Occupational Therapy to Optimise Independence in Parkinson's Disease: The Designing and Recording of a Randomised Controlled Trial Intervention
Meek, Charmaine, Morgan, Eric, Walker, Marion F., Furmston, Alexandra, Aragon, Ana, Birleson, Angela, Kelly, Vicky, Clarke, Carl E., Sackley, Catherine M., British Journal of Occupational Therapy
The clinical management of Parkinson's disease (PD) consists predominantly of pharmacological therapy However, even with optimal medical treatment in place, disability can still persist and progress (Deane et al 2001). In particular, PD has a profound impact on a person's ability to carry out self-care and activities of daily living (ADL) (Birleson 1998), resulting in increased dependence. For this reason, non-pharmacological treatments, such as occupational therapy, are often employed as an adjunct to traditional medical management (Deane and Playford 2003).
The inclusion of occupational therapy in the management of PD is supported by anecdotal evidence from patients and health care professionals (Deane et al 2002) and national guidelines (National Collaborating Centre for Chronic Conditions 2006). Despite this, supportive trial evidence is fairly limited, with a systematic review by Deane et al (2001) uncovering only two small randomised controlled trials (RCTs) and concluding that there was insufficient evidence to support or refute the efficacy of occupational therapy in PD. These authors recommended that large, methodologically sound, RCTs should be carried out. Consequently, in 2005 a phase II pragmatic RCT began to evaluate the acceptability of occupational therapy as practised in the United Kingdom (UK) and to provide data to underpin a sample size calculation for the large phase III RCT required in this area. This was the Parkinson's Disease Occupational Therapy trial (PDOT) (Clarke et al 2009).
To ensure reproducibility, the reporting of an RCT should include 'precise details of the interventions intended for each group, and how and when they were actually administered' (CONSORT statement, Item 4, Moher et al 2001, p1192). Therefore, in an attempt to fulfil this requirement, the PDOT team developed the intervention using a clear stepped approach and then adopted an intervention log to be used throughout the trial in order to capture the actual treatment delivered.
Following the recommendations of Deane (2006), this paper aims to detail the PDOT intervention through a designated intervention paper. More specifically, it aims to:
1. Provide a brief overview of the PDOT trial (Clarke et al 2009)
2. Describe the process undertaken to design the therapeutic intervention (including providing an outline of the evidence base available at the time of the trial)
3. Present the intervention log used within the PDOT trial
4. Report and discuss the information captured by the intervention log
5. Discuss the limitations of the log and the measures taken to improve the tool for the follow-on trial to PDOT, the phase III RCT PD REHAB.
Overview of the PDOT trial
PDOT was a phase II pragmatic RCT investigating an occupational therapy intervention designed to optimise functional independence in people with PD. The trial aimed to assess accrual and withdrawal rates, to ascertain the feasibility and acceptability of the intervention and outcome measures, and to inform a sample size calculation for a phase III RCT. As a pilot study, it was not powered to assess the effectiveness of the intervention delivered.
Briefly, patients with idiopathic PD (Hoehn and Yahr stages II to IV) exhibiting difficulties with ADL, who had not received occupational therapy within the previous 12 months, were recruited from neurology and older people's clinics within the West Midlands. Patients were randomised at the level of the individual and stratified by level of ADL impairment, as recorded by the Barthel ADL Index (Mahoney and Barthel 1965). Participants were randomised to receive either an individualised, community-delivered occupational therapy intervention or standard care with no intervention (this group received occupational therapy immediately following their final assessment at the end of the trial). For the purposes of this paper, only the intervention group is discussed. …