<p>Background and aims: Stroke is the third leading cause of disability worldwide. Despite the recent development of hyper-acute therapies for stroke, outcomes for people with stroke and types of rehabilitation interventions have remained unchanged. Rehabilitation in New Zealand is largely therapy-based and uses goal setting as a main component, but evidence for effectiveness of these methods is weak. Attempts to enhance the effects of rehabilitation using a stroke liaison officer or a caregiver to lead rehabilitation at home have had no effect on outcomes. However, self-management interventions have shown some promise. The Take Charge session is a novel, community-based, self-management intervention, which was shown to significantly improve both independence and health-related quality of life at 12 months following stroke in Māori and Pacific New Zealanders. We formalised the components of the Take Charge session, based upon Self Determination Theory and qualitative research about the importance of Taking Charge in recovery. This allowed us to retest the intervention in a different population of people with stroke. We hypothesised that: (1) the beneficial effect of the Take Charge session would be reproducible in a larger cohort of non-Māori, non-Pacific people with stroke, and (2) that two Take Charge sessions would have a greater positive effect on health-related quality of life than one alone. Methods: We randomised 400 people within 16 weeks of acute stroke who had been discharged to community living at seven centres in New Zealand to either a single Take Charge session (TCS 1, n = 132), two Take Charge sessions (TCS 2, n = 138), or a control intervention (n = 130). The primary outcome was the Physical Component Summary score (PCS) of the Short Form 36 (SF-36) at 12 months following index stroke, comparing any Take Charge session exposure to control. Secondary outcomes included the PCS of the Short Form 12 (SF-12) at six months, participation measured by the Frenchay Activities Index at six and 12 months, and activities measured by the Barthel Index at six and 12 months. Outcome measures were performed by an assessor masked to allocation. Results: At 12 months following stroke, participants in either of the Take Charge groups (TCS 1 + TCS 2) scored 2.9 (95% CI 0.95 to 4.9, p = 0.004) points higher (better) than control on the SF-36 PCS. This difference was statistically and clinically significant. The effect size remained significant when we adjusted for pre-specified baseline variables, including age, gender, and baseline stroke severity. Furthermore, SF-12 PCS at six months showed improvement in similar direction and effect size, and improvement in participation was statistically significant at 12 months. There was a positive dose effect with each exposure to the Take Charge session predicting a 1.9 (95% CI 0.8 to 3.1, p < 0.001) point increase in the 12-month SF-36 PCS. Subsequently, we conducted an individual patient meta-analysis of the Take Charge session, pooling data with the initial Māori and Pacific Stroke Study. The pooled effect of any exposure to the Take Charge session was 3.74 (95% CI 1.96 to 5.51) points greater than control. Conclusion: The Take Charge session – a simple, self-management intervention, improved healthrelated quality of life and participation at 12 months. This thesis provides evidence for implementing such an intervention into routine, post-stroke care, to improve the quality of life of people with stroke in the long term.</p>
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