Accidental FallsVIGI91NCT01422252
Evaluation of a Fall Detection Device in Isolated Elderly
A study testing Vigi'Fall® in people with Accidental Falls and Elderly, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 76 years and older
- Conditions the study is for
- Accidental Falls, Elderly
- What is being tested?
- Vigi'Fall®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2011to Aug 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 76 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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:
- 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.
- 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.
- Conditions
- Accidental Falls, Elderly
- Being tested
- Vigi'Fall®
- Keywords
- Falls Elderly persons, Isolated At risk for falls, Fall detection device, Precocious detection Vigi'Fall®
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vigi'Fall®Device
Precocious fall detection device
| Study group | Role | What they receive |
|---|---|---|
| Persons equipped | Experimental | Precocious fall detection device Receives: Device: Vigi'Fall® |
| Persons non-equipped | No intervention | No fall detection device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Death
The death 6 months after a recurrent fall
Measured: 6 months
Secondary outcomes (3)
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.
Measured: 13 months
Hospitalization
The rate of subjects hospitalized (with the duration of hospitalization)
Measured: 13 months
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...).
Measured: 13 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2011 (estimated)
- Study startOct 2011
- Primary completionDec 2013
- Study completionAug 2014
Why it stopped: no more inclusions
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Accidental FallsStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- 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, URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Yann-Erick Claessens, MD, PhD, Principal investigator, Hôpital Cochin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01422252
- Sponsor's protocol ID
- P100202
- Acronym
- VIGI91
- Status last verified
- Dec 2025
- First submitted
- 22 Aug 2011
- Last updated
- 11 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Falls Occurring at Home in People Over 75 Equipped or Non-equipped With a Precocious Detection Device. Prospective Interventional Study.
- ClinicalTrials.gov ID
- NCT01422252
- Acronym / sponsor ID
- VIGI91 / P100202
- Conditions
- Accidental Falls, Elderly
- Keywords
- Falls Elderly persons, Isolated At risk for falls, Fall detection device, Precocious detection Vigi'Fall®
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: no more inclusions
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- 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, URC-CIC Paris Descartes Necker Cochin
- Study start
- Oct 2011
- Primary completion
- Dec 2013 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 23 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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.
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Persons equipped | Experimental | Device: Vigi'Fall®Precocious fall detection device |
| Persons non-equipped | No intervention | –No fall detection device |
Who may qualify
- Ages
- 76 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vigi'Fall®Precocious fall detection device | Device | Persons equipped |
Primary outcome
Death
Time frame: 6 months
The death 6 months after a recurrent fall
3 secondary outcomes
Time between the fall and the arrival of emergency
Time frame: 13 months
Hospitalization
Time frame: 13 months
Follow up of patients
Time frame: 13 months
Results and safety
The study was stopped early (reason given: no more inclusions). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yann-Erick Claessens, MD, PhD principal investigator
Hôpital Cochin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vigi'Fall® in people with Accidental Falls and Elderly, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: no more inclusions). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Death (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2025; AzTrials last refreshed its copy on 28 Oct 2026.