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

NCT ID: NCT05414539

Last Updated: 2022-11-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-09
• Study Completion Date: 2022-06-30

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.

Conditions

Stroke, Cardiovascular; Cognitive Impairment

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Intervention group

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.

Group Type: EXPERIMENTAL

OptiCogs Online

Intervention Type: OTHER

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

Interventions

OptiCogs Online

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Limerick

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sara Hayes, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Limerick

Locations

University of Limerick

Limerick, , Ireland

Countries

Ireland

References

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.

Reference Type: DERIVED

PMID: 37853485 (View on PubMed)

Other Identifiers

OptiCogs

Identifier Type: -

Identifier Source: org_study_id