An intervention to support stroke survivors and their carers in the longer term: results of a cluster randomised controlled feasibility trial (LoTS2Care)

Abstract

Background To address the limited provision of longer-term stroke care, we conducted a programme of research (LoTS2Care) to develop and test an intervention to form part of a replicable longer-term care strategy. New Start, a programme of facilitated self-management, was developed to be delivered at 6 months post-stroke by trained facilitators. Here, we report the findings from the final workstream of this programme, which aimed to evaluate the feasibility and acceptability of implementing a future definitive cluster randomised controlled trial of the developed intervention (New Start) to support stroke survivors and their carers in the longer term. Methods A feasibility cluster randomised controlled trial was conducted in English and Welsh NHS stroke services. Stroke services (clusters) were randomised on a 1:1 basis to implement New Start or continue with usual care only. Community-dwelling stroke survivors between 4 and 6 months post-stroke were invited to participate in the trial by post. Outcome measures were collected via post at 3, 6 and 9 months after recruitment. Recruitment and follow-up rates, delivery and uptake of the intervention, data collection feasibility (including postal outcome measures of health and disability, mental well-being at 3, 6, and 9 months post-recruitment) and safety were assessed. Results Ten stroke services were recruited. A total of 1127 stroke survivors were screened for participation, and 269 were registered (New Start, n = 145; usual care, n = 124). Retention was high with 239 (89%) stroke survivors being available for follow-up at 9 months, and high return rates of postal questionnaires were achieved (80.3% at 9 months). Intervention training was successfully delivered, and New Start was offered to 95.2% of trial participants in the intervention arm. Uptake was variable, however, ranging from 11.8 to 75.0%. There were no safety concerns. Conclusions Stroke service recruitment and longer-term stroke survivor postal recruitment and outcome data collection are feasible; however, refinement of intervention targeting and delivery is required prior to undertaking a definitive trial. Trial registration ISRCTN38920246. Registered 22 June 2016 (http://www.isrctn.com/ISRCTN38920246).