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| Name | Class |
|---|---|
| National Parkinson Foundation | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| I | Experimental | Multifactorial fall prevention program |
|
| II | Other | Usual care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multifactorial fall prevention program | Other | Individualised multifactorial fall prevention program containing PD-specific elements as well as generic elements |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of falls | 8 months |
| 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) |
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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:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marten Munneke, PhD | UMC St. Radboud | Principal Investigator |
| Bastiaan R. Bloem, MD, PhD | UMC St. Radboud | Principal Investigator |
| Marjolein A. van der Marck, MSc | UMC St. Radboud | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ziekenhuis Groep Twente, Twenteborg Ziekenhuis | Almelo | Netherlands | ||||
| Ziekenhuis Rijnstate |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| Usual care | Other | Usual care |
|
| 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 |
| Arnhem |
| Netherlands |
| Wilhelmina Ziekenhuis Assen | Assen | Netherlands |
| Ziekenhuis Groep Twente, Streekziekenhuis Midden-Twente | Hengelo | Netherlands |
| Medisch Centrum Leeuwarden | Leeuwarden | Netherlands |
| Canisius Wilhelmina Ziekenhuis | Nijmegen | Netherlands |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |