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Integrated Multidisciplinary Care for Parkinson's Disease: a Controlled Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00518791
Recruitment Status : Completed
First Posted : August 21, 2007
Last Update Posted : November 5, 2010
Information provided by:

Study Description
Brief Summary:
The aim of the present study is to evaluate the (cost) effectiveness of a new health care system in which an individualised multidisciplinary assessment is given to patients with Parkinson's Disease(PD)in combination with treatment by a dedicated team of specifically trained health professionals, compared to usual care. Overall, we anticipate to gain more insight in the clinical effectiveness and health care costs of multidisciplinary treatment in PD.

Condition or disease Intervention/treatment Phase
Parkinson's Disease Other: Multidisciplinary Care Other: Usual Care Phase 3

Detailed Description:

PD is a complex disorder, with motor as well as non-motor symptoms. Despite the complexity of PD, management of the disease is often 'monodisciplinary' since most patients are only treated by a neurologist. Stimulating compensatory strategies by allied health professionals might offer additional therapeutic relief, but this assumption is mainly based on theoretical arguments and expert opinion. Even less is known about the claim that a multidisciplinary team of multiple professionals active in complementary domains (e.g. physiotherapy, occupational therapy and speech therapy) is superior to management by each of these professionals alone.

This study anticipates to provide more insight in the clinical effectiveness and health care costs of multidisciplinary treatment in PD. Therefore, our multidisciplinary care concept (a comprehensive assessment by a dedicated multidisciplinary team and subsequent treatment by specifically trained health professionals) that is tailored to the patients' individual needs will be compared to usual care in terms of effectiveness and costs.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 301 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: Integrated Multidisciplinary Care for Parkinson's Disease: a Controlled Trial
Study Start Date : August 2007
Primary Completion Date : August 2010
Study Completion Date : August 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: I
Multidisciplinary Care
Other: Multidisciplinary Care
A comprehensive individualised assessment by a dedicated multidisciplinary team (Multidisciplinary Assessment Center) and subsequent treatment by specifically trained health professionals (ParkinsonNet).
Other Name: n.a.
Usual Care
Other: Usual Care
No altered organisation of care
Other Name: n.a.

Outcome Measures

Primary Outcome Measures :
  1. Parkinson's Disease Quality of Life Questionnaire (PDQL) [ Time Frame: 8 months ]
  2. AMC Linear Disability Score (ALDS) [ Time Frame: 8 months ]

Secondary Outcome Measures :
  1. SF-36 (secundary;utility score) [ Time Frame: 8 months ]
  2. UPDRS Motor Examination (part III)(secondary) [ Time Frame: 4 months ]
  3. UPDRS Complications of therapy (part IV)(tertiary) [ Time Frame: 4 months ]
  4. SPDDS(tertiary) [ Time Frame: 8 months ]
  5. Modified MACTAR scale(tertiary) [ Time Frame: 8 months ]
  6. Parkinson Activity Scale(tertiary) [ Time Frame: 4 months ]
  7. Costs (secondary) [ Time Frame: 8 months ]
  8. Frequency of falls (tertiary) [ Time Frame: 8 months ]
  9. Freezing of Gait Questionnaire (tertiary) [ Time Frame: 8 months ]
  10. Falls Efficacy Scale (tertiary) [ Time Frame: 8 months ]
  11. Non-Motor Symptom Assessment Scale and Quest for Parkinson's Disease (tertiary) [ Time Frame: 8 months (Quest) and 4 months (Scale) ]
  12. Hospital Anxiety and Depression Scale (tertiary) [ Time Frame: 8 months ]
  13. Caregiver burden assessed with BELA-A-k (secondary), SF-36 (tertiary), and HADS (tertiary) [ Time Frame: 8 months ]

Eligibility Criteria

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients with Idiopathic PD, diagnosed according to the Brain Bank Criteria of the UK Parkinson's Disease Society
  • Regular control by the neurologist
  • Living independently in the community
  • Able to complete the trial questionnaires

Exclusion Criteria:

  • Atypical parkinsonian syndromes
  • Hoehn and Yahr stage 5
  • Severe cognitive impairment (MMSE<24)
  • Presence of other neurological disorders
  • Severe co-morbidity (e.g. cancer)
  • Planned surgical procedure for PD within the intervention period
  • Patients who have already visited the Multidisciplinary Assessment Center
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00518791

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, Netherlands
Sponsors and Collaborators
Radboud University
Stichting Nuts Ohra
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
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr M Munneke, UMC St Radboud, Neurology
ClinicalTrials.gov Identifier: NCT00518791     History of Changes
Other Study ID Numbers: 2010-IP5.1
First Posted: August 21, 2007    Key Record Dates
Last Update Posted: November 5, 2010
Last Verified: October 2010

Keywords provided by Radboud University:
Integrated health care system
Treatment effectiveness
Cost effectiveness
Program evaluation

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases