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Reduction of Falls in the Elderly - Parkinson's Disease (REFINE-PD)

This study has been completed.
Sponsor:
Collaborator:
National Parkinson Foundation
Information provided by:
Radboud University
ClinicalTrials.gov Identifier:
NCT00518648
First received: August 20, 2007
Last updated: November 22, 2010
Last verified: November 2010
History of Changes
  Purpose

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.


Condition Intervention Phase
Parkinson's Disease
 Other: Multifactorial fall prevention program
Other: Usual care
 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Reduction of Falls in the Elderly - Parkinson's Disease

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Radboud University:

Primary Outcome Measures:
  • Incidence of falls [ Time Frame: 8 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of fallers (secondary) [ Time Frame: 8 months ] [ Designated as safety issue: No ]
  • Falls Efficacy Scale (tertiary) [ Time Frame: 8 months ] [ Designated as safety issue: No ]
  • Unified Parkinson's Disease rating scale (UPDRS) Motor Examination (part III) (tertiary) [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • Parkinson's Disease quality of life questionnaire (PDQL) (tertiary) [ Time Frame: 8 months ] [ Designated as safety issue: No ]
  • Self-assessment Parkinson's Disease disability scale (SPDDS)(tertiary) [ Time Frame: 8 months ] [ Designated as safety issue: No ]
  • Caregiver burden assessed with BELA-A-k, SF-36, and HADS (tertiary) [ Time Frame: 8 months ] [ Designated as safety issue: No ]
  • Number of injurious falls (secondary) [ Time Frame: 8 months ] [ Designated as safety issue: No ]
  • Number of patients with injurious falls (secondary) [ Time Frame: 8 months ] [ Designated as safety issue: No ]
  • Freezing of gait (tertiary) [ Time Frame: 8 months ] [ Designated as safety issue: No ]
  • Costs (secondary) [ Time Frame: 8 months ] [ Designated as safety issue: No ]

Enrollment: 187
Study Start Date: August 2007
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: I
Multifactorial fall prevention program
 Other: Multifactorial fall prevention program
Individualised multifactorial fall prevention program containing PD-specific elements as well as generic elements
II
Usual care
 Other: Usual care
Usual care

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

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00518648

Locations
Netherlands
Ziekenhuis Groep Twente, Twenteborg Ziekenhuis
Almelo, Netherlands
Ziekenhuis Rijnstate
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
Sponsors and Collaborators
Radboud University
National Parkinson Foundation
Investigators
Principal Investigator: 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
  More Information

No publications provided

Responsible Party: Dr. M. Munneke, UMC St Radboud, Neurology
ClinicalTrials.gov Identifier: NCT00518648     History of Changes
Other Study ID Numbers: 2007_RP1.1
Study First Received: August 20, 2007
Last Updated: November 22, 2010
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Radboud University:
Accidental falls
Prevention
Treatment effectiveness

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases

ClinicalTrials.gov processed this record on June 17, 2013