Evaluation of a Fall Detection Device in Isolated Elderly

NCT01422252 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2025-12-11

No results posted yet for this study

Summary

The objective of this study is to evaluate the evolution 6 months after a fall occurring at home in people over 75 equipped or non-equipped with a precocious detection device. The possibility to establish a relation between the alert emitted by the device, the time separating the fall from the arrival at hospital and the potential consequences for the persons will be analyzed with the greatest accuracy. Besides, the sequences of intervention of the different operators will be described with precision. 200 persons living at home in the ESSONNE(France)and having fallen at least one time during the previous 3 months will be included in the study and two groups of 100 will be constituted randomly after having signed a written consent. Of the 2 groups, one will be constituted with persons equipped with a precocious fall detection device named Vigi'Fall® , the second being non-equipped. After a first visit checking that the inclusion criteria are abide by and the installation of the device in the persons designated randomly for being equipped, a second visit will be carried out after 10 months in order to know the evolution, i.e. if the persons are still alive, living at home or having left for admission in an institution (hospital, nursing home, retirement home...). By a detailed comparison between the 2 groups, it will be possible to evaluate the potential interest of having been equipped or non-equipped with a precocious fall detection device. Hence, a change in practices may lead to a prevision of elderly persons likely to benefit of a precocious detection device and to the development of prevention in hospital geriatric departments, geriatric care networks, emergency departments and local services for the elderly and disabled. Another possible gain of the study is to sensitize the medical, paramedical and social teams to the usefulness of precocious detection devices in elderly subjects at risk for falls.

Conditions

  • Accidental Falls
  • Elderly

Interventions

DEVICE

Vigi'Fall®

Precocious fall detection device

Sponsors & Collaborators

  • Vigilio S.A.

    collaborator UNKNOWN
  • Hôpital Privé Gériatrique Les Magnolias (HPGM)

    collaborator UNKNOWN
  • Conseil Général de l'Essonne

    collaborator UNKNOWN
  • SDIS de l'Essonne

    collaborator UNKNOWN
  • SAMU de l'Essonne

    collaborator UNKNOWN
  • Europ Assistance

    collaborator UNKNOWN
  • Réseau Hippocampes

    collaborator UNKNOWN
  • URC-CIC Paris Descartes Necker Cochin

    collaborator OTHER
  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Yann-Erick Claessens, MD, PhD · Hôpital Cochin

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
76 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2013-12-31
Completion
2014-08-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01422252 on ClinicalTrials.gov