Care for Late Stage Parkinsonism

Study Overview
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Brief Summary
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The aim of this project is to evaluate the needs and provision of care for patients in the late stages of Parkinsonism and their carers in several European countries, to compare the effectiveness of different health and social care systems, and to lay the foundation for improved outcomes in this population. The investigators will undertake an in-depth assessment of patients and their care arrangements in a population recruited through networks in six European countries. The systems and procedures that are used in the provision of care will be reviewed through a systematic literature review, interviews and assessments of patients, carers and health care providers, and through a trial comparing assessment by a specialist with management suggestions, guidance and access to telephone advice to that of usual care. Through interviews, questionnaire assessment and review of current health-care and social care arrangement, the investigators will assess the needs, provision of care and use of health-care resources, and their impact on patient and carer outcomes in different countries. National and regional databases will also be interrogated to identify current practice and use of healthcare resources and drug usage. A systematic literature review of the evidence for effective management strategies, analysis of the study data, and evaluation of change in outcomes following specialist review will provide the basis for recommendations in the management of late stage Parkinsonism. The investigators will also evaluate potentially useful outcome measures for use in this patient group. In addition to charting the needs and current care provision for late stage Parkinsonism in different European countries, its cost and effectiveness, and an analysis of health-care and social care predictors of improved outcome, the project will produce a platform for the assessment of patients with late stage Parkinsonism, their current treatment and care provision, as well as guidelines on the management of this late disease phase.

Official Title
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Care for Late Stage Parkinsonism

Conditions
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Parkinson's Disease, Late Stage Parkinson's Disease

Intervention / Treatment
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* Other: Specialist review


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Hoehn and Yahr stage (HY) IV or V in the On-state Disease duration of at least 7 years Exclusion Criteria: Symptomatic Parkinsonism

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 100 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Specialist review<br>Specialist review with individually tailored treatment strategies suggested by specialist | Other: Specialist review<br>* Specialist review with individually tailored treatment strategies suggested by specialist<br>|
| No Intervention: Care as usual<br>Care as usual | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| UPDRS-ADL part | Disability measure | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PDQ-8 or DEMQoL proxy | Quality of Life | 6 months | 
| Zarit carer burden scale | Carer burden | 6 months | 
| Satisfaction with care Likert scale |  | 6 months | 
| MMSE | Mental health | 6 months | 
| NPI | Mental health | 6 months | 
| UPDRS III | PD severity | 6 months | 
| NMSS | PD severity | 6 months | 
| PD milestones | PD severity | 6 months | 
| Basic palliative care assessment | ESAS-PD | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Parkinson's disease, Late stage