Care for Late Stage Parkinsonism (CLaSP)

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.

Study Overview

• Status: Completed
• Conditions: Parkinson's Disease; Late Stage Parkinson's Disease
• Intervention / Treatment: Other: Specialist review

• Study Type: Interventional
• Enrollment (Actual): 184
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Bordeaux, France
    • University of Bordeaux
• Germany
  • Marburg, Germany
    • University of Marburg
  • Bavaria
    • Munich, Bavaria, Germany, 81377
      • University of Munich
• Netherlands
  • Nijmegen, Netherlands, 6500 HB
    • Radboud University Medical Center
• Portugal
  • Lisbon, Portugal, 1649-028
    • Instituto de Medicina Molecular
• Sweden
  • Lund, Sweden, SE-22185
    • Lund University
• United Kingdom
  • London, United Kingdom, NW3 2PF
    • University College London

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 100 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Care as usual
Active Comparator: Specialist review; Specialist review with individually tailored treatment strategies suggested by specialist	Other: Specialist review; Specialist review with individually tailored treatment strategies suggested by specialist

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University College, London
• Collaborators: Lund University; University Hospital, Bordeaux; Ludwig-Maximilians - University of Munich; Philipps University Marburg Medical Center; University Medical Center Nijmegen; Instituto de Medicina Molecular João Lobo Antunes

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2014
• Primary Completion (Actual): March 31, 2019
• Study Completion (Actual): March 31, 2019

Study Registration Dates

• First Submitted: September 25, 2014
• First Submitted That Met QC Criteria: January 5, 2015
• First Posted (Estimate): January 7, 2015

Study Record Updates

• Last Update Posted (Actual): April 28, 2021
• Last Update Submitted That Met QC Criteria: April 27, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Parkinson's disease, Late stage
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease; Parkinsonian Disorders
• Other Study ID Numbers: 14/0040