Psychoeducation for Transient Ischaemic Attack and Minor Stroke (OPTIMISM)
Primary Purpose
Transient Ischaemic Attack, Stroke
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Psychoeducation
Sponsored by
About this trial
This is an interventional treatment trial for Transient Ischaemic Attack
Eligibility Criteria
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.
Sites / Locations
- Nottingham University Hospitals NHS Trust
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Group psychoeducation
Control group
Arm Description
The intervention group will receive a group psychoeducational intervention (designed in Phase 1: Qualitative study) and usual care.
Participants in the usual care control group will continue to receive all other services routinely available to them as is usual practice.
Outcomes
Primary Outcome Measures
Number of participants recruited to the trial
Number of participants who completed the trial
Secondary Outcome Measures
Mood
General Health Questionnaire-30 (GHQ-30)
Health-related Quality of Life
EuroQuol-5D
Knowledge and Satisfaction
Knowledge and Satisfaction Questionnaire
Full Information
NCT ID
NCT02550392
First Posted
September 10, 2015
Last Updated
March 23, 2020
Sponsor
University of Nottingham
Collaborators
The Stroke Association, United Kingdom, Nottingham University Hospitals NHS Trust
1. Study Identification
Unique Protocol Identification Number
NCT02550392
Brief Title
Psychoeducation for Transient Ischaemic Attack and Minor Stroke
Acronym
OPTIMISM
Official Title
Optimising Psychoeducation for Transient Ischaemic Attack and Minor Stroke Management (OPTIMISM)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
March 2016 (undefined)
Primary Completion Date
December 2019 (Actual)
Study Completion Date
January 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Nottingham
Collaborators
The Stroke Association, United Kingdom, Nottingham University Hospitals NHS Trust
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Transient Ischaemic Attack, Stroke
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
64 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group psychoeducation
Arm Type
Experimental
Arm Description
The intervention group will receive a group psychoeducational intervention (designed in Phase 1: Qualitative study) and usual care.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Participants in the usual care control group will continue to receive all other services routinely available to them as is usual practice.
Intervention Type
Behavioral
Intervention Name(s)
Psychoeducation
Intervention Description
A time-limited group psychoeducational intervention that will aim to offer educational, psychological and social support.
Primary Outcome Measure Information:
Title
Number of participants recruited to the trial
Time Frame
up to 1 year
Title
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 Outcome Measure Information:
Title
Mood
Description
General Health Questionnaire-30 (GHQ-30)
Time Frame
baseline, 3 and 6 months follow-up
Title
Health-related Quality of Life
Description
EuroQuol-5D
Time Frame
baseline, 3 and 6 months follow-up
Title
Knowledge and Satisfaction
Description
Knowledge and Satisfaction Questionnaire
Time Frame
baseline, 3 and 6 months follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eirini Kontou, PhD DClinPsy
Organizational Affiliation
University of Nottingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nottingham University Hospitals NHS Trust
City
Nottingham
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Psychoeducation for Transient Ischaemic Attack and Minor Stroke
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