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

This study has been completed.
Sponsor:
Collaborators:
Stichting Nuts Ohra
Porticus
Information provided by:
Radboud University
ClinicalTrials.gov Identifier:
NCT00518791
First received: August 20, 2007
Last updated: November 4, 2010
Last verified: October 2010
History of Changes
  Purpose

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 Intervention Phase
Parkinson's Disease
 Other: Multidisciplinary Care
Other: Usual Care
 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care
Official Title: Integrated Multidisciplinary Care for Parkinson's Disease: a Controlled Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Radboud University:

Primary Outcome Measures:
  • Parkinson's Disease Quality of Life Questionnaire (PDQL) [ Time Frame: 8 months ] [ Designated as safety issue: No ]
  • AMC Linear Disability Score (ALDS) [ Time Frame: 8 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • SF-36 (secundary;utility score) [ Time Frame: 8 months ] [ Designated as safety issue: No ]
  • UPDRS Motor Examination (part III)(secondary) [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • UPDRS Complications of therapy (part IV)(tertiary) [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • SPDDS(tertiary) [ Time Frame: 8 months ] [ Designated as safety issue: No ]
  • Modified MACTAR scale(tertiary) [ Time Frame: 8 months ] [ Designated as safety issue: No ]
  • Parkinson Activity Scale(tertiary) [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • Costs (secondary) [ Time Frame: 8 months ] [ Designated as safety issue: No ]
  • Frequency of falls (tertiary) [ Time Frame: 8 months ] [ Designated as safety issue: No ]
  • Freezing of Gait Questionnaire (tertiary) [ Time Frame: 8 months ] [ Designated as safety issue: No ]
  • Falls Efficacy Scale (tertiary) [ Time Frame: 8 months ] [ Designated as safety issue: No ]
  • Non-Motor Symptom Assessment Scale and Quest for Parkinson's Disease (tertiary) [ Time Frame: 8 months (Quest) and 4 months (Scale) ] [ Designated as safety issue: No ]
  • Hospital Anxiety and Depression Scale (tertiary) [ Time Frame: 8 months ] [ Designated as safety issue: No ]
  • Caregiver burden assessed with BELA-A-k (secondary), SF-36 (tertiary), and HADS (tertiary) [ Time Frame: 8 months ] [ Designated as safety issue: No ]

Enrollment: 301
Study Start Date: August 2007
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
II
Usual Care
 Other: Usual Care
No altered organisation of care
Other Name: n.a.

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.

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00518791

Locations
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, Netherlands
Sponsors and Collaborators
Radboud University
Stichting Nuts Ohra
Porticus
Investigators
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

No publications provided

Responsible Party: Dr M Munneke, UMC St Radboud, Neurology
ClinicalTrials.gov Identifier: NCT00518791     History of Changes
Other Study ID Numbers: 2010-IP5.1
Study First Received: August 20, 2007
Last Updated: November 4, 2010
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

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

ClinicalTrials.gov processed this record on May 22, 2013