Psychoeducation for Transient Ischaemic Attack and Minor Stroke (OPTIMISM)

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.

Study Overview

• Status: Completed
• Conditions: Stroke; Transient Ischaemic Attack
• Intervention / Treatment: Behavioral: Psychoeducation

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.

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Nottingham, United Kingdom
    • Nottingham University Hospitals NHS Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group psychoeducation; The intervention group will receive a group psychoeducational intervention (designed in Phase 1: Qualitative study) and usual care.	Behavioral: Psychoeducation; A time-limited group psychoeducational intervention that will aim to offer educational, psychological and social support.
No Intervention: Control group; Participants in the usual care control group will continue to receive all other services routinely available to them as is usual practice.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of participants recruited to the trial	up to 1 year
Number of participants who completed the trial	participants will be followed for the duration of the trial, an expected average of 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mood	General Health Questionnaire-30 (GHQ-30)	baseline, 3 and 6 months follow-up
Health-related Quality of Life	EuroQuol-5D	baseline, 3 and 6 months follow-up
Knowledge and Satisfaction	Knowledge and Satisfaction Questionnaire	baseline, 3 and 6 months follow-up

Collaborators and Investigators

• Sponsor: University of Nottingham
• Collaborators: Nottingham University Hospitals NHS Trust; The Stroke Association, United Kingdom
• Investigators: Principal Investigator: Eirini Kontou, PhD DClinPsy, University of Nottingham

Study record dates

Study Major Dates

• Study Start: March 1, 2016
• Primary Completion (Actual): December 1, 2019
• Study Completion (Actual): January 1, 2020

Study Registration Dates

• First Submitted: September 10, 2015
• First Submitted That Met QC Criteria: September 14, 2015
• First Posted (Estimate): September 15, 2015

Study Record Updates

• Last Update Posted (Actual): March 25, 2020
• Last Update Submitted That Met QC Criteria: March 23, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Ischemia; Stroke; Ischemia; Ischemic Attack, Transient
• Other Study ID Numbers: 15079; TSA PDF 2015-01 (Other Grant/Funding Number: Stroke Association)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO