Reduction of Falls in the Elderly - Parkinson's Disease

Study Overview
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Brief Summary
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The REFINE-PD study is a controlled trial embedded within a larger cluster controlled study (the IMPACT study). The study aims to investigate the efficacy of a multifactorial falls prevention program for patients with Parkinson's Disease (PD). This program contains PD-specific elements (e.g., optimizing dopaminergic therapy), plus a generic falls prevention program. The intervention will be tailored to each individual's specific risk profile for falls, as identified during detailed baseline examination.

Detailed Description
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Falls and postural instability are common complications of advanced Parkinson's Disease (PD). Falls in PD often have devastating consequences, leading to a poor overall prognosis. In addition, falls in PD are associated with substantial medical expenses due to treatment of injuries and nursing home admission. The risk of falls in older PD patients is aggravated by generic age-related factors, such as sedative medication or poor vision. Observations on elderly persons without PD suggest that a multifactorial prevention program might be more effective. We propose to investigate the effectiveness of a multifactorial prevention program aimed at the prevention of falls in PD, which is based on disease-specific treatment strategies with demonstrated efficacy in PD, as well as prevention strategies with proven effectiveness for the general elderly population. In this study an individualised multifactorial program aimed at the prevention of falls in PD containing PD-specific elements and a generic falls prevention program will be compared to usual care.

Official Title
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Reduction of Falls in the Elderly - Parkinson's Disease

Conditions
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Parkinson's Disease

Intervention / Treatment
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* Other: Multifactorial fall prevention program
* Other: Usual care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with idiopathic Parkinson's Disease, diagnosed according to the Brain Bank criteria of the UK Parkinson's Society Regular control by the neurologist Living independently in the community Able to complete the trial questionnaires An increased risk for falling, defined as: at least one fall in the preceding 12 months OR recurrent (monthly) near falls in the preceding 12 months OR fear of falling OR (iv) avoidance of activities due to fear of falling OR a combination of these findings Exclusion Criteria: Atypical parkinsonian syndromes Hoehn and Yahr stage 5 Severe cognitive impairment (MMSE < 24) Severe co-morbidity (e.g., cancer) Planned surgical procedure for PD within the intervention period Patients who have already visited the Multidisciplinary Assessment Center

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: I<br>Multifactorial fall prevention program | Other: Multifactorial fall prevention program<br>* Individualised multifactorial fall prevention program containing PD-specific elements as well as generic elements<br>|
| Other: II<br>Usual care | Other: Usual care<br>* Usual care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of falls |  | 8 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of fallers (secondary) |  | 8 months | 
| Falls Efficacy Scale (tertiary) |  | 8 months | 
| Unified Parkinson's Disease rating scale (UPDRS) Motor Examination (part III) (tertiary) |  | 4 months | 
| Parkinson's Disease quality of life questionnaire (PDQL) (tertiary) |  | 8 months | 
| Self-assessment Parkinson's Disease disability scale (SPDDS)(tertiary) |  | 8 months | 
| Caregiver burden assessed with BELA-A-k, SF-36, and HADS (tertiary) |  | 8 months | 
| Number of injurious falls (secondary) |  | 8 months | 
| Number of patients with injurious falls (secondary) |  | 8 months | 
| Freezing of gait (tertiary) |  | 8 months | 
| Costs (secondary) |  | 8 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Accidental falls, Prevention, Treatment effectiveness