Reduction of Falls in the Elderly - Parkinson's Disease
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 187
- Locations
- 6
- Primary Endpoint
- Incidence of falls
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 20 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
I
Multifactorial fall prevention program
Intervention: Multifactorial fall prevention program (Other)
II
Usual care
Intervention: Usual care (Other)
Outcomes
Primary Outcomes
Incidence of falls
Time Frame: 8 months
Secondary Outcomes
- 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)