Clinical trial NCT02333175: Care for Late Stage Parkinsonism
Official title: Care for Late Stage Parkinsonism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson's Disease
Late Stage Parkinson's Disease
Keywords: Parkinson's disease, Late stage
Lead sponsor: University College, London
Sponsor class: OTHER
Collaborators: name: Philipps University Marburg
name: Instituto de Medicina Molecular João Lobo Antunes
name: University Medical Center Nijmegen
name: Lund University
name: University Hospital, Bordeaux
name: Ludwig-Maximilians - University of Munich
First posted: 2015-01-07
Enrollment: 184
Sex: ALL
Minimum age (years): 1
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: UPDRS-ADL part
timeFrame: 6 months
Secondary outcomes:
measure: PDQ-8 or DEMQoL proxy
timeFrame: 6 months
measure: Zarit carer burden scale
timeFrame: 6 months
measure: Satisfaction with care Likert scale
timeFrame: 6 months
measure: MMSE
timeFrame: 6 months
measure: NPI
timeFrame: 6 months
measure: UPDRS III
timeFrame: 6 months
measure: NMSS
timeFrame: 6 months
measure: PD milestones
timeFrame: 6 months
measure: Basic palliative care assessment
timeFrame: 6 months
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: University of Bordeaux
city: Munich
country: Germany
facility: University of Munich
state: Bavaria
city: Marburg
country: Germany
facility: University of Marburg
city: Nijmegen
country: Netherlands
facility: Radboud university medical center
city: Lisbon
country: Portugal
facility: Instituto de Medicina Molecular
city: Lund
country: Sweden
facility: Lund University
city: London
country: United Kingdom
facility: University College London
Study officials:
References:
citation: Kruse C, Kretschmer S, Lipinski A, Verheyen M, Mengel D, Balzer-Geldsetzer M, Lorenzl S, Richinger C, Schmotz C, Tonges L, Woitalla D, Klebe S, Schrag A, Dodel R. Resource Utilization of Patients with Parkinson's Disease in the Late Stages of the Disease in Germany: Data from the CLaSP Study. Pharmacoeconomics. 2021 May;39(5):601-615. doi: 10.1007/s40273-021-01011-y. Epub 2021 Mar 19.
citation: Balzer-Geldsetzer M, Ferreira J, Odin P, Bloem BR, Meissner WG, Lorenzl S, Wittenberg M, Dodel R, Schrag A. Study protocol: Care of Late-Stage Parkinsonism (CLaSP): a longitudinal cohort study. BMC Neurol. 2018 Nov 5;18(1):185. doi: 10.1186/s12883-018-1184-3.