Outcomes of the My Therapy self-management program in people admitted for rehabilitation: A stepped wedge cluster randomized clinical trial

Background: Self-management programs can increase the time spent on prescribed therapeutic exercises and activities in rehabilitation inpatients, which has been associated with better functional outcomes and shorter hospital stays. Objectives: To determine whether implementation of a self-management program (‘My Therapy’) improves functional independence relative to routine care in people admitted for physical rehabilitation. Methods: This stepped wedge, cluster randomized trial was conducted over 54 weeks (9 periods of 6-week duration, April 2021 - April 2022) across 9 clusters (general rehabilitation wards) within 4 hospitals (Victoria, Australia). We included all adults (≥18 years) admitted for rehabilitation to participating wards. The intervention included routine care plus ‘My Therapy’, comprising a sub-set of exercises and activities from supervised sessions which could be performed safely, without supervision or assistance. The primary outcomes were the proportion of participants achieving a minimal clinically important difference (MCID) in the Functional Independence Measure, (FIM™) and change in total FIM™ score from admission to discharge. Results: 2550 participants (62 % women) were recruited (control: n = 1458, intervention: n = 1092), with mean (SD) age 77 (13) years and 37 % orthopedic diagnosis. Under intervention conditions, participants reported a mean (SD) of 29 (21) minutes/day of self-directed therapy, compared to 4 (SD 14) minutes/day, under control conditions. There was no evidence of a difference between control and intervention conditions in the odds of achieving an MCID in FIM™ (adjusted odds ratio 0.93, 95 % CI 0.65 to 1.31), or in the change in FIM™ score (adjusted mean difference: -0.27 units, 95 % CI -2.67 to 2.13). Conclusions: My Therapy was delivered safely to a large, diverse sample of participants admitted for rehabilitation, with an increase in daily rehabilitation dosage. However, given the lack of difference in functional improvement with participation in My Therapy, self-management programs may need to be supplemented with other strategies to improve function in people admitted for rehabilitation. Trial registration: Australian New Zealand Clinical Trials Registry (ACTRN12621000313831), https://www.anzctr.org.au/