Health-Related Quality of Life in Parkinson's Disease: A Randomized Controlled Trial
Authors: Tickle-Degnen L, Ellis T, Saint-Hilaire MH, Thomas CA and Wagenaar RC (2010); Movement Disorders, Vol. 25, No. 2, 2010, pp. 194–204
ABSTRACT
The purpose of this randomized controlled trial (RCT) was to determine whether increasing hours of self-management rehabilitation had increasing benefits for health-related quality of life (HRQOL) in Parkinson’s disease beyond best medical treatment, whether effects persisted at 2 and 6 months of follow-up, and whether targeted compared with nontargeted HRQOL domains responded more to rehabilitation.
Participants on best medication therapy were randomly assigned to one of three conditions for 6 weeks intervention: 0 hours of rehabilitation; 18 hours of clinic group rehabilitation plus 9 hours of attention control social sessions; and 27 hours of rehabilitation, with 18 in clinic group rehabilitation and 9 hours of rehabilitation designed to transfer clinic training into home and community routines.
Results (N = 116) showed that at 6 weeks, there was a beneficial effect of increased rehabilitation hours on HRQOL measured with the Parkinson’s Disease Questionnaire-39 (PDQ-39) summary index (F(1,112) = 6.48, h = 0.23, CI = 0.05–0.40, P = 0.01). Benefits persisted at follow-up. The difference between 18 and 27 hours was not significant. Clinically relevant improvement occurred at a greater rate for 18 and 27 hours (54% improved) than for 0 hours (18% improved), a significant 36% difference in rates (95% CI = 20–52% difference). Effects were largest in two targeted domains: communication and mobility. More concerns with mobility and activities of daily living at baseline predicted more benefit from rehabilitation.
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Review contributed by Ana Aragon, COT, Associate Senior Lecturer, Leeds Metropolitan University, Bath, UK
This study gives empirical weight to the approach employed by therapists delivering Parkinson’s specific rehabilitation and self-management education. A canon of research points towards techniques to improve quality of life for people with Parkinson’s, by providing tools to address the common gaps in function that persist despite use of best anti-Parkinson’s medications. Robust research to evaluate such interventions delivered to people with Parkinson’s by physiotherapists, occupational therapists and speech and language therapists is, however, scarce, making Tickle-Degnen and colleagues’ study particularly interesting.
Subjects (N=117) for this RCT were recruited via a Movement Disorders Medical Centre and local support groups in Boston Massachusetts USA, in 9 waves - between 2003 and 2005. Details are provided on funding, approval, inclusion and exclusion criteria, accrual and attrition rates, randomization, adverse events (N=0), and comprehensive baseline characteristics of participants with mild-to-moderate Parkinson's disease - with Hoehn & Yahr (“on” state) scores - between 2 and 3.
Participants were assessed in the “on” state, which is an important consideration, when examining function in people with Parkinson's disease using activity based interventions and assessments. This RCT pragmatically navigates many obstacles of evaluating a clearly outlined, bespoke, evidence-based rehabilitative intervention, delivered by a physiotherapist, an occupational therapist and a speech and language therapist, at 2 intensities compared to best medical care.
Capturing the diverse effects of individually-tailored multidisciplinary interventions is challenging in a RCT context, where participants set their own goals for rehabilitation, to reflect usual clinical practice. Improvements in HRQOL were, however, measured by blinded assessors, using the PDQ-39, other measures of HRQOL, health status, self-reported symptom severity, depression, optimism and satisfaction with healthcare. The authors acknowledge the difficulty of blinding assessors and participants in action-based interventions and in this study 14% revealed group assignments to assessors, although, following analysis, this was not considered significant. On reflection, the authors note their study may have been underpowered to assess the 2 different intervention intensities, yet when undertaken, this was a large scale trial compared to similar studies.
The authors furthermore suggest the ‘social sessions’ given to the rehabilitation, plus 9 hours of ‘attention control’ group, may have been unintentionally therapeutic and thus diluted the effect of the additional individual therapy in the community for the enhanced rehabilitation condition. Lack of attention in the control condition could also perhaps confound results, but few try to deliver ‘sham rehabilitation’, so use of a ‘control group’ receiving only standard medical care is common in active intervention studies. Medium strength improvements were made by the intervention groups, compared to the best medical care group. Diminishing gains made by both intervention group participants persisted at the 6 month follow-up, suggesting the need for further ‘short courses’ of intervention - perhaps once or twice annually. A reasonable carryover for interventions addressing a chronic degenerative condition which far out-live any single dose or short course of pharmacological Parkinson’s treatment!
The Specialist Parkinson's Integrated Rehabilitation Team Trial (SPIRITT) study is a multidisciplinary community-based RCT that builds on a previous clinic based rehabilitation programme, delivered in Surrey, England. Recruitment is due to end in December 2012, so we can look forward to preliminary results in 2013 to hopefully add further endorsement to Tickle-Degnen and colleagues' encouraging findings. View the SPIRiTT protocol via this link: www.trialsjournal.com/content/12/1/250
About Ana Aragon, COT
Ana Aragon is an Independent occupational therapist & Associate Senior Lecturer with a special interest in Parkinson’s. Ana qualified as an OT in 1989. Her special interest in ‘Cognitive and Sensory Rehabilitation Strategies for people with Parkinson's’ was initially inspired by the work of The Kingston Centre, Melbourne Australia, which she was fortunate enough to visit early in 1998. After over 11 years working in a multi-disciplinary specialist service for people with Parkinson's and related movement disorders, Ana now leads a part-time Online Master's degree in Parkinson's disease Practice for Leeds Metropolitan University. She also supports Parkinson’s UK and the European Parkinson’s Disease Association on various projects.
Ana has contributed to: 4 books (with another contribution in press), 2 national Parkinson's disease guideline development projects (NICE 2006 & COT / Parkinson’s UK 2010) and various information sheets about managing functional symptoms of the condition. Involvement in Occupational Therapy for people with Parkinson's research projects includes membership of the OT steering group for PD REHAB coordinated by University of Birmingham, and undertaking an online survey of people with Parkinson’s living in 4 European countries. She presents at training events and conferences around the UK from time to time. ... and loves bees!
You may reach Ana Aragon by email at: a.aragon@leedsmet.ac.uk