Integrated Multidisciplinary Care for Parkinson's Disease... | NCT00518791

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

NCT00518791

Sponsor

Radboud University Medical Center

Status

Completed

Last Update Posted

Nov 5, 2010Estimated

Enrollment

301Actual

Phase

Phase 3

Conditions

Parkinson's Disease

Interventions

Multidisciplinary Care
Usual Care

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2007

Primary Completion Date

Aug 2010Actual

Completion Date

Aug 2010Actual

First Submitted Date

Aug 20, 2007

First Submission Date that Met QC Criteria

Aug 20, 2007

First Posted Date

Aug 21, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 4, 2010

Last Update Posted Date

Nov 5, 2010Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Radboud University Medical CenterOTHER

Collaborators

Name	Class
Stichting Nuts Ohra	OTHER
Porticus	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

301Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
I	Experimental	Multidisciplinary Care	Other: Multidisciplinary Care
II	Other	Usual Care	Other: Usual Care

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Multidisciplinary Care	Other	A comprehensive individualised assessment by a dedicated multidisciplinary team (Multidisciplinary Assessment Center) and subsequent treatment by specifically trained health professionals (ParkinsonNet).

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
SF-36 (secundary;utility score)		8 months
UPDRS Motor Examination (part III)(secondary)		4 months
UPDRS Complications of therapy (part IV)(tertiary)

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
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	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ziekenhuis Groep Twente, Twenteborg Ziekenhuis		Almelo			Netherlands
Ziekenhuis Rijnstate

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23988337	Derived	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.

ID	Term
D020734	Parkinsonian Disorders
D001480	Basal Ganglia Diseases
D001927	Brain Diseases
D002493	Central Nervous System Diseases

ID	Term
D010346	Patient Care Management
D006298	Health Services Administration