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

Primary Purpose

Parkinson's Disease

Status
Completed
Phase
Phase 3
Locations
Netherlands
Study Type
Interventional
Intervention
Multidisciplinary Care
Usual Care
Sponsored by
Radboud University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Parkinson's Disease focused on measuring Integrated health care system, Treatment effectiveness, Cost effectiveness, Program evaluation

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ziekenhuis Groep Twente, Twenteborg Ziekenhuis
  • Ziekenhuis Rijnstate
  • Wilhelmina Ziekenhuis Assen
  • Ziekenhuis Groep Twente, Streekziekenhuis Midden-Twente
  • Medisch Centrum Leeuwarden
  • Canisius Wilhelmina Ziekenhuis

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

I

II

Arm Description

Multidisciplinary Care

Usual Care

Outcomes

Primary Outcome Measures

Parkinson's Disease Quality of Life Questionnaire (PDQL)
AMC Linear Disability Score (ALDS)

Secondary Outcome Measures

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

Full Information

First Posted
August 20, 2007
Last Updated
November 4, 2010
Sponsor
Radboud University Medical Center
Collaborators
Stichting Nuts Ohra, Porticus
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1. Study Identification

Unique Protocol Identification Number
NCT00518791
Brief Title
Integrated Multidisciplinary Care for Parkinson's Disease: a Controlled Trial
Official Title
Integrated Multidisciplinary Care for Parkinson's Disease: a Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2010
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
August 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Radboud University Medical Center
Collaborators
Stichting Nuts Ohra, Porticus

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
Integrated health care system, Treatment effectiveness, Cost effectiveness, Program evaluation

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
301 (Actual)

8. Arms, Groups, and Interventions

Arm Title
I
Arm Type
Experimental
Arm Description
Multidisciplinary Care
Arm Title
II
Arm Type
Other
Arm Description
Usual Care
Intervention Type
Other
Intervention Name(s)
Multidisciplinary Care
Intervention Description
A comprehensive individualised assessment by a dedicated multidisciplinary team (Multidisciplinary Assessment Center) and subsequent treatment by specifically trained health professionals (ParkinsonNet).
Intervention Type
Other
Intervention Name(s)
Usual Care
Intervention Description
No altered organisation of care
Primary Outcome Measure Information:
Title
Parkinson's Disease Quality of Life Questionnaire (PDQL)
Time Frame
8 months
Title
AMC Linear Disability Score (ALDS)
Time Frame
8 months
Secondary Outcome Measure Information:
Title
SF-36 (secundary;utility score)
Time Frame
8 months
Title
UPDRS Motor Examination (part III)(secondary)
Time Frame
4 months
Title
UPDRS Complications of therapy (part IV)(tertiary)
Time Frame
4 months
Title
SPDDS(tertiary)
Time Frame
8 months
Title
Modified MACTAR scale(tertiary)
Time Frame
8 months
Title
Parkinson Activity Scale(tertiary)
Time Frame
4 months
Title
Costs (secondary)
Time Frame
8 months
Title
Frequency of falls (tertiary)
Time Frame
8 months
Title
Freezing of Gait Questionnaire (tertiary)
Time Frame
8 months
Title
Falls Efficacy Scale (tertiary)
Time Frame
8 months
Title
Non-Motor Symptom Assessment Scale and Quest for Parkinson's Disease (tertiary)
Time Frame
8 months (Quest) and 4 months (Scale)
Title
Hospital Anxiety and Depression Scale (tertiary)
Time Frame
8 months
Title
Caregiver burden assessed with BELA-A-k (secondary), SF-36 (tertiary), and HADS (tertiary)
Time Frame
8 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marten Munneke, PhD
Organizational Affiliation
UMC St Radboud
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bastiaan R Bloem, MD, PhD
Organizational Affiliation
UMC St Radboud
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Marjolein A van der Marck, MSc
Organizational Affiliation
UMC St Radboud
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ziekenhuis Groep Twente, Twenteborg Ziekenhuis
City
Almelo
Country
Netherlands
Facility Name
Ziekenhuis Rijnstate
City
Arnhem
Country
Netherlands
Facility Name
Wilhelmina Ziekenhuis Assen
City
Assen
Country
Netherlands
Facility Name
Ziekenhuis Groep Twente, Streekziekenhuis Midden-Twente
City
Hengelo
Country
Netherlands
Facility Name
Medisch Centrum Leeuwarden
City
Leeuwarden
Country
Netherlands
Facility Name
Canisius Wilhelmina Ziekenhuis
City
Nijmegen
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
23988337
Citation
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.
Results Reference
derived

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

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