Stroke, CardiovascularNCT05414539
OptiCogs: A Multicomponent Intervention to Rehabilitate Cognitive Impairment in People Post-stroke
A study testing OptiCogs Online in people with Stroke, Cardiovascular and Cognitive Impairment, run by University of Limerick at 1 site in Ireland.
Trial summary
OptiCogs Online is a complex multicomponent intervention comprising of cognitive, physical activity and educational components. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Cardiovascular, Cognitive Impairment
- What is being tested?
- OptiCogs Online
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteIreland
- Study dates
- 9 May 2022to 30 Jun 2022
- 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
- People with a physician-confirmed diagnosis of stroke. Stroke may be ischaemic or haemorrhagic in nature.
- People aged ≥18 years old; with confirmed mild to moderate cognitive impairment using the Oxford Cognitive Screen (OCS) (in accordance with cut-offs for impairment for OCS-plus subtasks (Demeyere et al. 2021a) and the Addenbroke's Examination III (ACE III) with a cut-off score of 88/100 (Takenoshita et al. 2019).
- People post-stroke who have a Modified Rankin Scale (MRS) score of 0-3
- Capacity to provide informed consent
- People post-stroke who are able to express their basic needs, verbally or not
- Have access to a smartphone, laptop or tablet with an internet connection
- Willingness/ interest in participating in an online intervention
- Physician-confirmed suitability to partake in this intervention
Who cannot join
- Physician-confirmed contraindications for undertaking physical activity e.g., safety, presence of unstable heart disease
- People with diagnosed TIA will be excluded
- People post-stroke with known active delirium or dementia will be excluded
- People post-stroke with a diagnosis of known pre-stroke cognitive impairment
- People post-stroke with moderate or severe visuospatial neglect
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicomponent Intervention to Rehabilitate Cognitive Impairment in People Post-stroke: Single-arm Feasibility Study
OptiCogs Online is a complex multicomponent intervention comprising of cognitive, physical activity and educational components.
Read the detailed description
OptiCogs Online was developed in accordance with the MRC framework for the development and evaluation of complex interventions. Given the known interactions and interconnectivity of cognitive domains required for optimal cognitive functioning post-stroke, a systematic review of 64 studies addressing all types of non-pharmacological rehabilitation interventions which may improve multiple cognitive domains in people post-stroke was conducted. Within this review, rehabilitation interventions were categorised as multicomponent interventions, physical activity interventions, cognitive rehabilitation interventions, NIBS protocols, occupational-based interventions and other interventions. The most consistent evidence in our systematic review and meta-analysis supported multicomponent interventions, with significant improvement demonstrated for general cognitive function and memory outcomes. Specifically, multicomponent interventions wherein a form of cognitive rehabilitation was conducted in conjunction with a form of physical activity were shown to improve cognitive functioning in people post-stroke.
As well as meta-analytic evidence, we drew from qualitative findings which explored the perspectives of PpS, caregivers and healthcare professionals on the design and delivery of an intervention to improve cognitive functioning in PpS. Qualitative findings and input from clinical experts emphasised the importance of information provision, peer support and meaningful engagement. As such, each component of OptiCogs Online is supplemented with an educational or 'cognitive education' session wherein group discussion covers different aspects of cognitive functioning. As well as drawing on findings from our qualitative study, this 'cognitive education' component is underpinned by the Bridges stroke self-management package and based on self-efficacy principles.
To this end, a complex multicomponent intervention comprising of cognitive, physical activity and educational components was developed in line with the MRC framework.
- Conditions
- Stroke, Cardiovascular, Cognitive Impairment
- Being tested
- OptiCogs Online
- Keywords
- Feasibility, Stroke, Cognitive impairment, Multicomponent rehabilitation
- Medical subject headings
- Myocardial Infarction, Cognitive Dysfunction, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OptiCogs OnlineOther
A multicomponent intervention to rehabilitate cognitive deficits in people post-stroke
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | OptiCogs Online is a 6-week telehealth intervention consisting of cognitive, physical activity and educational components. Cognitive component of the intervention: Throughout the six-week intervention period, there will be three individualised one-to-one cognitive sessions (occurring on week one, week three and week five), delivered by an occupational therapist. Physical activity: The physical activity component will be delivered via telehealth by a physiotherapist.
* Aerobic: Progressions from Week 1-Week 6 will result in individual achieving 60 mins moderate intensity aerobic activity @ frequency of 3 times per week as tolerated.
* Muscular strengthening: Progressions from Week 1-Week 6 will result in the person post-stroke achieving 10 strengthening exercises x 10 reps x 3 sets @ frequency of 3 times per week as tolerated. Cognitive education: The cognitive education component is underpinned by the Bridges stroke self-management package and based on self-efficacy principles. Receives: Other: OptiCogs Online |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate
The proportion of participants who are recruited to the study.
