Long term follow-up of participants in the Taking Charge after Stroke randomised controlled trial

BackgroundThe Take Charge intervention - a conversation-based, community intervention to improve motivation, improved independence and physical health 12 months after stroke in two randomised controlled trials with 572 participants. This paper reports long term outcomes for the 400 participants in the Taking Charge After Stroke (TaCAS) study. MethodA follow-up study, of a multicentre, randomised, controlled, parallel-group trial. Outcome measures were collected by postal questionnaire or by telephone call. The TaCAS study recruited 400 participants discharged after stroke, randomised within 16 weeks to one of three groups: one session of the Take Charge intervention, two sessions six weeks apart or no sessions (control). This study is of participants still alive and willing to answer a questionnaire between 5 and 6 years after their index stroke. The primary outcome was the Physical Component Summary (PCS) of the Short Form 36. Secondary outcomes were: Frenchay Activities Index; modified Rankin Score (mRS); survival; and stroke recurrence. ResultsMortality data were available for all 400 participants and functional data for 204/296 (69%) of survivors. The mean difference (95% CI) in PCS between Take Charge and control groups was 2.8 (-0.8 to 6.5) units, p = 0.12, and for independence (mRS 0-2) the odds ratio (95% CI) was 0.56 (0.28 to 1.16) p = 0.11, both favouring Take Charge with similar point estimates to those after 12 months. Point estimates for other outcomes also favoured Take Charge but were not statistically significant. ConclusionsDifferences in physical health and independence observed at 12 months, were sustained 5-6 years after stroke, but were not statistically significant.