FallsEMPIRENCT03737487
Effectiveness of the Montpellier Falls Clinic in Preventing InjuRiEs
An observational study of Falls, run by University Hospital, Montpellier at 1 site in France.
Trial summary
A falls prevention clinic opened in Montpellier (France) in 2015. The objective of the project is to evaluate whether the tailored multifactorial programme delivered in this real practice setting by a geriatrician, a podiatrist, a physiotherapist, and a occupational therapist would help prevent injuries in high-risk… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Falls
- What is being tested?
- Multidisciplinary fall risk and geriatric comprehensive assessment
- Type of treatment
- Surgery or procedure
- How many people
- 160 participants
- Where
- 1 siteFrance
- Study dates
- 1 Nov 2016to 1 Jun 2018
- Phase
- Observational
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: All patients aged 65 or older with a history in the previous year of recurrent falls, or of a fall associated with a balance, gait, or muscle strength problem referred to the Montpellier falls prevention clinic over a 11-month period
Who may be able to join
- All patients aged 65 or older with a history in the previous year of recurrent falls, or of a fall associated with a balance, gait, or muscle strength problem referred to the Montpellier falls prevention clinic
Who cannot join
- patients unable to walk 3 metres with or without an assistive device
- patients expected to live for less than 6 months based on the geriatricians' expert opinion
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of the Montpellier Falls Clinic in Preventing Injuries in Older High-risk Adults
A falls prevention clinic opened in Montpellier (France) in 2015. The objective of the project is to evaluate whether the tailored multifactorial programme delivered in this real practice setting by a geriatrician, a podiatrist, a physiotherapist, and a occupational therapist would help prevent injuries in high-risk older patients using a 6-month pre-post intervention analysis.
Read the detailed description
The Montpellier falls prevention clinic is a referral-based clinic specialized in the prevention of falls and fractures among patients aged 65+ (http://www.chu-montpellier.fr/fr/crepc/). The FPC that opened in 2015 is a member of the European Commission in its European Innovation Partnership on Active and Healthy Ageing (EIP on AHA) A2 action plan. The main mission of the clinic is to identify the underlying causes of the patients' falls, and to address modifiable risk factors in collaboration with family physicians in order to prevent injurious falls.
Based on a geriatric assessment performed by a geriatrician, a podologist, a occupational therapist, and a physiotherapist, the likely diagnoses and recommendations are notified in the medical report that is handed over to the patient or the caregiver for the patient's GP, along with the prescriptions, and sent also by mail to the GP. Recommendations remain under the GP's control with the possibility of another consultation if needed.
All patients admitted to the FPC are reassessed by phone at 3 months to register falls and injuries, and at 6 months to register falls and injuries, assess fear of falling, mobility and ability to perform activities of daily living, and satisfaction for the programme, and list proposed measures effectively applied.
- Conditions
- Falls
- Being tested
- Multidisciplinary fall risk and geriatric comprehensive assessment
- Keywords
- geriatric assessment, fear of falling, injuries
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multidisciplinary fall risk and geriatric comprehensive assessmentProcedure or surgery
- Complete blood count, serum electrolytes, C-Reactive Protein, transaminases and gamma-glutamyl transferase, thyroid-stimulating hormone, and 25OH vitamin D.
- Calculation of BMI
- A 40-min assessment of balance, walking speed, muscle strength, activity, and functional status by a physiotherapist
- A 40-min assessment by an occupational therapist, including a detailed questionnaire on social support, living situation and home environment, fear of falling, and cognitive function
- A 20-min assessment by a podiatrist including an examination of the patient's feet and footwear.
- A 60-min assessment by a geriatrician including assessment of circumstances of the previous fall(s), review of current medications and medical history, and an in-depth examination of the patient to detect possible contributors or risk factors for falling
- A 20-min review meeting with the 4 healthcare professionals in order to prioritize recommendations to be provided.
What is being measured
The primary outcome is the main question the study is designed to answer.
Serious falls
Falls with serious injuries are those that cause fractures, head injuries requiring admission to hospital, joint dislocations, sprains accompanied by reduced physical function, other non-specified serious joint injuries, and lacerations requiring sutures.Falls with moderate injuries are those that result in bruising, sprains, cuts, abrasions, or reduction in physical function for at least three days or in medical hel
Measured: 1 day
Secondary outcomes (5)
Number of Participants with injurious falls
A fall is defined as an "unexpected event in which the participant comes to rest on the ground, floor, or other lower level
Measured: 1 day
fear of falling: Fear of falling assessed with a questionnaire to determine the number of patients not concerned, a little concerned, quite concerned or very concerned with a fear of falling
Fear of falling assessed with a questionnaire to determine the number of patients not concerned, a little concerned, quite concerned or very concerned with a fear of falling
Measured: 1 day
mobility :Mobility assessed using a questionnaire
Mobility assessed using a questionnaire to determine the number of patients who, for both outside and inside displacements, do not walk, walk with a wheelchair, walk with a walker, walk with a stick, walk with a human help, or walk independently
Measured: 1 day
ADLs
ADLs
Measured: 1 day
satisfaction with the programme using a questionnaire
Satisfaction with the programme using a questionnaire to determine the number of patients very satisfied, somewhat satisfied, somewhat dissatisfied, or very satisfied for 6 parameters including the quality of the information provided, the suitability of recommendations, the duration of the visit, the competence of the team, and the welcoming conditions
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2018
- Study start1 Nov 2016
- Primary completion1 Nov 2017
- Study completion1 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FallsStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- hubert Blain, MD, PhD, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03737487
- Sponsor's protocol ID
- RECHMPL18_0393
- Acronym
- EMPIRE
- Status last verified
- Nov 2018
- First submitted
- 2 Nov 2018
- Last updated
- 9 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of the Montpellier Falls Clinic in Preventing Injuries in Older High-risk Adults
- ClinicalTrials.gov ID
- NCT03737487
- Acronym / sponsor ID
- EMPIRE / RECHMPL18_0393
- Conditions
- Falls
- Keywords
- geriatric assessment, fear of falling, injuries
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Nov 2016 (actual)
- Primary completion
- 1 Nov 2017 (actual)
- Study completion
- 1 Jun 2018 (actual)
- First posted
- 9 Nov 2018 (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.
