Optimising Psychoeducation for Transient Ischaemic Attack and Minor Stroke Management (OPTIMISM): Protocol for a feasibility randomised controlled trial

Abstract

Background: A transient ischaemic attack (TIA) and minor stroke are medical emergencies and often a warning sign of future strokes if remain untreated. Few studies have investigated the long-term psychosocial effects of TIA and minor stroke. Secondary prevention and medical management are often the primary focus with limited access offered for further psychosocial support. Psychoeducational interventions can provide education and advice to people with physical health conditions and, with suitable tailoring, could be appropriate for people after TIA and minor stroke. This study aims to develop a group psychoeducational intervention for people after TIA and minor stroke and to test whether it is acceptable and feasible. Methods: This mixed-methodology study involves two phases: Phase 1) A qualitative study to determine the content of a suitable intervention; Phase 2) A single-centre feasibility randomised controlled trial to evaluate the acceptability of this intervention. The overall study has ethical approval. Stroke survivors have been involved in designing and monitoring the trial. The aim is to recruit 30-40 participants from a Stroke/TIA Service, within 6 months following their diagnosis. Participants will be randomly allocated to either the usual care control group or the intervention group (psychoeducational programme). The programme will consist of six group sessions based on providing education, psychological and social support. The primary outcomes will relate to the feasibility aims of the study. Outcomes will be collected at 3 and 6 months to assess mood, quality of life, knowledge and satisfaction, and resource use. Discussion: There is a need to develop and evaluate effective interventions that enhance the education provided to people after TIA and minor stroke and to promote their psychosocial wellbeing. Findings will indicate the acceptability of the intervention and parameters needed to conduct a definitive trial. Registration: ClinicalTrials.gov ID NCT02550392; registered on 15 September 2015; status: completed.