Care for Late Stage Parkinsonism

Not Applicable

Completed

• Conditions: Late Stage Parkinson's Disease; Parkinson's Disease
• Interventions: Other: Specialist review

• Registration Number: NCT02333175
• Lead Sponsor: University College, London

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2014-09-25
• Study First Submitted QC: 2015-01-05
• Study First Posted: 2015-01-07
• Primary Completion: 2019-03-31
• Study Completion: 2019-03-31
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-27
• Last Update Posted: 2021-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 184

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Specialist review	Specialist review	Specialist review with individually tailored treatment strategies suggested by specialist

Primary Outcome Measures

Name	Time	Method
UPDRS-ADL part	6 months	Disability measure

Secondary Outcome Measures

Name	Time	Method
Zarit carer burden scale	6 months	Carer burden
Satisfaction with care Likert scale	6 months
MMSE	6 months	Mental health
NMSS	6 months	PD severity
PDQ-8 or DEMQoL proxy	6 months	Quality of Life
NPI	6 months	Mental health
UPDRS III	6 months	PD severity
Basic palliative care assessment	6 months	ESAS-PD
PD milestones	6 months	PD severity

Trial Locations

Locations (7)

Instituto de Medicina Molecular; 🇵🇹 Lisbon, Portugal

University of Munich; 🇩🇪 Munich, Bavaria, Germany

University of Bordeaux; 🇫🇷 Bordeaux, France

University of Marburg; 🇩🇪 Marburg, Germany

Radboud university medical center; 🇳🇱 Nijmegen, Netherlands

Lund University; 🇸🇪 Lund, Sweden

University College London; 🇬🇧 London, United Kingdom