A falls prevention clinic opened in Montpellier (France) in 2015. The objective of the project is to evaluate whether the tailored multifactorial programme delivered in this real practice setting by a geriatrician, a podiatrist, a physiotherapist, and a occupational therapist would help prevent injuries in high-risk older patients using a 6-month pre-post intervention analysis.
Detailed description
The Montpellier falls prevention clinic is a referral-based clinic specialized in the prevention of falls and fractures among patients aged 65+ (http://www.chu-montpellier.fr/fr/crepc/). The FPC that opened in 2015 is a member of the European Commission in its European Innovation Partnership on Active and Healthy Ageing (EIP on AHA) A2 action plan. The main mission of the clinic is to identify the underlying causes of the patients' falls, and to address modifiable risk factors in collaboration with family physicians in order to prevent injurious falls.
Based on a geriatric assessment performed by a geriatrician, a podologist, a occupational therapist, and a physiotherapist, the likely diagnoses and recommendations are notified in the medical report that is handed over to the patient or the caregiver for the patient's GP, along with the prescriptions, and sent also by mail to the GP. Recommendations remain under the GP's control with the possibility of another consultation if needed.
All patients admitted to the FPC are reassessed by phone at 3 months to register falls and injuries, and at 6 months to register falls and injuries, assess fear of falling, mobility and ability to perform activities of daily living, and satisfaction for the programme, and list proposed measures effectively applied.
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
- All patients aged 65 or older with a history in the previous year of recurrent falls, or of a fall associated with a balance, gait, or muscle strength problem referred to the Montpellier falls prevention clinic over a 11-month period
Key inclusion criteria (1 listed)
- All patients aged 65 or older with a history in the previous year of recurrent falls, or of a fall associated with a balance, gait, or muscle strength problem referred to the Montpellier falls prevention clinic
Key exclusion criteria (2 listed)
- patients unable to walk 3 metres with or without an assistive device
- patients expected to live for less than 6 months based on the geriatricians' expert opinion
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 |
|---|---|---|
| Multidisciplinary fall risk and geriatric comprehensive assessment* Complete blood count, serum electrolytes, C-Reactive Protein, transaminases and gamma-glutamyl transferase, thyroid-stimulating hormone, and 25OH vitamin D. * Calculation of BMI * A 40-min assessment of balance, walking speed, muscle strength, activity, and functional status by a physiotherapist * A 40-min assessment by an occupational therapist, including a detailed questionnaire on social support, living situation and home environment, fear of falling, and cognitive function * A 20-min assessment by a podiatrist including an examination of the patient's feet and footwear. * A 60-min assessment by a geriatrician including assessment of circumstances of the previous fall(s), review of current medications and medical history, and an in-depth examination of the patient to detect possible contributors or risk factors for falling * A 20-min review meeting with the 4 healthcare professionals in order to prioritize recommendations to be provided. | Procedure or surgery | – |
Primary outcome
Serious falls
Time frame: 1 day
Falls with serious injuries are those that cause fractures, head injuries requiring admission to hospital, joint dislocations, sprains accompanied by reduced physical function, other non-specified serious joint injuries, and lacerations requiring sutures.Falls with moderate injuries are those that result in bruising, sprains, cuts, abrasions, or reduction in physical function for at least three days or in medical hel
5 secondary outcomes
Number of Participants with injurious falls
Time frame: 1 day
fear of falling: Fear of falling assessed with a questionnaire to determine the number of patients not concerned, a little concerned, quite concerned or very concerned with a fear of falling
Time frame: 1 day
mobility :Mobility assessed using a questionnaire
Time frame: 1 day
ADLs
Time frame: 1 day
satisfaction with the programme using a questionnaire
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2018.
- Individual participant dataSharing planned: Undecided. NC
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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.
hubert Blain, MD, PhD principal investigator
University Hospital, Montpellier
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, run by University Hospital, Montpellier 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 1 inclusion and 2 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: finished, as of the sponsor's last update on 9 Nov 2018. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Serious falls (time frame: 1 day). 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 9 Nov 2018.