Transient Ischaemic AttackOPTIMISMNCT02550392
Psychoeducation for Transient Ischaemic Attack and Minor Stroke
A study testing Psychoeducation in people with Transient Ischaemic Attack and Stroke, run by University of Nottingham at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Transient Ischaemic Attack, Stroke
- What is being tested?
- Psychoeducation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2016to Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Nottingham University Hospitals NHS Trust
Nottingham
About this study
Official title: Optimising Psychoeducation for Transient Ischaemic Attack and Minor Stroke Management (OPTIMISM)
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.
Read the 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.
- Conditions
- Transient Ischaemic Attack, Stroke
- Being tested
- Psychoeducation
- Medical subject headings
- Ischemic Attack, Transient, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PsychoeducationBehavioural
A time-limited group psychoeducational intervention that will aim to offer educational, psychological and social support.
| Study group | Role | What they receive |
|---|---|---|
| Group psychoeducation | Experimental | The intervention group will receive a group psychoeducational intervention (designed in Phase 1: Qualitative study) and usual care. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants recruited to the trial
Measured: up to 1 year
Number of participants who completed the trial
Measured: participants will be followed for the duration of the trial, an expected average of 12 months
Secondary outcomes (3)
Mood
General Health Questionnaire-30 (GHQ-30)
Measured: baseline, 3 and 6 months follow-up
Health-related Quality of Life
EuroQuol-5D
Measured: baseline, 3 and 6 months follow-up
Knowledge and Satisfaction
Knowledge and Satisfaction Questionnaire
Measured: baseline, 3 and 6 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2015 (estimated)
- Study startMar 2016
- Primary completionDec 2019
- Study completionJan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transient Ischaemic AttackStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Collaborators
- The Stroke Association, United Kingdom, Nottingham University Hospitals NHS Trust
- Responsible party
- Sponsor
- Investigators
- Eirini Kontou, PhD DClinPsy, Principal investigator, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02550392
- Sponsor's protocol ID
- 15079
- Other IDs
- TSA PDF 2015-01
- Acronym
- OPTIMISM
- Status last verified
- Mar 2020
- First submitted
- 10 Sep 2015
- Last updated
- 25 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimising Psychoeducation for Transient Ischaemic Attack and Minor Stroke Management (OPTIMISM)
- ClinicalTrials.gov ID
- NCT02550392
- Acronym / sponsor ID
- OPTIMISM / 15079
- Conditions
- Transient Ischaemic Attack, Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Collaborators
- The Stroke Association, United Kingdom, Nottingham University Hospitals NHS Trust
- Study start
- Mar 2016
- Primary completion
- Dec 2019 (actual)
- Study completion
- Jan 2020 (actual)
- First posted
- 15 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group psychoeducation | Experimental | Behavioral: PsychoeducationThe intervention group will receive a group psychoeducational intervention (designed in Phase 1: Qualitative study) and usual care. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PsychoeducationA time-limited group psychoeducational intervention that will aim to offer educational, psychological and social support. | Behavioural | Group psychoeducation |
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
3 secondary outcomes
Mood
Time frame: baseline, 3 and 6 months follow-up
Health-related Quality of Life
Time frame: baseline, 3 and 6 months follow-up
Knowledge and Satisfaction
Time frame: baseline, 3 and 6 months follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eirini Kontou, PhD DClinPsy principal investigator
University of Nottingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychoeducation in people with Transient Ischaemic Attack and Stroke, run by University of Nottingham at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants recruited to the trial (time frame: up to 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2020.