Care for Late Stage Parkinsonism
CLaSP
1 other identifier
interventional
184
6 countries
7
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2014
Longer than P75 for not_applicable
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2014
CompletedFirst Submitted
Initial submission to the registry
September 25, 2014
CompletedFirst Posted
Study publicly available on registry
January 7, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2019
CompletedApril 28, 2021
April 1, 2021
4.6 years
September 25, 2014
April 27, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
UPDRS-ADL part
Disability measure
6 months
Secondary Outcomes (9)
PDQ-8 or DEMQoL proxy
6 months
Zarit carer burden scale
6 months
Satisfaction with care Likert scale
6 months
MMSE
6 months
NPI
6 months
- +4 more secondary outcomes
Study Arms (2)
Specialist review
ACTIVE COMPARATORSpecialist review with individually tailored treatment strategies suggested by specialist
Care as usual
NO INTERVENTIONCare as usual
Interventions
Specialist review with individually tailored treatment strategies suggested by specialist
Eligibility Criteria
You may qualify if:
- Hoehn and Yahr stage (HY) IV or V in the "On"-state
- Disease duration of at least 7 years
You may not qualify if:
- Symptomatic Parkinsonism
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University College, Londonlead
- Philipps University Marburgcollaborator
- Instituto de Medicina Molecular João Lobo Antunescollaborator
- University Medical Center Nijmegencollaborator
- Lund Universitycollaborator
- University Hospital, Bordeauxcollaborator
- Ludwig-Maximilians - University of Munichcollaborator
Study Sites (7)
University of Bordeaux
Bordeaux, France
University of Munich
Munich, Bavaria, 81377, Germany
University of Marburg
Marburg, Germany
Radboud university medical center
Nijmegen, 6500 HB, Netherlands
Instituto de Medicina Molecular
Lisbon, 1649-028, Portugal
Lund University
Lund, SE-22185, Sweden
University College London
London, NW3 2PF, United Kingdom
Related Publications (2)
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.
PMID: 33738776DERIVEDBalzer-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.
PMID: 30396331DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 25, 2014
First Posted
January 7, 2015
Study Start
September 1, 2014
Primary Completion
March 31, 2019
Study Completion
March 31, 2019
Last Updated
April 28, 2021
Record last verified: 2021-04