Abstract
BackgroundOccupational therapists may have an added value in the care of patients with Parkinson’s disease whose daily functioning is compromised, as well as for their immediate caregivers. Evidence for this added value is inconclusive due to a lack of rigorous studies. The aim of this trial is to evaluate the (cost) effectiveness of occupational therapy in improving daily functioning of patients with Parkinson’s disease.Methods/DesignA multicenter, assessor-blinded, two-armed randomized controlled clinical trial will be conducted, with evaluations at three and six months. One hundred ninety-two home-dwelling patients with Parkinson’s disease and with an occupational therapy indication will be assigned to the experimental group or to the control group (2:1). Patients and their caregivers in the experimental group will receive ten weeks of home-based occupational therapy according to recent Dutch guidelines. The intervention will be delivered by occupational therapists who have been specifically trained to treat patients according to these guidelines. Participants in the control group will not receive occupational therapy during the study period. The primary outcome for the patient is self-perceived daily functioning at three months, assessed with the Canadian Occupational Performance Measure. Secondary patient-related outcomes include: objective performance of daily activities, self-perceived satisfaction with performance in daily activities, participation, impact of fatigue, proactive coping skills, health-related quality of life, overall quality of life, health-related costs, and effectiveness at six months. All outcomes at the caregiver level will be secondary and will include self-perceived burden of care, objective burden of care, proactive coping skills, overall quality of life, and care-related costs. Effectiveness will be evaluated using a covariance analysis of the difference in outcome at three months. An economic evaluation from a societal perspective will be conducted, as well as a process evaluation.DiscussionThis is the first large-scale trial specifically evaluating occupational therapy in Parkinson’s disease. It is expected to generate important new information about the possible added value of occupational therapy on daily functioning of patients with Parkinson’s disease.Trial registrationClinicaltrials.gov: NCT01336127.
Highlights
Occupational therapists may have an added value in the care of patients with Parkinson’s disease whose daily functioning is compromised, as well as for their immediate caregivers
From 2006 to 2008 we developed guidelines for occupational therapy (OT) in Parkinson’s disease, under the auspices of the Dutch Association of Occupational Therapy with the aim to improve uniformity and quality of OT in Parkinson’s disease [18,19]
All outcomes at the caregiver level will be secondary and include self-perceived burden of care, objective burden of care, proactive coping skills, mood and overall quality of life. In both patients and caregivers resource use, productivity losses and other costs related to receiving support or providing care are assessed with a questionnaire for the economic evaluation
Summary
Current evidence for the effectiveness of OT in Parkinson’s disease is scarce and inconclusive. To cover the large geographical spread of participants in this multicenter trial, a relatively high number of trial therapists will be involved to deliver the intervention. This means that the average number of patients seen by each therapist within the trial is low. A strength of this trial is the presence of the national ParkinsonNet infrastructure within the Netherlands [23,24] This allows easier access to neurologists in the participating regional and university hospitals and their pool of patients. Another important and novel aspect in this study is that all other interventions are allowed to take place during the study.
Sign-in/Register to view highlights & summary Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
