Integrated Multidisciplinary Care for Parkinson's Disease: a Controlled Trial
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| First Received Date ICMJE | August 20, 2007 | ||||||||||||
| Last Updated Date | November 4, 2010 | ||||||||||||
| Start Date ICMJE | August 2007 | ||||||||||||
| Primary Completion Date | August 2010 (final data collection date for primary outcome measure) | ||||||||||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE |
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| Change History | Complete list of historical versions of study NCT00518791 on ClinicalTrials.gov Archive Site | ||||||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Outcome Measures ICMJE | Not Provided | ||||||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||||||
| Descriptive Information | |||||||||||||
| Brief Title ICMJE | Integrated Multidisciplinary Care for Parkinson's Disease: a Controlled Trial | ||||||||||||
| Official Title ICMJE | Integrated Multidisciplinary Care for Parkinson's Disease: a Controlled Trial | ||||||||||||
| 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||||||||||
| Study Phase | Phase 3 | ||||||||||||
| Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Supportive Care |
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| Condition ICMJE | Parkinson's Disease | ||||||||||||
| Intervention ICMJE |
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| Publications * | Not Provided | ||||||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||||||
| Recruitment Status ICMJE | Completed | ||||||||||||
| Enrollment ICMJE | 301 | ||||||||||||
| Completion Date | August 2010 | ||||||||||||
| Primary Completion Date | August 2010 (final data collection date for primary outcome measure) | ||||||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||||||
| Ages | 20 Years to 80 Years | ||||||||||||
| Accepts Healthy Volunteers | No | ||||||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||
| Location Countries ICMJE | Netherlands | ||||||||||||
| Administrative Information | |||||||||||||
| NCT Number ICMJE | NCT00518791 | ||||||||||||
| Other Study ID Numbers ICMJE | 2010-IP5.1 | ||||||||||||
| Has Data Monitoring Committee | No | ||||||||||||
| Responsible Party | Dr M Munneke, UMC St Radboud, Neurology | ||||||||||||
| Study Sponsor ICMJE | Radboud University | ||||||||||||
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| Investigators ICMJE |
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| Information Provided By | Radboud University | ||||||||||||
| Verification Date | October 2010 | ||||||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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