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

NCT ID: NCT00518791

Last Updated: 2010-11-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

301 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-31

Study Completion Date

2010-08-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Parkinson's Disease

Keywords

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Integrated health care system Treatment effectiveness Cost effectiveness Program evaluation

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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I

Multidisciplinary Care

Group Type EXPERIMENTAL

Multidisciplinary Care

Intervention Type OTHER

A comprehensive individualised assessment by a dedicated multidisciplinary team (Multidisciplinary Assessment Center) and subsequent treatment by specifically trained health professionals (ParkinsonNet).

II

Usual Care

Group Type OTHER

Usual Care

Intervention Type OTHER

No altered organisation of care

Interventions

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Multidisciplinary Care

A comprehensive individualised assessment by a dedicated multidisciplinary team (Multidisciplinary Assessment Center) and subsequent treatment by specifically trained health professionals (ParkinsonNet).

Intervention Type OTHER

Usual Care

No altered organisation of care

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stichting Nuts Ohra

OTHER

Sponsor Role collaborator

Porticus

UNKNOWN

Sponsor Role collaborator

Radboud University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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UMC St Radboud, Neurology

Principal Investigators

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Marten Munneke, PhD

Role: PRINCIPAL_INVESTIGATOR

UMC St Radboud

Bastiaan R Bloem, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

UMC St Radboud

Marjolein A van der Marck, MSc

Role: PRINCIPAL_INVESTIGATOR

UMC St Radboud

Locations

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Ziekenhuis Groep Twente, Twenteborg Ziekenhuis

Almelo, , Netherlands

Site Status

Ziekenhuis Rijnstate

Arnhem, , Netherlands

Site Status

Wilhelmina Ziekenhuis Assen

Assen, , Netherlands

Site Status

Ziekenhuis Groep Twente, Streekziekenhuis Midden-Twente

Hengelo, , Netherlands

Site Status

Medisch Centrum Leeuwarden

Leeuwarden, , Netherlands

Site Status

Canisius Wilhelmina Ziekenhuis

Nijmegen, , Netherlands

Site Status

Countries

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Netherlands

References

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van der Marck MA, Munneke M, Mulleners W, Hoogerwaard EM, Borm GF, Overeem S, Bloem BR; IMPACT study group. Integrated multidisciplinary care in Parkinson's disease: a non-randomised, controlled trial (IMPACT). Lancet Neurol. 2013 Oct;12(10):947-56. doi: 10.1016/S1474-4422(13)70196-0. Epub 2013 Aug 27.

Reference Type DERIVED
PMID: 23988337 (View on PubMed)

Other Identifiers

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2010-IP5.1

Identifier Type: -

Identifier Source: org_study_id