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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
187
Individualised multifactorial fall prevention program containing PD-specific elements as well as generic elements
Usual care
Ziekenhuis Groep Twente, Twenteborg Ziekenhuis
Almelo, Netherlands
Ziekenhuis Rijnstate
Arnhem, Netherlands
Wilhelmina Ziekenhuis Assen
Assen, Netherlands
Ziekenhuis Groep Twente, Streekziekenhuis Midden-Twente
Hengelo, Netherlands
Incidence of falls
Time frame: 8 months
Number of fallers (secondary)
Time frame: 8 months
Falls Efficacy Scale (tertiary)
Time frame: 8 months
Unified Parkinson's Disease rating scale (UPDRS) Motor Examination (part III) (tertiary)
Time frame: 4 months
Parkinson's Disease quality of life questionnaire (PDQL) (tertiary)
Time frame: 8 months
Self-assessment Parkinson's Disease disability scale (SPDDS)(tertiary)
Time frame: 8 months
Caregiver burden assessed with BELA-A-k, SF-36, and HADS (tertiary)
Time frame: 8 months
Number of injurious falls (secondary)
Time frame: 8 months
Number of patients with injurious falls (secondary)
Time frame: 8 months
Freezing of gait (tertiary)
Time frame: 8 months
Costs (secondary)
Time frame: 8 months
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Medisch Centrum Leeuwarden
Leeuwarden, Netherlands
Canisius Wilhelmina Ziekenhuis
Nijmegen, Netherlands