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