENTAL

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

conventional supported

NO INTERVENTION

Patients benefit from usual care

Interventions

Innovativ supportedOTHER

addition of connected tools and stronger accompaniment to prevent falls

Innovative supported

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Centre Hospitalier Pierre Oudot

Bourgoin, 38300, France

Location

CHU Grenoble-Alpes

Grenoble, 38043, France

Location

Centre Hospitalier de Voiron

Voiron, 38500, France

Location

Related Publications (5)

  • 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.

    PMID: 22972103BACKGROUND

  • 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.

    PMID: 22868837BACKGROUND

  • 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.

    PMID: 19235113BACKGROUND

  • 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.

    PMID: 17413906BACKGROUND

  • 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.

    PMID: 15497198BACKGROUND

Related Links

Study Officials

  • Pascal COUTURIER, MD

    CHU Grenoble Alpes

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 28, 2018

First Posted

June 4, 2018

Study Start

February 16, 2018

Primary Completion

April 12, 2019

Study Completion

October 12, 2019

Last Updated

December 27, 2019

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share

Locations

FR(3)