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OptiCogs Online is a complex multicomponent intervention comprising of cognitive, physical activity and educational components.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OptiCogs Online | Other | A multicomponent intervention to rehabilitate cognitive deficits in people post-stroke |
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| Measure | Description | Time Frame |
|---|---|---|
| Recruitment rate | The proportion of participants who are recruited to the study. | 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. | 6 weeks |
| Adverse events | Number of participants with adverse events as a measure of safety. Adverse events include a fall, illness, medical complication etc. | 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". | 6 weeks |
| Retention rate | The proportion of participants who are lost to follow-up | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 weeks |
| Addenbrooke's Cognitive Assessment (III) ACE (III) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sara Hayes, PhD | University of Limerick | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Limerick | Limerick | Ireland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37853485 | Derived | 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. |
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| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D060825 | Cognitive Dysfunction |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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A non-randomised single-arm feasibility study using a pre-test: post-test design.
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Changes in cognitive function from pre-intervention to post-intervention in accordance with ACE III score out of 100.
| 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 | 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. | 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). | 6 weeks |
| D007238 |
| Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |