Study protocol: Care of Late-Stage Parkinsonism (CLaSP): A longitudinal cohort study

1. BMC Neurol. 2018 Nov 5;18(1):185. doi: 10.1186/s12883-018-1184-3.

Study protocol: Care of Late-Stage Parkinsonism (CLaSP): a longitudinal cohort
study.

Balzer-Geldsetzer M(1)(2), Ferreira J(3), Odin P(4), Bloem BR(5), Meissner
WG(6)(7), Lorenzl S(8)(9), Wittenberg M(10), Dodel R(1)(2), Schrag A(11).

Author information:
(1)Department of Neurology, Philipps-University Marburg, Marburg, Germany.
(2)Department of Geriatric Medicine, University Hospital Essen, Essen, Germany.
(3)Instituto de Medicina Molecular Universidad di Lisboa, Lisboa, Portugal.
(4)Department of Neurology, Lund University Hospital, Lund, Sweden.
(5)Donders Institute for Brain, Cognition and Behaviour, Department of
Neurology, Radboud University Medical Center, Nijmegen, The Netherlands.
(6)Service de Neurologie, CHU de Bordeaux, 33000, Bordeaux, France.
(7)Institut des Maladies Neurodégénératives, University de Bordeaux, UMR 5293,
33000, Bordeaux, France.
(8)Interdisziplinäres Zentrum für Palliativmedizin und Klinik für Neurologie
Universität München – Klinikum Großhadern, Munich, Germany.
(9)Institute of Nursing Science and -Practice, Salzburg, Austria.
(10)Coordinating Centre for Clinical Trials (KKS), Philipps-University Marburg,
Marburg, Germany.
(11)UCL Institute of Neurology, University College London, Royal Free Campus,
Rowland Hill street, NW3 2PF, London, UK. .

BACKGROUND: Parkinson’s disease (PD) is a chronic progressive disorder leading
to increasing disability. While the symptoms and needs of patients in the early
stages of their disease are well characterized, little information is available
on patients in the late stage of the disease.
METHODS/DESIGN: The Care of Late-Stage Parkinsonism (CLaSP) study is a
longitudinal, multicenter, prospective cohort study to assess the needs and
provision of care for patients with late stage Parkinsonism and their carers in
six European countries (UK, France, Germany, Netherlands, Portugal, Sweden). In
addition, it will compare the effectiveness of different health and social care
systems. Patients with Parkinsonism with Hoehn and Yahr stage ≥IV in the
« On »-state or Schwab and England stage 50% or less are evaluated at baseline and
three follow-up time-points. Standardised questionnaires and tests are applied
for detailed clinical, neuropsychological, behavioural and health-economic
assessments. A qualitative study explores the health care needs and experiences
of patients and carers, and an interventional sub-study evaluates the impact of
specialist recommendations on their outcomes.
DISCUSSION: Through the combined assessment of a range of quantitative measures
and qualitative assessments of patients with late stage parkinsonism, this study
will provide for the first time comprehensive and in-depth information on the
clinical presentation, needs and health care provision in this population in
Europe, and lay the foundation for improved outcomes in these patients.
TRIAL REGISTRATION: The protocol was registered at ClinicalTrials.gov as
NCT02333175 on 07/01/2015.

DOI: 10.1186/s12883-018-1184-3
PMCID: PMC6217790
PMID: 30396331 [Indexed for MEDLINE]

Conflict of interest statement: ETHICS APPROVAL AND CONSENT TO PARTICIPATE: All
study sites received approval of their local ethics committee before study
start; all patients gave their written informed consent before study
participation. The CLaSP study is being conducted in compliance with the
Helsinki Declaration [35], i.e. detailed oral and written information is given
to the patients and their informant to ensure that the patient fully understands
potential risks and benefits of the study. The study protocol was approved by
the local ethics committees of all participating study sites (London:Camden and
Islington NRES Committee 14/LO/0612, Bordeaux: South West and Overseas
Protection Committee III (South West and Overseas Protection Committee).
2014-A01501–46, Lisbon:Centro Hospitalar Lisboa Norte, DIRCLN-19SET2014–275,
Lund: EPN Regionala etikprovningsnamnden: Lund (EPN Regional Ethics Name: Lund).
JPND NC 559–002, Marburg: Ethik-Kommission bei der Landesarztekammer Hessen
(Ethics Commission at the State Medical Association Hesse). MC 309/2014, Munich:
Ethikkommission bei der LMU Munchen (Ethics committee at the LMU Munchen).
193–14, Nijmegen: Radboud universitair medisch centrum, Concernstaf Kwaliteit en
Veiligheid, Commissie Mensgebonden Onderzoek Regio Arnhem-Nijmegen (Radboud
university medical center,Group staff Quality and Safety Human Research
Committee, Arnhem-Nijmegen region). DJ/CMO300). INFORMED CONSENT: Participants
(patients and their caregivers) are included in the study after giving their
written informed consent. In case the patient lacks capacity to give consent to
the study due to severe cognitive impairment, the decision on study
participation is made by a legal guardian or consultee, depending on the ethical
and legal requirements at each site. All participants (patients and caregivers)
can withdraw from the study at any point in time without any negative
implications. CONSENT FOR PUBLICATION: All authors have read the final
manuscript and consented publication. COMPETING INTERESTS: The authors declare
that they have no competing interests. PUBLISHER’S NOTE: Springer Nature remains
neutral with regard to jurisdictional claims in published maps and institutional
affiliations.

Auteurs Bordeaux Neurocampus