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
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
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
NCT ID
NCT00518791
First Posted
August 20, 2007
Last Updated
November 4, 2010
Sponsor
Radboud University Medical Center
Collaborators
Stichting Nuts Ohra, Porticus
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
Learn more about this trial
Integrated Multidisciplinary Care for Parkinson's Disease: a Controlled Trial
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