- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03737487
Effectiveness of the Montpellier Falls Clinic in Preventing InjuRiEs (EMPIRE)
Effectiveness of the Montpellier Falls Clinic in Preventing Injuries in Older High-risk Adults
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Montpellier, France, 34295
- UHMontpellier
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
1 day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants with injurious falls
Time Frame: 1 day
|
A fall is defined as an "unexpected event in which the participant comes to rest on the ground, floor, or other lower level
|
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
|
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
|
1 day
|
mobility :Mobility assessed using a questionnaire
Time Frame: 1 day
|
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
|
1 day
|
ADLs
Time Frame: 1 day
|
ADLs
|
1 day
|
satisfaction with the programme using a questionnaire
Time Frame: 1 day
|
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
|
1 day
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- RECHMPL18_0393
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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