Integrated Multidisciplinary Care for Parkinson's Disease: a Controlled Trial
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|ClinicalTrials.gov Identifier: NCT00518791|
Recruitment Status : Completed
First Posted : August 21, 2007
Last Update Posted : November 5, 2010
|Condition or disease||Intervention/treatment||Phase|
|Parkinson's Disease||Other: Multidisciplinary Care Other: Usual Care||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||301 participants|
|Intervention Model:||Parallel Assignment|
|Primary Purpose:||Supportive Care|
|Official Title:||Integrated Multidisciplinary Care for Parkinson's Disease: a Controlled Trial|
|Study Start Date :||August 2007|
|Actual Primary Completion Date :||August 2010|
|Actual Study Completion Date :||August 2010|
Other: Multidisciplinary Care
A comprehensive individualised assessment by a dedicated multidisciplinary team (Multidisciplinary Assessment Center) and subsequent treatment by specifically trained health professionals (ParkinsonNet).
Other Name: n.a.
Other: Usual Care
No altered organisation of care
Other Name: n.a.
- Parkinson's Disease Quality of Life Questionnaire (PDQL) [ Time Frame: 8 months ]
- AMC Linear Disability Score (ALDS) [ Time Frame: 8 months ]
- SF-36 (secundary;utility score) [ Time Frame: 8 months ]
- UPDRS Motor Examination (part III)(secondary) [ Time Frame: 4 months ]
- UPDRS Complications of therapy (part IV)(tertiary) [ Time Frame: 4 months ]
- SPDDS(tertiary) [ Time Frame: 8 months ]
- Modified MACTAR scale(tertiary) [ Time Frame: 8 months ]
- Parkinson Activity Scale(tertiary) [ Time Frame: 4 months ]
- Costs (secondary) [ Time Frame: 8 months ]
- Frequency of falls (tertiary) [ Time Frame: 8 months ]
- Freezing of Gait Questionnaire (tertiary) [ Time Frame: 8 months ]
- Falls Efficacy Scale (tertiary) [ Time Frame: 8 months ]
- Non-Motor Symptom Assessment Scale and Quest for Parkinson's Disease (tertiary) [ Time Frame: 8 months (Quest) and 4 months (Scale) ]
- Hospital Anxiety and Depression Scale (tertiary) [ Time Frame: 8 months ]
- Caregiver burden assessed with BELA-A-k (secondary), SF-36 (tertiary), and HADS (tertiary) [ Time Frame: 8 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00518791
|Ziekenhuis Groep Twente, Twenteborg Ziekenhuis|
|Wilhelmina Ziekenhuis Assen|
|Ziekenhuis Groep Twente, Streekziekenhuis Midden-Twente|
|Medisch Centrum Leeuwarden|
|Canisius Wilhelmina Ziekenhuis|
|Principal Investigator:||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|