Parkinson's DiseaseCLaSPNCT02333175
Care for Late Stage Parkinsonism
A study testing Specialist review in people with Parkinson's Disease and Late Stage Parkinson's Disease, run by University College, London at 7 sites in 6 countries.
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. Read more about this study
- Who is it for?
- Ages 1 year to 100 years
- Conditions the study is for
- Parkinson's Disease, Late Stage Parkinson's Disease
- What is being tested?
- Specialist review
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 184 participants
- Where
- 7 sitesin 6 countries
- Study dates
- Sep 2014to 31 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Hoehn and Yahr stage (HY) IV or V in the "On"-state
- Disease duration of at least 7 years
Who cannot join
- Symptomatic Parkinsonism
Trial locations and contacts
7 sites in 6 countries.
7 sites in 6 countries
Germany2 sites
University of Marburg
Marburg
University of Munich
Munich, Bavaria, 81377
About this study
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.
- Being tested
- Specialist review
- Keywords
- Parkinson's disease, Late stage
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Specialist reviewOther
Specialist review with individually tailored treatment strategies suggested by specialist
| Study group | Role | What they receive |
|---|---|---|
| Specialist review | Active comparator | Specialist review with individually tailored treatment strategies suggested by specialist Receives: Other: Specialist review |
| Care as usual | No intervention | Care as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
UPDRS-ADL part
Disability measure
Measured: 6 months
Secondary outcomes (9)
PDQ-8 or DEMQoL proxy
Quality of Life
Measured: 6 months
Zarit carer burden scale
Carer burden
Measured: 6 months
Satisfaction with care Likert scale
Measured: 6 months
MMSE
Mental health
Measured: 6 months
NPI
Mental health
Measured: 6 months
UPDRS III
PD severity
Measured: 6 months
NMSS
PD severity
Measured: 6 months
PD milestones
PD severity
Measured: 6 months
Basic palliative care assessment
ESAS-PD
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2015 (estimated)
- Study startSep 2014
- Primary completion31 Mar 2019
- Study completion31 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 184 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Collaborators
- Philipps University Marburg, Instituto de Medicina Molecular João Lobo Antunes, University Medical Center Nijmegen, Lund University, University Hospital, Bordeaux, Ludwig-Maximilians - University of Munich
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02333175
- Sponsor's protocol ID
- 14/0040
- Acronym
- CLaSP
- Status last verified
- Apr 2021
- First submitted
- 25 Sep 2014
- Last updated
- 28 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Kruse C, Lipinski A, Verheyen M, Balzer-Geldsetzer M, Wittenberg M, Lorenzl S, Richinger C, Schmotz C, Tonges L, Woitalla D, Klebe S, Bloem BR, Hommel A, Meissner WG, Laurens B, Boraud T, Foubert-Samier A, Vergnet S, Tison F, Costa N, Odin P, Rosqvist K, Norlin JM, Hjalte F, Schrag A, Dodel R. Care of Late-Stage Parkinsonism: Resource Utilization of the Disease in Five European Countries. Mov Disord. 2024 Mar;39(3):571-584. doi: 10.1002/mds.29718. Epub 2024 Feb 29.
PubMed 38425158Kruse 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.
PubMed 33738776Balzer-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.
PubMed 30396331
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Care for Late Stage Parkinsonism
- ClinicalTrials.gov ID
- NCT02333175
- Acronym / sponsor ID
- CLaSP / 14/0040
- Keywords
- Parkinson's disease, Late stage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 184 participants (actual)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Collaborators
- Philipps University Marburg, Instituto de Medicina Molecular João Lobo Antunes, University Medical Center Nijmegen, Lund University, University Hospital, Bordeaux, Ludwig-Maximilians - University of Munich
- Study start
- Sep 2014 (actual)
- Primary completion
- 31 Mar 2019 (actual)
- Study completion
- 31 Mar 2019 (actual)
- First posted
- 7 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Specialist review | Active comparator | Other: Specialist reviewSpecialist review with individually tailored treatment strategies suggested by specialist |
| Care as usual | No intervention | –Care as usual |
Who may qualify
- Ages
- 1 year to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Hoehn and Yahr stage (HY) IV or V in the "On"-state
- Disease duration of at least 7 years
Key exclusion criteria (1 listed)
- Symptomatic Parkinsonism
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Specialist reviewSpecialist review with individually tailored treatment strategies suggested by specialist | Other | Specialist review |
Primary outcome
UPDRS-ADL part
Time frame: 6 months
Disability measure
9 secondary outcomes
PDQ-8 or DEMQoL proxy
Time frame: 6 months
Zarit carer burden scale
Time frame: 6 months
Satisfaction with care Likert scale
Time frame: 6 months
MMSE
Time frame: 6 months
NPI
Time frame: 6 months
UPDRS III
Time frame: 6 months
NMSS
Time frame: 6 months
PD milestones
Time frame: 6 months
Basic palliative care assessment
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2021.
- Derived from this study: PubMed 38425158Kruse C, Lipinski A, Verheyen M, Balzer-Geldsetzer M, Wittenberg M, Lorenzl S, Richinger C, Schmotz C, Tonges L, Woitalla D, Klebe S, Bloem BR, Hommel A, Meissner WG, Laurens B, Boraud T, Foubert-Samier A, Vergnet S, Tison F, Costa N, Odin P, Rosqvist K, Norlin JM, Hjalte F, Schrag A, Dodel R. Care of Late-Stage Parkinsonism: Resource Utilization of the Disease in Five European Countries. Mov Disord. 2024 Mar;39(3):571-584. doi: 10.1002/mds.29718. Epub 2024 Feb 29.
- Derived from this study: PubMed 33738776Kruse 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.
- Derived from this study: PubMed 30396331Balzer-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Specialist review in people with Parkinson's Disease and Late Stage Parkinson's Disease, run by University College, London at 7 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Germany, France, Netherlands, Portugal, Sweden and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
UPDRS-ADL part (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02333175, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2021.