Measured: 6 weeks
Adherence rate
The proportion of participants who adhere to the treatment protocol of 6 weeks. We will determine the level of adherence to the intervention protocol using the self-report diary.
Measured: 6 weeks
Adverse events
Number of participants with adverse events as a measure of safety. Adverse events include a fall, illness, medical complication etc.
Measured: 6 weeks
Acceptability of OptiCogs Online
The proportion of participants reporting that OptiCogs Online is acceptable. Acceptability (satisfaction) of the OptiCogs intervention will be assessed using a self-report questionnaire developed by the researchers containing 5-point Likert scales: 1= "strongly disagree"; 2= "disagree"; 3= "neutral"; 4= "agree"; 5= "strongly agree".
Measured: 6 weeks
Retention rate
The proportion of participants who are lost to follow-up
Measured: 6 weeks
Secondary outcomes (5)
Oxford Cognitive Screen-plus (OCS-plus)
Changes in cognitive function from pre-intervention to post-intervention in accordance with the cut-offs for impairment for OCS-Plus subtasks.
Measured: 6 weeks
Addenbrooke's Cognitive Assessment (III) ACE (III)
Changes in cognitive function from pre-intervention to post-intervention in accordance with ACE III score out of 100.
Measured: 6 weeks
Fatigue severity scale (FSS)
). The FSS is a 9-item scale which measures the severity of fatigue and its effect on ADLs on a 7-point scale. The FSS is shown as a valid and reliable measure of fatigue in people post-stroke
Measured: 6 weeks
PROMIS-10 Physical Functioning
- Physical function (PF) will be assessed using a physical functioning subset of the patient reported outcomes measurement information system (PROMIS) scale.
Measured: 6 weeks
Stroke Specific Quality of Life Scale
- Mood and social participation will be assessed using the relevant subscales of the Stroke-Specific Quality of Life Scale-12 (SSQoL-12).
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2022
- Study start9 May 2022
- Primary completion24 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stroke, CardiovascularStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A non-randomised single-arm feasibility study using a pre-test: post-test design.
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Limerick
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sara Hayes, PhD, Principal investigator, University of Limerick
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05414539
- Sponsor's protocol ID
- OptiCogs
- Status last verified
- Feb 2022
- First submitted
- 21 Feb 2022
- Last updated
- 2 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
O' Donoghue M, Boland P, Taylor S, Hennessy E, Murphy E, Leahy S, McManus J, Lisiecka D, Purtill H, Galvin R, Hayes S. OptiCogs: feasibility of a multicomponent intervention to rehabilitate people with cognitive impairment post-stroke. Pilot Feasibility Stud. 2023 Oct 18;9(1):178. doi: 10.1186/s40814-023-01300-7.
PubMed 37853485
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicomponent Intervention to Rehabilitate Cognitive Impairment in People Post-stroke: Single-arm Feasibility Study
- ClinicalTrials.gov ID
- NCT05414539
- Acronym / sponsor ID
- OptiCogs
- Conditions
- Stroke, Cardiovascular, Cognitive Impairment
- Keywords
- Feasibility, Stroke, Cognitive impairment, Multicomponent rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University of LimerickUniversity, hospital or other
- Study start
- 9 May 2022 (actual)
- Primary completion
- 24 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 10 Jun 2022 (actual)
- 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.
OptiCogs Online is a complex multicomponent intervention comprising of cognitive, physical activity and educational components.
Detailed description
OptiCogs Online was developed in accordance with the MRC framework for the development and evaluation of complex interventions. Given the known interactions and interconnectivity of cognitive domains required for optimal cognitive functioning post-stroke, a systematic review of 64 studies addressing all types of non-pharmacological rehabilitation interventions which may improve multiple cognitive domains in people post-stroke was conducted. Within this review, rehabilitation interventions were categorised as multicomponent interventions, physical activity interventions, cognitive rehabilitation interventions, NIBS protocols, occupational-based interventions and other interventions. The most consistent evidence in our systematic review and meta-analysis supported multicomponent interventions, with significant improvement demonstrated for general cognitive function and memory outcomes. Specifically, multicomponent interventions wherein a form of cognitive rehabilitation was conducted in conjunction with a form of physical activity were shown to improve cognitive functioning in people post-stroke.
As well as meta-analytic evidence, we drew from qualitative findings which explored the perspectives of PpS, caregivers and healthcare professionals on the design and delivery of an intervention to improve cognitive functioning in PpS. Qualitative findings and input from clinical experts emphasised the importance of information provision, peer support and meaningful engagement. As such, each component of OptiCogs Online is supplemented with an educational or 'cognitive education' session wherein group discussion covers different aspects of cognitive functioning. As well as drawing on findings from our qualitative study, this 'cognitive education' component is underpinned by the Bridges stroke self-management package and based on self-efficacy principles.
