Stroke Clinical Trial
— OPTIMISMOfficial title:
Optimising Psychoeducation for Transient Ischaemic Attack and Minor Stroke Management (OPTIMISM)
Verified date | March 2020 |
Source | University of Nottingham |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 64 |
Est. completion date | January 2020 |
Est. primary completion date | December 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Nottingham University Hospitals NHS Trust | Nottingham |
Lead Sponsor | Collaborator |
---|---|
University of Nottingham | Nottingham University Hospitals NHS Trust, The Stroke Association, United Kingdom |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of participants recruited to the trial | up to 1 year | ||
Primary | Number of participants who completed the trial | participants will be followed for the duration of the trial, an expected average of 12 months | ||
Secondary | Mood | General Health Questionnaire-30 (GHQ-30) | baseline, 3 and 6 months follow-up | |
Secondary | Health-related Quality of Life | EuroQuol-5D | baseline, 3 and 6 months follow-up | |
Secondary | Knowledge and Satisfaction | Knowledge and Satisfaction Questionnaire | baseline, 3 and 6 months follow-up |
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