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

Detailed Description:

Objectives of the study:

Principal objective : 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. Prospective interventional study.

Secondary objective : To establish a relation between the alert emitted by the device, the time separating the fall from the arrival at hospital and the potential MORBI-mortality To describe the sequences of intervention of the different operators Methodology :Multicenter, prospective, cohort, interventional study. Pattern of the study : The study will comprehend 2 visits to be realized in a 10-month interval.

Visits:

  1. Randomization, inclusion and selection visit(Visit 1): The inclusion of the subject will be effective once the enlightened consent signed, after check of the inclusion criteria. Inclusion and standardized questioning will be realized by the medical evaluators. The data will be obtained by questioning the subject and if need be of relatives and GP. The questioning will be carried out with a questionnaire on independent card comprising the frailty elements. Independently, a follow-up will be operated at home by a nurse of HPGM Les Magnolias hospital for the maintenance of the adhesive patch to be changed regularly nearly every 10 days in the persons equipped, the study plans the installation of Vigi'Fall® device as the only peculiar measure during the coverage. At the conclusion of that first report, the whole questionnaires will be picked up again by a participant in charge of completing the potential missing data. Via this colligation of missing data, the exhaustiveness of the data will be automatically checked.
  2. End of study visit (Visit 2): 10 months 10 months after the installation of Vigi'Fall® device, a contact will be established with the subject and if need be relatives and GP to be informed of the evolution but as well the appearance of potential falls with their characteristics.

    • Relation between alert, intervention time and evolution : Theses relations will be investigated with the most possible accuracy. The standardized questioning will be completed by an investigator up to a maximal exhaustiveness.
    • Description of the sequences of intervention:These sequences will be evaluated via a simple and standardized questionnaire.
    • Expected results, perspectives and scientific data: To quantify with accuracy the evolution in persons over 75 equipped with a precocious detection device after a fall occurring at home in comparison with a witness population non equipped. To establish a relation between the alert emitted by the device, the time separating the fall from the arrival at hospital and the potential MORBI-mortality. To describe with the most possible accuracy the time sequences of the different operators To quantify the rate of subjects hospitalized (with the duration of hospitalization), of subjects still living at home or having left to be admitted in institution (nursing home, retirement home...) in the different groups. The information hence obtained will enable a better knowledge of the tools for detection and precocious alert in falls of the elderly.
    • Direct benefit for geriatricians, sanitary and care professionals and emergency physicians:

Change in practices :Prevision of subjects likely to benefit of a precocious detection device. Development of prevention in hospital geriatric departments, geriatric care networks, emergency departments and local services for the elderly and disabled (SDPAH).

Education : Sensitize the medical, paramedical and social teams to the usefulness of precocious detection devices in elderly subjects at risk for falls.

  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
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 April 16, 2014