University of Limerick
Limerick, Ireland
NCT Number: NCT05414539
OptiCogs Online is a complex multicomponent intervention comprising of cognitive, physical activity and educational components.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Limerick, Ireland
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
A multicomponent intervention to rehabilitate cognitive deficits in people post-stroke
Time frame: 6 weeks
The proportion of participants who are recruited to the study.
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.
Time frame: 6 weeks
Number of participants with adverse events as a measure of safety. Adverse events include a fall, illness, medical complication etc.
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".
Time frame: 6 weeks
The proportion of participants who are lost to follow-up
Time frame: 6 weeks
Changes in cognitive function from pre-intervention to post-intervention in accordance with the cut-offs for impairment for OCS-Plus subtasks.
Time frame: 6 weeks
Changes in cognitive function from pre-intervention to post-intervention in accordance with ACE III score out of 100.
Time frame: 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
Time frame: 6 weeks
Time frame: 6 weeks
University of Limerick
Other
A Multicomponent Intervention to Rehabilitate Cognitive Impairment in People Post-stroke: Single-arm Feasibility Study
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