EVALUATING THE FEASIBILITY OF THE PACKER MANAGING FATIGUE PROGRAM IN PARKINSON’S DISEASE: A MIXED METHOD PILOT RANDOMIZED CONTROLLED TRIAL

Abstract

Management of fatigue has been identified as an unmet need in Parkinson’s disease (PD) care. To address this gap, this study evaluated the feasibility of conducting a future full-scale randomized controlled trial (RCT) of the individual version of the Packer Managing Fatigue program delivered via videoconference. The study had two primary objectives: 1) to explore the perspectives of PwPD on the feasibility of the Packer Managing Fatigue program; and 2) to evaluate the feasibility of the proposed research protocol and outcome measures for future RCTs. This pilot, mixed-method RCT employed an assessor-blinded, two-arm design. Participants were recruited from Nova Scotia and Ontario and had to meet specific inclusion criteria: self-reported PD diagnosis, severe fatigue, English proficiency, and internet access. A total of 25 participants completed baseline measures. Standardized outcome measures and non-standardized feasibility questionnaires were used to collect quantitative data. Participants in the intervention group, were also invited to take part in a qualitative interview or focus group. Triangulation was carried out during the interpretation phase. Five themes emerged: (1) program is helpful, (2) strengths of the program, (3) areas for improvement, (4) individual online delivery feasible and (5) more support from OT would be helpful. Quantitative findings confirmed feasibility with high ratings on questionnaires and confidence in using learned strategies. Quantitative findings confirmed the feasibility of the program as well. The mixed-design ANOVA demonstrated trends toward significant improvement in occupational satisfaction and small-moderate effect sizes for occupational performance, occupational balance, and reduced motivation and physical aspects of fatigue. In conclusion, this feasibility study demonstrated the potential application of the Packer Managing Fatigue Program among PWPD. The findings support the need for future full-scale RCTs to rigorously evaluate the effectiveness of the program. Additionally, this study provided valuable insights into patient perspectives and the feasibility of outcome measures for use in future RCTs. This research makes a significant contribution to the development of fatigue interventions for PD fatigue and informs future investigations.