NCT00518648

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
187

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Aug 2007

Typical duration for phase_3

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2007

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

August 20, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 21, 2007

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
Last Updated

November 23, 2010

Status Verified

November 1, 2010

Enrollment Period

3 years

First QC Date

August 20, 2007

Last Update Submit

November 22, 2010

Conditions

Parkinson's Disease

Keywords

Accidental fallsPreventionTreatment effectiveness

Outcome Measures

Primary Outcomes (1)

  • Incidence of falls

    8 months

Secondary Outcomes (10)

  • Number of fallers (secondary)

    8 months

  • Falls Efficacy Scale (tertiary)

    8 months

  • Unified Parkinson's Disease rating scale (UPDRS) Motor Examination (part III) (tertiary)

    4 months

  • Parkinson's Disease quality of life questionnaire (PDQL) (tertiary)

    8 months

  • Self-assessment Parkinson's Disease disability scale (SPDDS)(tertiary)

    8 months

  • +5 more secondary outcomes

Study Arms (2)

I

EXPERIMENTAL

Multifactorial fall prevention program

Other: Multifactorial fall prevention program

II

OTHER

Usual care

Other: Usual care

Interventions

Multifactorial fall prevention programOTHER

Individualised multifactorial fall prevention program containing PD-specific elements as well as generic elements

I
Usual careOTHER

Usual care

II

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Ziekenhuis Groep Twente, Twenteborg Ziekenhuis

Almelo, Netherlands

Location

Ziekenhuis Rijnstate

Arnhem, Netherlands

Location

Wilhelmina Ziekenhuis Assen

Assen, Netherlands

Location

Ziekenhuis Groep Twente, Streekziekenhuis Midden-Twente

Hengelo, Netherlands

Location

Medisch Centrum Leeuwarden

Leeuwarden, Netherlands

Location

Canisius Wilhelmina Ziekenhuis

Nijmegen, Netherlands

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 20, 2007

First Posted

August 21, 2007

Study Start

August 1, 2007

Primary Completion

August 1, 2010

Study Completion

August 1, 2010

Last Updated

November 23, 2010

Record last verified: 2010-11

Locations

NL(6)