Elderly Clinical Trial
— VIGI91Official title:
Evaluation of Falls Occurring at Home in People Over 75 Equipped or Non-equipped With a Precocious Detection Device. Prospective Interventional Study.
Verified date | April 2015 |
Source | Assistance Publique - Hôpitaux de Paris |
Contact | n/a |
Is FDA regulated | No |
Health authority | France: Ministry of Health |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 33 |
Est. completion date | August 2014 |
Est. primary completion date | December 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 76 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
France | Cochin Hospital | Paris |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique - Hôpitaux de Paris | Conseil Général de l'Essonne, Europ Assistance, Hôpital Privé Gériatrique Les Magnolias (HPGM), Réseau Hippocampes, SAMU de l'Essonne, SDIS de l'Essonne, Vigilio S.A. |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Death | The death 6 months after a recurrent fall | 6 months | No |
Secondary | Time between the fall and the arrival of emergency | The time between the fall and the arrival of emergency will be compared in both groups. | 13 months | No |
Secondary | Hospitalization | The rate of subjects hospitalized (with the duration of hospitalization) | 13 months | No |
Secondary | Follow up of patients | The rate of subjects still living at home or having left to be admitted in an institution (nursing home, retirement home...). | 13 months | No |
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