title: Effectiveness of occupational therapy in Parkinson's disease: study protocol for a randomized controlled trial.
abstract: BACKGROUND
  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. 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
  A 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.
  
  
  CONCLUSIONS
  This 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.
  
  
  BACKGROUND
  Clinicaltrials.gov: NCT01336127.
authors: Nijmegen Centre of Evidence Based Practice, Department of Rehabilitation-Occupational Therapy (898), Radboud University Nijmegen Medical Centre, Reinier Postlaan 2, 6525GC, PO Box 9101 6500HB, Nijmegen, The Netherlands. i.sturkenboom@reval.umcn.nl
authors: Ingrid H W M
authors: IH
authors: Sturkenboom
authors: Maud J
authors: MJ
authors: Graff
authors: George F
authors: GF
authors: Borm
authors: Eddy M M
authors: EM
authors: Adang
authors: Maria W G
authors: MW
authors: Nijhuis-van der Sanden
authors: Bastiaan R
authors: BR
authors: Bloem
authors: Marten
authors: M
authors: Munneke
mesh_terms: D000203:Activities of Daily Living; D000223:Adaptation, Psychological; D000704:Analysis of Variance; D017028:Caregivers / Q000523:psychology; D002985:Clinical Protocols; D017281:Cost of Illness; D003362:Cost-Benefit Analysis; D017048:Health Care Costs; D006304:Health Status; D006801:Humans; D057187:Independent Living; D008603:Mental Health; D018803:Models, Economic; D009426:Netherlands; D009788:Occupational Therapy / Q000191:economics; D010300:Parkinson Disease / Q000175:diagnosis / Q000191:economics / Q000523:psychology / Q000628:therapy*; D017060:Patient Satisfaction; D011788:Quality of Life; D012107:Research Design; D013997:Time Factors; D016896:Treatment Outcome
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