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

November 4, 2010 updated by: Radboud University Medical Center
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

301

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Almelo, Netherlands
        • Ziekenhuis Groep Twente, Twenteborg Ziekenhuis
      • Arnhem, Netherlands
        • Ziekenhuis Rijnstate
      • Assen, Netherlands
        • Wilhelmina Ziekenhuis Assen
      • Hengelo, Netherlands
        • Ziekenhuis Groep Twente, Streekziekenhuis Midden-Twente
      • Leeuwarden, Netherlands
        • Medisch Centrum Leeuwarden
      • Nijmegen, Netherlands
        • Canisius Wilhelmina Ziekenhuis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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: II
Usual Care
Other: Usual Care
No altered organisation of care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Parkinson's Disease Quality of Life Questionnaire (PDQL)
Time Frame: 8 months
8 months
AMC Linear Disability Score (ALDS)
Time Frame: 8 months
8 months

Secondary Outcome Measures

Outcome Measure
Time Frame
SF-36 (secundary;utility score)
Time Frame: 8 months
8 months
UPDRS Motor Examination (part III)(secondary)
Time Frame: 4 months
4 months
UPDRS Complications of therapy (part IV)(tertiary)
Time Frame: 4 months
4 months
SPDDS(tertiary)
Time Frame: 8 months
8 months
Modified MACTAR scale(tertiary)
Time Frame: 8 months
8 months
Parkinson Activity Scale(tertiary)
Time Frame: 4 months
4 months
Costs (secondary)
Time Frame: 8 months
8 months
Frequency of falls (tertiary)
Time Frame: 8 months
8 months
Freezing of Gait Questionnaire (tertiary)
Time Frame: 8 months
8 months
Falls Efficacy Scale (tertiary)
Time Frame: 8 months
8 months
Non-Motor Symptom Assessment Scale and Quest for Parkinson's Disease (tertiary)
Time Frame: 8 months (Quest) and 4 months (Scale)
8 months (Quest) and 4 months (Scale)
Hospital Anxiety and Depression Scale (tertiary)
Time Frame: 8 months
8 months
Caregiver burden assessed with BELA-A-k (secondary), SF-36 (tertiary), and HADS (tertiary)
Time Frame: 8 months
8 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Radboud University Medical Center

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2007

Primary Completion (Actual)

August 1, 2010

Study Completion (Actual)

August 1, 2010

Study Registration Dates

First Submitted

August 20, 2007

First Submitted That Met QC Criteria

August 20, 2007

First Posted (Estimate)

August 21, 2007

Study Record Updates

Last Update Posted (Estimate)

November 5, 2010

Last Update Submitted That Met QC Criteria

November 4, 2010

Last Verified

October 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2010-IP5.1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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