OptiCogs: A Multicomponent Intervention to Rehabilitate Cognitive Impairment in People Post-stroke

University of Limerick9 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Stroke, Cardiovascular Cognitive Impairment

Interventions

OptiCogs OnlineOTHER

A multicomponent intervention to rehabilitate cognitive deficits in people post-stroke

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Limerick

Limerick, Ireland

Outcomes

Primary Outcomes

Recruitment rate

The proportion of participants who are recruited to the study.

Time frame: 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.

Time frame: 6 weeks

Adverse events

Number of participants with adverse events as a measure of safety. Adverse events include a fall, illness, medical complication etc.

Time frame: 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".

Time frame: 6 weeks

Retention rate

The proportion of participants who are lost to follow-up

Time frame: 6 weeks

Secondary Outcomes

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.

Time frame: 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.

Data from ClinicalTrials.gov

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