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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Parkinson's Disease

Intervention / Treatment
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* Other: Multidisciplinary Care
* Other: Usual Care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: I<br>Multidisciplinary Care | Other: Multidisciplinary Care<br>* A comprehensive individualised assessment by a dedicated multidisciplinary team (Multidisciplinary Assessment Center) and subsequent treatment by specifically trained health professionals (ParkinsonNet).<br>|
| Other: II<br>Usual Care | Other: Usual Care<br>* No altered organisation of care<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | 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) |  | 4 months | 
| SPDDS(tertiary) |  | 8 months | 
| Modified MACTAR scale(tertiary) |  | 8 months | 
| Parkinson Activity Scale(tertiary) |  | 4 months | 
| Costs (secondary) |  | 8 months | 
| Frequency of falls (tertiary) |  | 8 months | 
| Freezing of Gait Questionnaire (tertiary) |  | 8 months | 
| Falls Efficacy Scale (tertiary) |  | 8 months | 
| Non-Motor Symptom Assessment Scale and Quest for Parkinson's Disease (tertiary) |  | 8 months (Quest) and 4 months (Scale) | 
| Hospital Anxiety and Depression Scale (tertiary) |  | 8 months | 
| Caregiver burden assessed with BELA-A-k (secondary), SF-36 (tertiary), and HADS (tertiary) |  | 8 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Integrated health care system, Treatment effectiveness, Cost effectiveness, Program evaluation