CLaSP: Care for Late Stage Parkinsonism

• Sponsor: University College, London (Other)
• Overall Status: Completed
• CT.gov ID: NCT02333175
• Collaborator: Philipps University Marburg Medical Center (Other), Instituto de Medicina Molecular João Lobo Antunes (Other), University Medical Center Nijmegen (Other), Lund University (Other), University Hospital, Bordeaux (Other), Ludwig-Maximilians - University of Munich (Other)
• Enrollment: 184
• Locations: 7
• Arms: 2
• Actual Duration (Months): 54.9
• Patients Per Site: 26.3
• Patients Per Site Per Month: 0.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Parkinson's Disease; Late Stage Parkinson's Disease	Other: Specialist review	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 184 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Care for Late Stage Parkinsonism
• Actual Study Start Date: Sep 1, 2014
• Actual Primary Completion Date: Mar 31, 2019
• Actual Study Completion Date: Mar 31, 2019

Arms and Interventions

Arm	Intervention/Treatment
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
No Intervention: Care as usual Care as usual

Outcome Measures

Primary Outcome Measures

1. UPDRS-ADL part [6 months]

   Disability measure

Secondary Outcome Measures

1. PDQ-8 or DEMQoL proxy [6 months]

   Quality of Life

2. Zarit carer burden scale [6 months]

   Carer burden

3. Satisfaction with care Likert scale [6 months]

4. MMSE [6 months]

   Mental health

5. NPI [6 months]

   Mental health

6. UPDRS III [6 months]

   PD severity

7. NMSS [6 months]

   PD severity

8. PD milestones [6 months]

   PD severity

9. Basic palliative care assessment [6 months]

   ESAS-PD

Eligibility Criteria

Criteria

• Ages Eligible for Study: 1 Year to 100 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Bordeaux	Bordeaux		France
2	University of Munich	Munich	Bavaria	Germany	81377
3	University of Marburg	Marburg		Germany
4	Radboud university medical center	Nijmegen		Netherlands	6500 HB
5	Instituto de Medicina Molecular	Lisbon		Portugal	1649-028
6	Lund University	Lund		Sweden	SE-22185
7	University College London	London		United Kingdom	NW3 2PF

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University College, London
• ClinicalTrials.gov Identifier: NCT02333175
• Other Study ID Numbers: 14/0040
• First Posted: Jan 7, 2015
• Last Update Posted: Apr 28, 2021
• Last Verified: Apr 1, 2021

• Keywords provided by University College, London: Parkinson's disease, Late stage
• Additional relevant MeSH terms: Parkinson Disease; Parkinsonian Disorders

Study Results

No Results Posted as of Apr 28, 2021