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Effectiveness of occupational therapy in Parkinson’s disease: study protocol for a randomized controlled trial

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...

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Autores principales: Sturkenboom, Ingrid HWM, Graff, Maud J, Borm, George F, Adang, Eddy MM, Nijhuis-van der Sanden, Maria WG, Bloem, Bastiaan R, Munneke, Marten
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2013
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3599260/
https://www.ncbi.nlm.nih.gov/pubmed/23374761
http://dx.doi.org/10.1186/1745-6215-14-34
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author Sturkenboom, Ingrid HWM
Graff, Maud J
Borm, George F
Adang, Eddy MM
Nijhuis-van der Sanden, Maria WG
Bloem, Bastiaan R
Munneke, Marten
author_facet Sturkenboom, Ingrid HWM
Graff, Maud J
Borm, George F
Adang, Eddy MM
Nijhuis-van der Sanden, Maria WG
Bloem, Bastiaan R
Munneke, Marten
author_sort Sturkenboom, Ingrid HWM
collection PubMed
description 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/DESIGN: 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. DISCUSSION: 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. TRIAL REGISTRATION: Clinicaltrials.gov: NCT01336127.
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spelling pubmed-35992602013-03-17 Effectiveness of occupational therapy in Parkinson’s disease: study protocol for a randomized controlled trial Sturkenboom, Ingrid HWM Graff, Maud J Borm, George F Adang, Eddy MM Nijhuis-van der Sanden, Maria WG Bloem, Bastiaan R Munneke, Marten Trials Study Protocol 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/DESIGN: 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. DISCUSSION: 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. TRIAL REGISTRATION: Clinicaltrials.gov: NCT01336127. BioMed Central 2013-02-02 /pmc/articles/PMC3599260/ /pubmed/23374761 http://dx.doi.org/10.1186/1745-6215-14-34 Text en Copyright ©2013 Sturkenboom et al; licensee BioMed Central Ltd. http://creativecommons.org/licenses/by/2.0 This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Study Protocol
Sturkenboom, Ingrid HWM
Graff, Maud J
Borm, George F
Adang, Eddy MM
Nijhuis-van der Sanden, Maria WG
Bloem, Bastiaan R
Munneke, Marten
Effectiveness of occupational therapy in Parkinson’s disease: study protocol for a randomized controlled trial
title Effectiveness of occupational therapy in Parkinson’s disease: study protocol for a randomized controlled trial
title_full Effectiveness of occupational therapy in Parkinson’s disease: study protocol for a randomized controlled trial
title_fullStr Effectiveness of occupational therapy in Parkinson’s disease: study protocol for a randomized controlled trial
title_full_unstemmed Effectiveness of occupational therapy in Parkinson’s disease: study protocol for a randomized controlled trial
title_short Effectiveness of occupational therapy in Parkinson’s disease: study protocol for a randomized controlled trial
title_sort effectiveness of occupational therapy in parkinson’s disease: study protocol for a randomized controlled trial
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3599260/
https://www.ncbi.nlm.nih.gov/pubmed/23374761
http://dx.doi.org/10.1186/1745-6215-14-34
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