Optimisation of Falls Prevention After Low-energy Osteoporotic Fractures: Feasibility Study
- Conditions
- Osteoporotic Fractures
- Interventions
- Other: rehabilitation program
- Registration Number
- NCT03642808
- Lead Sponsor
- Fondation Hôpital Saint-Joseph
- Brief Summary
Within the Groupe Hospitalier Paris Saint-Joseph (GHPSJ), a reinforced medical care of osteoporosis ('Fracture Liaison service') was organized for osteoporotic fractured patients. The evaluation of benefits of this program through a randomized study showed an improvement in diagnostic tests performed (bone densitometry) and antiosteoporotic treatment initiated (OPTIPOST study, being published in BMJ). However, of 323 patients included, 91 presented a new fracture within 12 months. Among them, 40/126 patients (31.7%) were in the reinforced medical care arm. This result clearly demonstrates the need for a specific medical care program for patients with osteoporotic fracture falling regularly.
- Detailed Description
Only few studies for secondary prevention of falls have been conducted in France yet. This can be partly explained by the complexity of reeducation programs to implement and by organization issues. Moreover, to our knowledge, no study has demonstrated the benefit of such programs on secondary prevention of osteoporotic fractures, even though falls prevention is needed. Our objective is to demonstrate with a pilot study the feasibility of a falls secondary prevention program, based on a rheumatology (GHPSJ) and reeducation wards (Hôpital Sainte-Marie Paris : HSMP) collaboration. Considering the innovative nature of both this program and this collaboration, a feasibility study is preferable before conducting a larger multicentric study, evaluating locomoter benefits of this program in comparison with usual primary care.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 17
- Men and women (age ≥ 60 years)
- Francophone
- Hospitalized patient or who is consulted in rheumatology or indicated for bone densitometry in Groupe Hospitalier Paris Saint-Joseph, who are suffered a low-energy osteoporotic fracture in the last 12 months
- Patient with an acceptable handicap level definied by a Timed Up & Go test (TUG) <14 seconds
- Autonomous patient with instrumental activities of daily living score (4 items) = 0/4 and Activities of Daily Living score (6 items) ≥5.5/6
- Patient with medical insurance
- History of locomor specialized care for the falls prevention
- Cognitive impairment/diagnosed dementia or chronic neurological disorder, which doesn't permit the undertanding or a follow-up to a rehabilitation program
- Fall due to a neurovascular disease or acute cardiovascular
- Significant comorbidities which don't permit a locomotor rehabilitation care
- Refusal to participate in the study
- Refusal to follow the entire rehabilitation program
- Geographic remoteness which doesn't permit the movement to the rehabilitation center
- Contreindicated balneotherapy: incontinence, skin disease or cardiovascular disease
- Patient under guardianship or curatorship
- Patient deprived of liberty
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description rehabilitation program rehabilitation program * Duration of 8 weeks for a cycle of rehabilitation at the rate of two half-days per week * Two interventions per half-day: 30 minutes of education and 1h30 of rehabilitation: physiotherapist, psychomotricity, adapted physical activity
- Primary Outcome Measures
Name Time Method Satisfaction of health professionals with reinforced medical care: questionnaire. 2 months Satisfaction of health professionals with reinforced medical care: satisfaction questionnaire. Evaluation made for the end of the program of reeducation Sections A and B and D: Hôpital Sainte-Marie Paris staff, Sections C and D: Groupe Hospitalier Paris Saint Joseph staff 12 questions for the sections A-B-C-D with possible answer: degree of satisfaction (very satisfied/rather satisfied/ rather unhappy/ very dissatisfied)
A. Regarding the rehabilitation program B. Regarding patients C. Regarding the inclusion visit D: Concerning the link between the rheumatology department of the Groupe Hospitalier Paris Saint Joseph and the hospital day of Rehabilitation of the Hôpital Sainte-Marie Paris
E: Overall assessment: ree commentCompliance and satisfaction of patients with reinforced medical care 2 months compliance and satisfaction of patients with reinforced medical care: compliance questionnaire. Evaluation made for the end of the program of reeducation :
EVALUATION OF PATIENT ATTENDANCE (2 questions):
1. How many days did you participate in re-education sessions at the Hôpital Sainte-Marie Paris as part of the OPTICHUTE rehabilitation program?
2. Have you attended all the proposed rehabilitation sessions? (yes/no)
EVALUATION OF PATIENT SATISFACTION: possible answer: degree of satisfaction (very satisfied/overall Satisfied/overall dissatisfied/ very dissatisfied)
A: concerning the initial medical examination and the organization of your appointments : 2 questions B: concerning the progress of the reeducation sessions: 5 questions C: concerning the rehabilitation program more generally: 5 questions D: overall assessment - free comment
- Secondary Outcome Measures
Name Time Method Number of news falls 1 year Number of new falls within the year following the beginning of the program
Number of new osteoporotic fractures 1 year Number of new osteoporotic fractures within the year following the beginning of the program
Number of new hospitalizations 1 year Number of new hospitalizations within the year following the beginning of the program
Trial Locations
- Locations (1)
Groupe Hospitalier Paris Saint Joseph
🇫🇷Paris, Ile-de-France, France