Efficacy and Feasibility of the CO-OP Approach in Parkinson's Disease: RCT Study Protocol.

Background. Parkinson's disease (PD) leads to cognitive dysfunction which limits participation and occupational performance. Cognitive Orientation to Daily Occupational Performance (CO-OP) approach is effective in other adult neurological populations and warrants investigation in PD. Purpose. To describe a study protocol evaluating the preliminary efficacy and feasibility of CO-OP approach in PD. Method. A randomised controlled trial (RCT) with adults with PD was assigned to either: CO-OP training-intensive (CO-OP-I, 20 sessions) or waitlist control (WLC) followed by CO-OP-standard (CO-OP-S, 10 sessions). Outcomes. Occupational performance and satisfaction of adults with PD in chosen goals. Measures will be obtained at baseline, post-intervention, and 3-month follow-up. Implications. As the first RCT focused on CO-OP in PD, this trial will provide evidence for the potential of this approach in PD and lay the groundwork for future large-scale trials. Trial Registration. Australian New Zealand Clinical Trials registry, ACTRN12621001483842. Registered November 1, 2021; retrospectively registered 3 months after commencement.