Clinical trial NCT00518648: Reduction of Falls in the Elderly - Parkinson's Disease
Official title: Reduction of Falls in the Elderly - Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Parkinson's Disease
Keywords: Accidental falls
Prevention
Treatment effectiveness
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: National Parkinson Foundation
First posted: 2007-08-21
Enrollment: 187
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of falls
timeFrame: 8 months
Secondary outcomes:
measure: Number of fallers (secondary)
timeFrame: 8 months
measure: Falls Efficacy Scale (tertiary)
timeFrame: 8 months
measure: Unified Parkinson's Disease rating scale (UPDRS) Motor Examination (part III) (tertiary)
timeFrame: 4 months
measure: Parkinson's Disease quality of life questionnaire (PDQL) (tertiary)
timeFrame: 8 months
measure: Self-assessment Parkinson's Disease disability scale (SPDDS)(tertiary)
timeFrame: 8 months
measure: Caregiver burden assessed with BELA-A-k, SF-36, and HADS (tertiary)
timeFrame: 8 months
measure: Number of injurious falls (secondary)
timeFrame: 8 months
measure: Number of patients with injurious falls (secondary)
timeFrame: 8 months
measure: Freezing of gait (tertiary)
timeFrame: 8 months
measure: Costs (secondary)
timeFrame: 8 months
Other outcomes:
Locations:
city: Almelo
country: Netherlands
facility: Ziekenhuis Groep Twente, Twenteborg Ziekenhuis
city: Arnhem
country: Netherlands
facility: Ziekenhuis Rijnstate
city: Assen
country: Netherlands
facility: Wilhelmina Ziekenhuis Assen
city: Hengelo
country: Netherlands
facility: Ziekenhuis Groep Twente, Streekziekenhuis Midden-Twente
city: Leeuwarden
country: Netherlands
facility: Medisch Centrum Leeuwarden
city: Nijmegen
country: Netherlands
facility: Canisius Wilhelmina Ziekenhuis
Study officials:
affiliation: UMC St. Radboud
name: Marten Munneke, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: UMC St. Radboud
name: Bastiaan R. Bloem, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: UMC St. Radboud
name: Marjolein A. van der Marck, MSc
role: PRINCIPAL_INVESTIGATOR
References: