Clinical trial NCT02550392: Psychoeducation for Transient Ischaemic Attack and Minor Stroke
Official title: Optimising Psychoeducation for Transient Ischaemic Attack and Minor Stroke Management (OPTIMISM)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Transient Ischaemic Attack
Stroke
Lead sponsor: University of Nottingham
Sponsor class: OTHER
Collaborators: name: The Stroke Association, United Kingdom
name: Nottingham University Hospitals NHS Trust
First posted: 2015-09-15
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion criteria:

* adults with a first/recurrent TIA or minor stroke;
* identified within 6 months of their diagnosis;
* who are independent with activities of daily living;
* who consent to take part

Exclusion criteria:

* diagnosis of dementia;
* receiving psychological interventions for mental health difficulties immediately prior to their TIA/minor stroke, visual or hearing impairments that would impact on ability to complete baseline assessments;
* cognitive or communication difficulties that would impact on ability to complete baseline assessments and to participate in group sessions;
* unable to communicate in English.

Primary outcomes:
measure: Number of participants recruited to the trial
timeFrame: up to 1 year
measure: Number of participants who completed the trial
timeFrame: participants will be followed for the duration of the trial, an expected average of 12 months
Secondary outcomes:
measure: Mood
timeFrame: baseline, 3 and 6 months follow-up
measure: Health-related Quality of Life
timeFrame: baseline, 3 and 6 months follow-up
measure: Knowledge and Satisfaction
timeFrame: baseline, 3 and 6 months follow-up
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospitals NHS Trust
Study officials:
affiliation: University of Nottingham
name: Eirini Kontou, PhD DClinPsy
role: PRINCIPAL_INVESTIGATOR
References: