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

• DOI: 10.1186/s13063-018-2669-5
• Publication Date: 2018-06-11T13:25:48Z
• Authors: Anne Forster; Suzanne Hartley; Lorna Barnard; Seline Ozer; Natasha Hardicre; Tom Crocker; Marie Fletcher; Lauren Moreau; Ross Atkinson; Claire Hulme; Ivana Holloway; Laetitia Schmitt; Allan House; Jenny Hewison; Gillian Richardson; Amanda Farrin
• Keywords: Stroke

Despite the evidence that many stroke survivors report longer term unmet needs, provision of care is limited. To address this, we are conducting a programme research to develop an evidence-based and replicable strategy. The developed complex intervention (named New Start), which includes needs identification, exploration social networks components problem solving self-management, was designed improve quality life by addressing increasing participation.A multicentre, cluster randomised controlled feasibility trial inform design possible future definitive (cRCT) explore potential clinical cost-effectiveness Start. Ten services across UK will be on 1:1 basis either implement Start or continue with usual only. delivered trained facilitators offered all within allocated arm. Stroke eligible for if they 4-6 months post-stroke residing in community. Carers (if available) also invited take part. Invitation participate initiated post outcome measures collected via postal questionnaires at 3, 6 9 after recruitment. Outcome data relating perceived health disability, wellbeing as well collected. A 'study trial' (SWAT) planned determine most acceptable format provide questionnaires. Details service usage economic evaluation. recruiting collecting outcomes assessed effectiveness investigated. An embedded process evaluation (reported separately) assess implementation fidelity clarify causal assumptions regarding implementation.This allow us gather important detailed methodological issues cRCT this intervention.ISRCTN38920246 . Registered 22 June 2016.