Reduction of Falls in the Elderly - Parkinson's Disease
- Conditions
- Parkinson's Disease
- Interventions
- Other: Multifactorial fall prevention programOther: Usual care
- Registration Number
- NCT00518648
- Lead Sponsor
- Radboud University Medical Center
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 187
-
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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description I Multifactorial fall prevention program Multifactorial fall prevention program II Usual care Usual care
- Primary Outcome Measures
Name Time Method Incidence of falls 8 months
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (6)
Ziekenhuis Groep Twente, Twenteborg Ziekenhuis
🇳🇱Almelo, Netherlands
Wilhelmina Ziekenhuis Assen
🇳🇱Assen, Netherlands
Ziekenhuis Rijnstate
🇳🇱Arnhem, Netherlands
Ziekenhuis Groep Twente, Streekziekenhuis Midden-Twente
🇳🇱Hengelo, Netherlands
Medisch Centrum Leeuwarden
🇳🇱Leeuwarden, Netherlands
Canisius Wilhelmina Ziekenhuis
🇳🇱Nijmegen, Netherlands