Reduction of Falls in the Elderly - Parkinson's Disease

Parkinson's Disease Clinical Trial

— REFINE-PD  

Official title:

Reduction of Falls in the Elderly - Parkinson's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00518648
• Other study ID #: 2007_RP1.1
• Status: Completed
• Phase: Phase 3
• First received: August 20, 2007
• Last updated: November 22, 2010
• Start date: August 2007
• Est. completion date: August 2010

Study information

• Verified date: November 2010
• Source: Radboud University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 187
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Other:
• Multifactorial fall prevention program
Individualised multifactorial fall prevention program containing PD-specific elements as well as generic elements
• Usual care
Usual care

Locations

Country	Name	City	State
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

Sponsors (2)

Lead Sponsor	Collaborator
Radboud University	National Parkinson Foundation

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of falls		8 months	No
Secondary	Number of fallers (secondary)		8 months	No
Secondary	Falls Efficacy Scale (tertiary)		8 months	No
Secondary	Unified Parkinson's Disease rating scale (UPDRS) Motor Examination (part III) (tertiary)		4 months	No
Secondary	Parkinson's Disease quality of life questionnaire (PDQL) (tertiary)		8 months	No
Secondary	Self-assessment Parkinson's Disease disability scale (SPDDS)(tertiary)		8 months	No
Secondary	Caregiver burden assessed with BELA-A-k, SF-36, and HADS (tertiary)		8 months	No
Secondary	Number of injurious falls (secondary)		8 months	No
Secondary	Number of patients with injurious falls (secondary)		8 months	No
Secondary	Freezing of gait (tertiary)		8 months	No
Secondary	Costs (secondary)		8 months	No