Parkinson's DiseasePhase 3REFINE-PDNCT00518648
Reduction of Falls in the Elderly - Parkinson's Disease
A Phase 3 study testing Multifactorial fall prevention program in people with Parkinson's Disease, run by Radboud University Medical Center at 6 sites in Netherlands.
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). Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Multifactorial fall prevention program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 187 participants
- Where
- 6 sitesNetherlands
- Study dates
- Aug 2007to Aug 2010
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Netherlands6 sites
Ziekenhuis Groep Twente, Twenteborg Ziekenhuis
Almelo
Ziekenhuis Rijnstate
Arnhem
Wilhelmina Ziekenhuis Assen
Assen
Ziekenhuis Groep Twente, Streekziekenhuis Midden-Twente
Hengelo
Medisch Centrum Leeuwarden
Leeuwarden
Canisius Wilhelmina Ziekenhuis
Nijmegen
About this study
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.
Read the 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.
- Conditions
- Parkinson's Disease
- Being tested
- Multifactorial fall prevention program, Usual care
- Keywords
- Accidental falls, Prevention, Treatment effectiveness
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multifactorial fall prevention programOther
Individualised multifactorial fall prevention program containing PD-specific elements as well as generic elements
Usual careOther
Usual care
| Study group | Role | What they receive |
|---|---|---|
| I | Experimental | Multifactorial fall prevention program Receives: Other: Multifactorial fall prevention program |
| II | Other | Usual care Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of falls
Measured: 8 months
Secondary outcomes (10)
Number of fallers (secondary)
Measured: 8 months
Falls Efficacy Scale (tertiary)
Measured: 8 months
Unified Parkinson's Disease rating scale (UPDRS) Motor Examination (part III) (tertiary)
Measured: 4 months
Parkinson's Disease quality of life questionnaire (PDQL) (tertiary)
Measured: 8 months
Self-assessment Parkinson's Disease disability scale (SPDDS)(tertiary)
Measured: 8 months
Caregiver burden assessed with BELA-A-k, SF-36, and HADS (tertiary)
Measured: 8 months
Number of injurious falls (secondary)
Measured: 8 months
Number of patients with injurious falls (secondary)
Measured: 8 months
Freezing of gait (tertiary)
Measured: 8 months
Costs (secondary)
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2007 (estimated)
- Study startAug 2007
- Primary completionAug 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 187 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Parkinson Foundation
- Investigators
- Marten Munneke, PhD, Principal investigator, UMC St. RadboudBastiaan R. Bloem, MD, PhD, Principal investigator, UMC St. RadboudMarjolein A. van der Marck, MSc, Principal investigator, UMC St. Radboud
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00518648
- Sponsor's protocol ID
- 2007_RP1.1
- Acronym
- REFINE-PD
- Status last verified
- Nov 2010
- First submitted
- 20 Aug 2007
- Last updated
- 23 Nov 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduction of Falls in the Elderly - Parkinson's Disease
- ClinicalTrials.gov ID
- NCT00518648
- Acronym / sponsor ID
- REFINE-PD / 2007_RP1.1
- Conditions
- Parkinson's Disease
- Keywords
- Accidental falls, Prevention, Treatment effectiveness
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 187 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- National Parkinson Foundation
- Study start
- Aug 2007
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 21 Aug 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| I | Experimental | Other: Multifactorial fall prevention programMultifactorial fall prevention program |
| II | Other | Other: Usual careUsual care |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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:
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multifactorial fall prevention programIndividualised multifactorial fall prevention program containing PD-specific elements as well as generic elements | Other | I |
| Usual careUsual care | Other | II |
Primary outcome
Incidence of falls
Time frame: 8 months
10 secondary outcomes
Number of fallers (secondary)
Time frame: 8 months
Falls Efficacy Scale (tertiary)
Time frame: 8 months
Unified Parkinson's Disease rating scale (UPDRS) Motor Examination (part III) (tertiary)
Time frame: 4 months
Parkinson's Disease quality of life questionnaire (PDQL) (tertiary)
Time frame: 8 months
Self-assessment Parkinson's Disease disability scale (SPDDS)(tertiary)
Time frame: 8 months
Caregiver burden assessed with BELA-A-k, SF-36, and HADS (tertiary)
Time frame: 8 months
Number of injurious falls (secondary)
Time frame: 8 months
Number of patients with injurious falls (secondary)
Time frame: 8 months
Freezing of gait (tertiary)
Time frame: 8 months
Costs (secondary)
Time frame: 8 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marten Munneke, PhD principal investigator
UMC St. Radboud
Bastiaan R. Bloem, MD, PhD principal investigator
UMC St. Radboud
Marjolein A. van der Marck, MSc principal investigator
UMC St. Radboud
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Multifactorial fall prevention program in people with Parkinson's Disease, run by Radboud University Medical Center at 6 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of falls (time frame: 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Nov 2010.