Psychoeducation for Transient Ischaemic Attack and Minor Stroke

NCT02550392 | Completed

• 2 other identifiers: 15079TSA PDF 2015-01
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Transient Ischaemic Attack; Stroke

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Mood

  baseline, 3 and 6 months follow-up

• Health-related Quality of Life

  baseline, 3 and 6 months follow-up

• Knowledge and Satisfaction

  baseline, 3 and 6 months follow-up

Study Arms (2)

Group psychoeducation

EXPERIMENTAL

The intervention group will receive a group psychoeducational intervention (designed in Phase 1: Qualitative study) and usual care.

Behavioral: Psychoeducation

Control group

NO INTERVENTION

Participants in the usual care control group will continue to receive all other services routinely available to them as is usual practice.

Interventions

Psychoeducation BEHAVIORAL

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

Group psychoeducation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Nottingham: lead
• The Stroke Association, United Kingdom: collaborator
• Nottingham University Hospitals NHS Trust: collaborator

Study Sites (1)

Nottingham University Hospitals NHS Trust

Nottingham, United Kingdom

Location

MeSH Terms

Conditions

Ischemic Attack, Transient; Stroke

Condition Hierarchy (Ancestors)

Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Eirini Kontou, PhD DClinPsy

  University of Nottingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2015
• First Posted: September 15, 2015
• Study Start: March 1, 2016
• Primary Completion: December 1, 2019
• Study Completion: January 1, 2020
• Last Updated: March 25, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)