Long-Term Follow-Up of Participants in the Taking Charge After Stroke Randomized Controlled Trial

BACKGROUND: The Take Charge intervention-a conversation-based, community intervention to improve motivation, improved independence, and physical health 12 months after stroke in 2 randomized controlled trials with 572 participants. This article reports long-term outcomes for the 400 participants in the TaCAS study (Taking Charge After Stroke). METHODS: Follow-up study of a New Zealand multicenter, randomized, controlled, parallel-group trial. Outcomes were collected by postal questionnaire or telephone call. The TaCAS study recruited 400 participants discharged after stroke, randomized within 16 weeks to one of 3 groups: 1 session of the Take Charge intervention, 2 sessions 6 weeks apart, or no sessions (control). This study is of participants still alive and willing to answer a questionnaire 5 to 6 years after their index stroke, undertaken in 2022. The primary outcome was the Physical Component Summary of the Short Form 36, comparing the Take Charge intervention and control. Secondary outcomes were: Frenchay Activities Index; modified Rankin Scale (mRS); survival; and stroke recurrence. These outcomes were compared with those 12 months after stroke. Analysis was by ANOVA or logistic regression. RESULTS: Mortality data were available for all 400 participants, and functional data for 204/297 (69%) of survivors. The mean difference (95% CI) in Physical Component Summary between Take Charge and control groups was 2.8 (-0.8 to 6.5) units, P=0.12, and for independence (modified Rankin Scale score, 0-2) the odds ratio (95% CI) was 0.56 (0.28-1.16), P=0.11, both favoring Take Charge with similar point estimates to those after 12 months. Differences between Take Charge and control participants for Frenchay Activities Index scores, survival, and stroke recurrence were small and nonsignificant. CONCLUSIONS: The clinically significant improvements in physical health and independence for Take Charge participants, observed at 12 months, were sustained 5 to 6 years after stroke, but no longer statistically significant. REGISTRATION: URL: https://anzctr.org.au; Unique identifier: ACTRN12622000311752.