NCT01422252

Brief 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.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

First Submitted

Initial submission to the registry

August 22, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 23, 2011

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2011

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

December 11, 2025

Status Verified

December 1, 2025

Enrollment Period

2.2 years

First QC Date

August 22, 2011

Last Update Submit

December 4, 2025

Conditions

Accidental FallsElderly

Keywords

Falls Elderly personsIsolated At risk for fallsFall detection devicePrecocious detection Vigi'Fall®

Outcome Measures

Primary Outcomes (1)

  • Death

    The death 6 months after a recurrent fall

    6 months

Secondary Outcomes (3)

  • Time between the fall and the arrival of emergency

    13 months

  • Hospitalization

    13 months

  • Follow up of patients

    13 months

Study Arms (2)

Persons equipped

EXPERIMENTAL

Precocious fall detection device

Device: Vigi'Fall®

Persons non-equipped

NO INTERVENTION

No fall detection device

Interventions

Vigi'Fall®DEVICE

Precocious fall detection device

Persons equipped

Eligibility Criteria

Age76 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Person having signed a free and enlightened consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cochin Hospital

Paris, 75014, France

Location

Study Officials

  • Yann-Erick Claessens, MD, PhD

    Hôpital Cochin

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

August 22, 2011

First Posted

August 23, 2011

Study Start

October 1, 2011

Primary Completion

December 1, 2013

Study Completion

August 1, 2014

Last Updated

December 11, 2025

Record last verified: 2025-12

Locations

FR(1)