Effectiveness of the Montpellier Falls Clinic in Preventing InjuRiEs

Falls Clinical Trial

— EMPIRE  

Official title:

Effectiveness of the Montpellier Falls Clinic in Preventing Injuries in Older High-risk Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03737487
• Other study ID #: RECHMPL18_0393
• Status: Completed
• Start date: November 1, 2016
• Est. completion date: June 1, 2018

Study information

• Verified date: November 2018
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 older patients using a 6-month pre-post intervention analysis.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: June 1, 2018
• Est. primary completion date: November 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Falls

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
France	Uhmontpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	1 day
Secondary	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	1 day
Secondary	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	1 day
Secondary	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	1 day
Secondary	ADLs	ADLs	1 day
Secondary	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	1 day