Care for Late Stage Parkinsonism

Parkinson's Disease Clinical Trial

— CLaSP  

Official title:

Care for Late Stage Parkinsonism

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02333175
• Other study ID #: 14/0040
• Status: Completed
• Phase: N/A
• Start date: September 2014
• Est. completion date: March 31, 2019

Study information

• Verified date: April 2021
• Source: University College, London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 184
• Est. completion date: March 31, 2019
• Est. primary completion date: March 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Late Stage Parkinson's Disease
• Parkinson Disease
• Parkinson's Disease
• Parkinsonian Disorders

Intervention

Other:
• Specialist review
Specialist review with individually tailored treatment strategies suggested by specialist

Locations

Country	Name	City	State
France	University of Bordeaux	Bordeaux
Germany	University of Marburg	Marburg
Germany	University of Munich	Munich	Bavaria
Netherlands	Radboud university medical center	Nijmegen
Portugal	Instituto de Medicina Molecular	Lisbon
Sweden	Lund University	Lund
United Kingdom	University College London	London

Sponsors (7)

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

Countries where clinical trial is conducted

France,  Germany,  Netherlands,  Portugal,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	UPDRS-ADL part	Disability measure	6 months
Secondary	PDQ-8 or DEMQoL proxy	Quality of Life	6 months
Secondary	Zarit carer burden scale	Carer burden	6 months
Secondary	Satisfaction with care Likert scale		6 months
Secondary	MMSE	Mental health	6 months
Secondary	NPI	Mental health	6 months
Secondary	UPDRS III	PD severity	6 months
Secondary	NMSS	PD severity	6 months
Secondary	PD milestones	PD severity	6 months
Secondary	Basic palliative care assessment	ESAS-PD	6 months