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OpenTrials
Completed

NCT Number: NCT03545529

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

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.

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Key information

Conditions

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier Pierre Oudot, Bourgoin, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Innovativ supported

Other

addition of connected tools and stronger accompaniment to prevent falls

Primary outcomes

  1. comparison of the number of falls according to the innovative or non-innovative care of frail elderly people

    Time frame: 6 months

    The outcome measure is the number of falls with hospitalization collected through administrative data from health facilities

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Registry information

Official study 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.

Acronym: PARC

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jun 4, 2018
Registry last updated
Dec 27, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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