Psychoeducation for Transient Ischaemic Attack and Minor Stroke

Stroke Clinical Trial

— OPTIMISM  

Official title:

Optimising Psychoeducation for Transient Ischaemic Attack and Minor Stroke Management (OPTIMISM)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02550392
• Other study ID #: 15079
• Secondary ID: TSA PDF 2015-01
• Status: Completed
• Phase: N/A
• Start date: March 2016
• Est. completion date: January 2020

Study information

• Verified date: March 2020
• Source: University of Nottingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: January 2020
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Ischemia
• Ischemic Attack, Transient
• Stroke
• Transient Ischaemic Attack

Intervention

Behavioral:
• Psychoeducation
A time-limited group psychoeducational intervention that will aim to offer educational, psychological and social support.

Locations

Country	Name	City	State
United Kingdom	Nottingham University Hospitals NHS Trust	Nottingham

Sponsors (3)

Lead Sponsor	Collaborator
University of Nottingham	Nottingham University Hospitals NHS Trust, The Stroke Association, United Kingdom

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants recruited to the trial		up to 1 year
Primary	Number of participants who completed the trial		participants will be followed for the duration of the trial, an expected average of 12 months
Secondary	Mood	General Health Questionnaire-30 (GHQ-30)	baseline, 3 and 6 months follow-up
Secondary	Health-related Quality of Life	EuroQuol-5D	baseline, 3 and 6 months follow-up
Secondary	Knowledge and Satisfaction	Knowledge and Satisfaction Questionnaire	baseline, 3 and 6 months follow-up