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

Abstract

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.

Keywords: Care provision; Health-economic evaluation; Health-related quality of life; Late stage parkinsonism; Non-motor complications; Patient-reported outcomes; Quality of care.

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.

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