Effectiveness of the Montpellier Falls Clinic in Preventing InjuRiEs (EMPIRE)

November 8, 2018 updated by: University Hospital, Montpellier

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.

Study Overview

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

Observational

Enrollment (Actual)

160

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Montpellier, France, 34295
        • UHMontpellier

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2016

Primary Completion (Actual)

November 1, 2017

Study Completion (Actual)

June 1, 2018

Study Registration Dates

First Submitted

November 2, 2018

First Submitted That Met QC Criteria

November 8, 2018

First Posted (Actual)

November 9, 2018

Study Record Updates

Last Update Posted (Actual)

November 9, 2018

Last Update Submitted That Met QC Criteria

November 8, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • RECHMPL18_0393

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

NC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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