To this end, a complex multicomponent intervention comprising of cognitive, physical activity and educational components was developed in line with the MRC framework.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A non-randomised single-arm feasibility study using a pre-test: post-test design.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: OptiCogs OnlineOptiCogs Online is a 6-week telehealth intervention consisting of cognitive, physical activity and educational components. Cognitive component of the intervention: Throughout the six-week intervention period, there will be three individualised one-to-one cognitive sessions (occurring on week one, week three and week five), delivered by an occupational therapist. Physical activity: The physical activity component will be delivered via telehealth by a physiotherapist. * Aerobic: Progressions from Week 1-Week 6 will result in individual achieving 60 mins moderate intensity aerobic activity @ frequency of 3 times per week as tolerated. * Muscular strengthening: Progressions from Week 1-Week 6 will result in the person post-stroke achieving 10 strengthening exercises x 10 reps x 3 sets @ frequency of 3 times per week as tolerated. Cognitive education: The cognitive education component is underpinned by the Bridges stroke self-management package and based on self-efficacy principles. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- People with a physician-confirmed diagnosis of stroke. Stroke may be ischaemic or haemorrhagic in nature.
- People aged ≥18 years old; with confirmed mild to moderate cognitive impairment using the Oxford Cognitive Screen (OCS) (in accordance with cut-offs for impairment for OCS-plus subtasks (Demeyere et al. 2021a) and the Addenbroke's Examination III (ACE III) with a cut-off score of 88/100 (Takenoshita et al. 2019).
- People post-stroke who have a Modified Rankin Scale (MRS) score of 0-3
- Capacity to provide informed consent
- People post-stroke who are able to express their basic needs, verbally or not
Key exclusion criteria (5 listed)
- Physician-confirmed contraindications for undertaking physical activity e.g., safety, presence of unstable heart disease
- People with diagnosed TIA will be excluded
- People post-stroke with known active delirium or dementia will be excluded
- People post-stroke with a diagnosis of known pre-stroke cognitive impairment
- People post-stroke with moderate or severe visuospatial neglect
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 |
|---|---|---|
| OptiCogs OnlineA multicomponent intervention to rehabilitate cognitive deficits in people post-stroke | Other | Intervention group |
Primary outcome
Recruitment rate
Time frame: 6 weeks
The proportion of participants who are recruited to the study.
Adherence rate
Time frame: 6 weeks
The proportion of participants who adhere to the treatment protocol of 6 weeks. We will determine the level of adherence to the intervention protocol using the self-report diary.
Adverse events
Time frame: 6 weeks
Number of participants with adverse events as a measure of safety. Adverse events include a fall, illness, medical complication etc.
Acceptability of OptiCogs Online
Time frame: 6 weeks
The proportion of participants reporting that OptiCogs Online is acceptable. Acceptability (satisfaction) of the OptiCogs intervention will be assessed using a self-report questionnaire developed by the researchers containing 5-point Likert scales: 1= "strongly disagree"; 2= "disagree"; 3= "neutral"; 4= "agree"; 5= "strongly agree".
Retention rate
Time frame: 6 weeks
The proportion of participants who are lost to follow-up
5 secondary outcomes
Oxford Cognitive Screen-plus (OCS-plus)
Time frame: 6 weeks
Addenbrooke's Cognitive Assessment (III) ACE (III)
Time frame: 6 weeks
Fatigue severity scale (FSS)
Time frame: 6 weeks
PROMIS-10 Physical Functioning
Time frame: 6 weeks
Stroke Specific Quality of Life Scale
Time frame: 6 weeks
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 2 Nov 2022.
- Derived from this study: PubMed 37853485O' Donoghue M, Boland P, Taylor S, Hennessy E, Murphy E, Leahy S, McManus J, Lisiecka D, Purtill H, Galvin R, Hayes S. OptiCogs: feasibility of a multicomponent intervention to rehabilitate people with cognitive impairment post-stroke. Pilot Feasibility Stud. 2023 Oct 18;9(1):178. doi: 10.1186/s40814-023-01300-7.
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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.
Sara Hayes, PhD principal investigator
University of Limerick
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OptiCogs Online in people with Stroke, Cardiovascular and Cognitive Impairment, run by University of Limerick at 1 site in Ireland.
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 8 inclusion and 5 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 2 Nov 2022. 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 Ireland. 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?
Recruitment rate (time frame: 6 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05414539, which also lists 1 linked publication.
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 2 Nov 2022.