Cognitive Impairment, Stroke, Cardiovascular
Conditions
Keywords
Feasibility, Stroke, Cognitive impairment, Multicomponent rehabilitation
Brief summary
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.
Interventions
OTHEROptiCogs Online
A multicomponent intervention to rehabilitate cognitive deficits in people post-stroke
Sponsors
University of Limerick
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
A non-randomised single-arm feasibility study using a pre-test: post-test design.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Retention rate | 6 weeks | The proportion of participants who are lost to follow-up |
| Recruitment rate | 6 weeks | The proportion of participants who are recruited to the study. |
| Adherence rate | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Oxford Cognitive Screen-plus (OCS-plus) | 6 weeks | Changes in cognitive function from pre-intervention to post-intervention in accordance with the cut-offs for impairment for OCS-Plus subtasks. |
| Addenbrooke's Cognitive Assessment (III) ACE (III) | 6 weeks | Changes in cognitive function from pre-intervention to post-intervention in accordance with ACE III score out of 100. |
| Fatigue severity scale (FSS) | 6 weeks | ). 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 |
| PROMIS-10 Physical Functioning | 6 weeks | • Physical function (PF) will be assessed using a physical functioning subset of the patient reported outcomes measurement information system (PROMIS) scale. |
| Stroke Specific Quality of Life Scale | 6 weeks | • Mood and social participation will be assessed using the relevant subscales of the Stroke-Specific Quality of Life Scale-12 (SSQoL-12). |
Countries
Ireland
Outcome results
None listed