Falls in the ElderlyPREMOBNCT05281835
Follow-up of Elderly Subjects With Falls Recruited in the Geriatric Departments of Several French Hospitals
An observational study of Falls in the Elderly, run by University Hospital, Lille at 1 site in France.
Trial summary
Falls are the leading cause of accidental death among the elderly, with nearly 8,000 deaths per year in France, including more than 950 deaths on average per year in the Northwest interregion between 2006 and 2013. The incidence of falls increases with age. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Falls in the Elderly
- How many people
- 1,000 participants
- Where
- 1 siteFrance
- Study dates
- 16 Jun 2022to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Elderly patients admitted at a day hospital for multidisciplinary falls assessment in one of the 12 french geriatric department participating in the study
Who may be able to join
- Male or female, 65 years of age or older
- Patients admitted at a day hospital for multidisciplinary falls assessment in one of the 12 geriatric department participating in the study
- Patient or, if applicable, his or her trusted person or guardian, having given his or her oral non-opposition
- Patient affiliated to a social health insurance scheme (beneficiaries or beneficiaries' dependents)
Who cannot join
- Expressed objection to the collection of data by the subject, his or her guardian, curator, trusted person or family member.
- Admission at the day hospital for multidisciplinary falls assessment is not indicated (despite the referral of the patient and the realization of the initial consultation).
- Refusal to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Falls are the leading cause of accidental death among the elderly, with nearly 8,000 deaths per year in France, including more than 950 deaths on average per year in the Northwest interregion between 2006 and 2013. The incidence of falls increases with age. Falls are often the consequence of multiple factors: extrinsic and intrinsic. The WHO classifies these risk factors into 4 groups: environmental, socio-economic, behavioral and biological.
The best way to act to reduce falls is to identify the risk and severity factors (risk of fracture, risk of loss of autonomy, risk of death) in order to correct those that are modifiable.
Read more
On a national scale, the prevention of falls has been considered for many years as a major issue in health prevention [INPES 2005]. The management of elderly patients who fall has been the subject of recommendations for good practice by the French National Authority for Health (HAS) in 2009. These recommendations include the need to look for signs of geriatric severity of falls.
The SNDS National System of healthcare data brings together and links the main national health databases in France. Linking data from the PMSI (Programme de Médicalisation des Systèmes d'Information) and the National Inter-regime Information System of the French National Health Insurance with data from death certificates via the SNDS opens up unique perspectives for improving the quality of follow-up of these patients. Crossing data from the Fall assessment clinic (clinical data) and SNDS data will allow data completeness and will improve our knowledge of the care consumption of elderly fallers. In particular, we wish to determine the risk factors for unplanned hospitalizations of patients with falls.
This project aims to set up a common multicenter cohort of patients assessed during the day hospital for multidisciplinary fall assessment in 12 geriatric services: the university hospitals of Lille, Amiens-Picardie, Rouen, Caen, Tours, Strasbourg, Angers, Dijon, the GHICL and the hospitals of St Quentin, Valenciennes and Beauvais Data collection is currently being harmonized in all participating clinical departments. The databases of the SNDS and that of the fall day hospital assessment will be crossed. This will allow us to improve our knowledge of the follow-up of elderly fallers, the impact of risk factors (clinical, psychosocial, organizational, etc.) and their interactions, the effectiveness of specific management on the occurrence of falls, serious falls as well as the use of care. 1,000 elderly patients admitted in 12 French geriatric departements for a fall assessment will participate in the study.
- Conditions
- Falls in the Elderly
- Keywords
- Elderly, Fallers, Falls, Risk factors, Cohort, National Health Data System
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of the first unplanned hospitalization within 1 year after the day hospital for multidisciplinary falls assessment
Measured: 1 year of follow up
Secondary outcomes (5)
Time between initial consultation (HDJ fall) and 1st unscheduled hospitalization occurring within 12 months of follow-up (dependent variable) and potential predictive factors
Time between initial consultation (HDJ fall) and 1st unscheduled hospitalization occurring within 12 months of follow-up (dependent variable) and potential predictive factors (independent variables): behavioral, environmental, medical-biological and socioeconomic factors.
Measured: within 12 months
Number of unplanned hospitalizations during the 12 months of follow-up or until the patient's death (expressed as number of hospitalizations per 100 patient years).
Measured: within 12 months
Time from initial consultation (HDJ fall) to occurrence of death within 12 months of follow-up.
Measured: within 12 months
Time between the initial consultation (HDJ fall) and the first hospitalization for fracture during the 12 months of follow-up.
Measured: within 12 months
Time from initial consultation (HDJ fall) to occurrence of 1st unplanned hospitalization or death within 12 months of follow-up.
