Clinical Trial: Psychoeducation for Transient Ischaemic Attack and Minor Stroke

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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 Summary: 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.
Sponsor: University of Nottingham

Current Primary Outcome:

  • Number of participants recruited to the trial [ Time Frame: up to 1 year ]
  • 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 ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Mood [ Time Frame: baseline, 3 and 6 months follow-up ]
    Hospital Anxiety and Depression Scale (HADS)
  • Quality of life [ Time Frame: baseline, 3 and 6 months follow-up ]
    EuroQuol-5D
  • Activities of daily living [ Time Frame: baseline, 3 and 6 months follow-up ]
    Nottingham Activities of Daily Living (NEADL)


Original Secondary Outcome: Same as current

Information By: University of Nottingham

Dates:
Date Received: September 10, 2015
Date Started: March 2016
Date Completion: October 2018
Last Updated: November 30, 2016
Last Verified: October 2016