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Completed

NCT Number: NCT02550392

Psychoeducation for Transient Ischaemic Attack and Minor Stroke

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.

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Key information

Conditions

Transient Ischaemic Attack Brain Diseases Brain Ischemia Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Ischemic Attack, Transient Nervous System Diseases Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nottingham University Hospitals NHS Trust

Nottingham, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Psychoeducation

Behavioral

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

Primary outcomes

  1. Number of participants recruited to the trial

    Time frame: up to 1 year

  2. Number of participants who completed the trial

    Time frame: participants will be followed for the duration of the trial, an expected average of 12 months

Secondary outcomes

  1. Mood

    Time frame: baseline, 3 and 6 months follow-up

    General Health Questionnaire-30 (GHQ-30)

  2. Health-related Quality of Life

    Time frame: baseline, 3 and 6 months follow-up

    EuroQuol-5D

  3. Knowledge and Satisfaction

    Time frame: baseline, 3 and 6 months follow-up

    Knowledge and Satisfaction Questionnaire

Sponsors and collaborators

Lead sponsor

University of Nottingham

Other

Collaborators

  • Nottingham University Hospitals NHS Trust
  • The Stroke Association, United Kingdom

Registry information

Official study title

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

Acronym: OPTIMISM

Important dates

Study start
2016
Primary completion
2019
Study completion
2020
First posted
Sep 15, 2015
Registry last updated
Mar 25, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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