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

November 22, 2010 updated by: Radboud University Medical Center
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

187

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Almelo, Netherlands
        • Ziekenhuis Groep Twente, Twenteborg Ziekenhuis
      • Arnhem, Netherlands
        • Ziekenhuis Rijnstate
      • Assen, Netherlands
        • Wilhelmina Ziekenhuis Assen
      • Hengelo, Netherlands
        • Ziekenhuis Groep Twente, Streekziekenhuis Midden-Twente
      • Leeuwarden, Netherlands
        • Medisch Centrum Leeuwarden
      • Nijmegen, Netherlands
        • Canisius Wilhelmina Ziekenhuis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
OTHER: II
Usual care
Other: Usual care
Usual care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of falls
Time Frame: 8 months
8 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Costs (secondary)
Time Frame: 8 months
8 months
Falls Efficacy Scale (tertiary)
Time Frame: 8 months
8 months
Number of fallers (secondary)
Time Frame: 8 months
8 months
Unified Parkinson's Disease rating scale (UPDRS) Motor Examination (part III) (tertiary)
Time Frame: 4 months
4 months
Parkinson's Disease quality of life questionnaire (PDQL) (tertiary)
Time Frame: 8 months
8 months
Self-assessment Parkinson's Disease disability scale (SPDDS)(tertiary)
Time Frame: 8 months
8 months
Caregiver burden assessed with BELA-A-k, SF-36, and HADS (tertiary)
Time Frame: 8 months
8 months
Number of injurious falls (secondary)
Time Frame: 8 months
8 months
Number of patients with injurious falls (secondary)
Time Frame: 8 months
8 months
Freezing of gait (tertiary)
Time Frame: 8 months
8 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Radboud University Medical Center

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2007

Primary Completion (ACTUAL)

August 1, 2010

Study Completion (ACTUAL)

August 1, 2010

Study Registration Dates

First Submitted

August 20, 2007

First Submitted That Met QC Criteria

August 20, 2007

First Posted (ESTIMATE)

August 21, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

November 23, 2010

Last Update Submitted That Met QC Criteria

November 22, 2010

Last Verified

November 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2007_RP1.1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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