Integrated Multidisciplinary Care for Parkinson's Disease: a Cluster Controlled Trial - Full Text View

Sponsors and Collaborators:	Radboud University Stichting Nuts Ohra Porticus
Information provided by:	Radboud University
ClinicalTrials.gov Identifier:	NCT00518791

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 III

Genetics Home Reference related topics: familial paroxysmal nonkinesigenic dyskinesia Parkinson disease

MedlinePlus related topics: Parkinson's Disease

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Supportive Care, Non-Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Efficacy Study
Official Title:	Integrated Multidisciplinary Care for Parkinson's Disease: a Cluster Controlled Trial

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

Estimated Enrollment:	450
Study Start Date:	August 2007
Estimated Study Completion Date:	May 2010
Estimated Primary Completion Date:	May 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
I: Experimental 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 (ParkNet).
II Usual Care	Other: Usual Care No altered organisation of care

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

Contacts

Contact: Marten Munneke, PhD	+31 24 361 5202	m.munneke@neuro.umcn.nl
Contact: Bastiaan R Bloem, MD, PhD	+31 24 361 5202	b.bloem@neuro.umcn.nl

Locations

Netherlands
Canisius Wilhelmina Ziekenhuis	Recruiting
Nijmegen, Netherlands
Ziekenhuis Rijnstate	Recruiting
Arnhem, 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

Responsible Party:	UMC St Radboud, Neurology ( Dr M Munneke )
Study ID Numbers:	2007-IP4.4
Study First Received:	August 20, 2007
Last Updated:	September 1, 2008
ClinicalTrials.gov Identifier:	NCT00518791
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

Study placed in the following topic categories:

Ganglion Cysts
Movement Disorders
Parkinson Disease
Basal Ganglia Diseases

Central Nervous System Diseases
Parkinsonian Disorders
Neurodegenerative Diseases
Brain Diseases

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 15, 2009