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Evaluation of a Fall Detection Device in Isolated Elderly (VIGI91)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Vigilio S.A.
Hôpital Privé Gériatrique Les Magnolias (HPGM)
Conseil Général de l'Essonne
SDIS de l'Essonne
SAMU de l'Essonne
Europ Assistance
Réseau Hippocampes
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01422252
First received: August 22, 2011
Last updated: July 26, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention
Accidental Falls
Elderly
Device: Vigi'Fall®

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Evaluation of Falls Occurring at Home in People Over 75 Equipped or Non-equipped With a Precocious Detection Device. Prospective Interventional Study.

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Death [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    The death 6 months after a recurrent fall


Secondary Outcome Measures:
  • Time between the fall and the arrival of emergency [ Time Frame: 13 months ] [ Designated as safety issue: No ]
    The time between the fall and the arrival of emergency will be compared in both groups.

  • Hospitalization [ Time Frame: 13 months ] [ Designated as safety issue: No ]
    The rate of subjects hospitalized (with the duration of hospitalization)

  • Follow up of patients [ Time Frame: 13 months ] [ Designated as safety issue: No ]
    The rate of subjects still living at home or having left to be admitted in an institution (nursing home, retirement home...).


Enrollment: 33
Study Start Date: October 2011
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Persons equipped
Precocious fall detection device
Device: Vigi'Fall®
Precocious fall detection device
Other Name: Vigi'Fall®
No Intervention: Persons non-equipped
No fall detection device

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   76 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Person over 75 living at home alone in ESSONNE (France) and having fallen at least one time during the 3 months preceding the inclusion in the study.
  • Person having signed a free and enlightened consent

Exclusion Criteria:

  • Person living in institution (nursing home, retirement home...)
  • Person under 75
  • Person with severe cognitive impairment (MMS < 15)
  • Person under protection as incapable (guardianship or trusteeship)
  • Person not affiliated to a social insurance
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01422252

Locations
France
Cochin Hospital
Paris, France, 75014
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Vigilio S.A.
Hôpital Privé Gériatrique Les Magnolias (HPGM)
Conseil Général de l'Essonne
SDIS de l'Essonne
SAMU de l'Essonne
Europ Assistance
Réseau Hippocampes
Investigators
Principal Investigator: Yann-Erick Claessens, MD, PhD Cochin Hospital, Paris
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01422252     History of Changes
Other Study ID Numbers: P100202
Study First Received: August 22, 2011
Last Updated: July 26, 2013
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Falls Elderly persons
Isolated At risk for falls
Fall detection device
Precocious detection Vigi'Fall®

ClinicalTrials.gov processed this record on November 20, 2014