Reduction of Falls in the Elderly - Parkinson's Disease (REFINE-PD)
Primary Purpose
Parkinson's Disease
Status
Completed
Phase
Phase 3
Locations
Netherlands
Study Type
Interventional
Intervention
Multifactorial fall prevention program
Usual care
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson's Disease focused on measuring Accidental falls, Prevention, Treatment effectiveness
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
Sites / Locations
- Ziekenhuis Groep Twente, Twenteborg Ziekenhuis
- Ziekenhuis Rijnstate
- Wilhelmina Ziekenhuis Assen
- Ziekenhuis Groep Twente, Streekziekenhuis Midden-Twente
- Medisch Centrum Leeuwarden
- Canisius Wilhelmina Ziekenhuis
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
I
II
Arm Description
Multifactorial fall prevention program
Usual care
Outcomes
Primary Outcome Measures
Incidence of falls
Secondary Outcome Measures
Number of fallers (secondary)
Falls Efficacy Scale (tertiary)
Unified Parkinson's Disease rating scale (UPDRS) Motor Examination (part III) (tertiary)
Parkinson's Disease quality of life questionnaire (PDQL) (tertiary)
Self-assessment Parkinson's Disease disability scale (SPDDS)(tertiary)
Caregiver burden assessed with BELA-A-k, SF-36, and HADS (tertiary)
Number of injurious falls (secondary)
Number of patients with injurious falls (secondary)
Freezing of gait (tertiary)
Costs (secondary)
Full Information
NCT ID
NCT00518648
First Posted
August 20, 2007
Last Updated
November 22, 2010
Sponsor
Radboud University Medical Center
Collaborators
National Parkinson Foundation
1. Study Identification
Unique Protocol Identification Number
NCT00518648
Brief Title
Reduction of Falls in the Elderly - Parkinson's Disease
Acronym
REFINE-PD
Official Title
Reduction of Falls in the Elderly - Parkinson's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
November 2010
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
August 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Radboud University Medical Center
Collaborators
National Parkinson Foundation
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
Accidental falls, Prevention, Treatment effectiveness
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
187 (Actual)
8. Arms, Groups, and Interventions
Arm Title
I
Arm Type
Experimental
Arm Description
Multifactorial fall prevention program
Arm Title
II
Arm Type
Other
Arm Description
Usual care
Intervention Type
Other
Intervention Name(s)
Multifactorial fall prevention program
Intervention Description
Individualised multifactorial fall prevention program containing PD-specific elements as well as generic elements
Intervention Type
Other
Intervention Name(s)
Usual care
Intervention Description
Usual care
Primary Outcome Measure Information:
Title
Incidence of falls
Time Frame
8 months
Secondary Outcome Measure Information:
Title
Number of fallers (secondary)
Time Frame
8 months
Title
Falls Efficacy Scale (tertiary)
Time Frame
8 months
Title
Unified Parkinson's Disease rating scale (UPDRS) Motor Examination (part III) (tertiary)
Time Frame
4 months
Title
Parkinson's Disease quality of life questionnaire (PDQL) (tertiary)
Time Frame
8 months
Title
Self-assessment Parkinson's Disease disability scale (SPDDS)(tertiary)
Time Frame
8 months
Title
Caregiver burden assessed with BELA-A-k, SF-36, and HADS (tertiary)
Time Frame
8 months
Title
Number of injurious falls (secondary)
Time Frame
8 months
Title
Number of patients with injurious falls (secondary)
Time Frame
8 months
Title
Freezing of gait (tertiary)
Time Frame
8 months
Title
Costs (secondary)
Time Frame
8 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marten Munneke, PhD
Organizational Affiliation
UMC St. Radboud
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bastiaan R. Bloem, MD, PhD
Organizational Affiliation
UMC St. Radboud
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Marjolein A. van der Marck, MSc
Organizational Affiliation
UMC St. Radboud
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ziekenhuis Groep Twente, Twenteborg Ziekenhuis
City
Almelo
Country
Netherlands
Facility Name
Ziekenhuis Rijnstate
City
Arnhem
Country
Netherlands
Facility Name
Wilhelmina Ziekenhuis Assen
City
Assen
Country
Netherlands
Facility Name
Ziekenhuis Groep Twente, Streekziekenhuis Midden-Twente
City
Hengelo
Country
Netherlands
Facility Name
Medisch Centrum Leeuwarden
City
Leeuwarden
Country
Netherlands
Facility Name
Canisius Wilhelmina Ziekenhuis
City
Nijmegen
Country
Netherlands
12. IPD Sharing Statement
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Reduction of Falls in the Elderly - Parkinson's Disease
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