Stroke Clinical Trial
Official title:
Optimising Psychoeducation for Transient Ischaemic Attack and Minor Stroke Management (OPTIMISM)
Transient Ischaemic Attack (TIA), also called 'ministroke' is characterised by shortlasting
symptoms that generally do not cause permanent damage. 'Minor stroke' is a term used to
describe a stroke with mild and nondisabling symptoms. TIA and minor stroke patients account
for more than half of all cases of stroke and they are at a higher risk to suffer a major
stroke. Currently, management of TIA/minor stroke patients is mainly focused on identifying
and reducing risk factors for a later stroke. However, people after a TIA often have limited
access for further specialist support from stroke-specific rehabilitation services. Although
there is variability in the level of recovery and severity of symptoms after TIA and minor
stroke, there is evidence that these patients may experience difficulties that affect their
quality of life including anxiety and depression.
This study aims to develop, tailor and target the delivery of a time-limited group
intervention that offers educational, psychological and social support for people following
TIA and minor stroke. A qualitative study (Phase 1) will be conducted with service users and
experts working with people with TIA/minor stroke to develop the psychoeducational
intervention. Following this, we will conduct a feasibility randomised controlled trial in
one centre (Phase 2) to explore whether this group psychoeducational intervention for people
after TIA and minor stroke carers is acceptable and to determine the feasibility of the
proposed evaluation and the sample size needed in a definite trial.
Participants will complete measures at baseline and then randomly allocated to receive the intervention or usual care. The intervention group will receive a group psychoeducational intervention (designed in Phase 1: Qualitative study) in addition to self-help leaflets and usual care. It is anticipated that the intervention will be offered in 6 two-hour sessions over 3 months by an assistant psychologist. The control group will receive usual care plus self-help leaflets on relevant topics. All participants will complete outcome measures at 3 and 6 months after randomisation. We will test the feasibility, tolerability and acceptability of delivering the intervention and will record data on study completion and attrition. Findings will inform the development of a larger trial and will determine if the content and delivery of the intervention meets the needs of people after TIA and minor stroke. ;
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