Measured: within 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2022
- Study start16 Jun 2022
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Falls in the ElderlyStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- François Puissieux, MD,PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05281835
- Sponsor's protocol ID
- 2020_90
- Other IDs
- 2021-A00582-39
- Acronym
- PREMOB
- Status last verified
- Dec 2025
- First submitted
- 7 Mar 2022
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Follow-up of Elderly Subjects With Falls Recruited in the Geriatric Departments of Several French Hospitals
- ClinicalTrials.gov ID
- NCT05281835
- Acronym / sponsor ID
- PREMOB / 2020_90
- Conditions
- Falls in the Elderly
- Keywords
- Elderly, Fallers, Falls, Risk factors, Cohort, National Health Data System
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 16 Jun 2022 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 16 Mar 2022 (actual)
- 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.
Falls are the leading cause of accidental death among the elderly, with nearly 8,000 deaths per year in France, including more than 950 deaths on average per year in the Northwest interregion between 2006 and 2013. The incidence of falls increases with age. Falls are often the consequence of multiple factors: extrinsic and intrinsic. The WHO classifies these risk factors into 4 groups: environmental, socio-economic, behavioral and biological.
The best way to act to reduce falls is to identify the risk and severity factors (risk of fracture, risk of loss of autonomy, risk of death) in order to correct those that are modifiable.
On a national scale, the prevention of falls has been considered for many years as a major issue in health prevention [INPES 2005]. The management of elderly patients who fall has been the subject of recommendations for good practice by the French National Authority for Health (HAS) in 2009. These recommendations include the need to look for signs of geriatric severity of falls.
The SNDS National System of healthcare data brings together and links the main national health databases in France. Linking data from the PMSI (Programme de Médicalisation des Systèmes d'Information) and the National Inter-regime Information System of the French National Health Insurance with data from death certificates via the SNDS opens up unique perspectives for improving the quality of follow-up of these patients. Crossing data from the Fall assessment clinic (clinical data) and SNDS data will allow data completeness and will improve our knowledge of the care consumption of elderly fallers. In particular, we wish to determine the risk factors for unplanned hospitalizations of patients with falls.
This project aims to set up a common multicenter cohort of patients assessed during the day hospital for multidisciplinary fall assessment in 12 geriatric services: the university hospitals of Lille, Amiens-Picardie, Rouen, Caen, Tours, Strasbourg, Angers, Dijon, the GHICL and the hospitals of St Quentin, Valenciennes and Beauvais Data collection is currently being harmonized in all participating clinical departments. The databases of the SNDS and that of the fall day hospital assessment will be crossed. This will allow us to improve our knowledge of the follow-up of elderly fallers, the impact of risk factors (clinical, psychosocial, organizational, etc.) and their interactions, the effectiveness of specific management on the occurrence of falls, serious falls as well as the use of care. 1,000 elderly patients admitted in 12 French geriatric departements for a fall assessment will participate in the study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Elderly patients admitted at a day hospital for multidisciplinary falls assessment in one of the 12 french geriatric department participating in the study
Key inclusion criteria (4 listed)
- Male or female, 65 years of age or older
- Patients admitted at a day hospital for multidisciplinary falls assessment in one of the 12 geriatric department participating in the study
- Patient or, if applicable, his or her trusted person or guardian, having given his or her oral non-opposition
- Patient affiliated to a social health insurance scheme (beneficiaries or beneficiaries' dependents)
Key exclusion criteria (3 listed)
- Expressed objection to the collection of data by the subject, his or her guardian, curator, trusted person or family member.
- Admission at the day hospital for multidisciplinary falls assessment is not indicated (despite the referral of the patient and the realization of the initial consultation).
- Refusal to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of the first unplanned hospitalization within 1 year after the day hospital for multidisciplinary falls assessment
Time frame: 1 year of follow up
5 secondary outcomes
Time between initial consultation (HDJ fall) and 1st unscheduled hospitalization occurring within 12 months of follow-up (dependent variable) and potential predictive factors
Time frame: within 12 months
Number of unplanned hospitalizations during the 12 months of follow-up or until the patient's death (expressed as number of hospitalizations per 100 patient years).
Time frame: within 12 months
Time from initial consultation (HDJ fall) to occurrence of death within 12 months of follow-up.
Time frame: within 12 months
Time between the initial consultation (HDJ fall) and the first hospitalization for fracture during the 12 months of follow-up.
Time frame: within 12 months
Time from initial consultation (HDJ fall) to occurrence of 1st unplanned hospitalization or death within 12 months of follow-up.
Time frame: within 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
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Effects of a Community-based Multicomponent Physical Exercise Program on Physical Function, Frailty, and Sarcopenia in Older Adults From the Municipality of Santoña: a Quasi-experimental Study.
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Whole-Body Point-of-Care Ultrasound in Older Adults Presenting to the Emergency Department After a Fall
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Turkish Adaptation of the Multidimensional Falls Efficacy Scale in Older Adults
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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.
François Puissieux, MD,PhD principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Falls in the Elderly, run by University Hospital, Lille 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 4 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 12 May 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Incidence of the first unplanned hospitalization within 1 year after the day hospital for multidisciplinary falls assessment (time frame: 1 year of follow up). 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 12 May 2026.