OptiCogs: A Multicomponent Intervention to Rehabilitate Cognitive Impairment in People Post-stroke
A Multicomponent Intervention to Rehabilitate Cognitive Impairment in People Post-stroke: Single-arm Feasibility Study
1 other identifier
interventional
9
1 country
1
Brief Summary
OptiCogs Online is a complex multicomponent intervention comprising of cognitive, physical activity and educational components.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2022
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 21, 2022
CompletedStudy Start
First participant enrolled
May 9, 2022
CompletedFirst Posted
Study publicly available on registry
June 10, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 24, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2022
CompletedNovember 2, 2022
February 1, 2022
2 months
February 21, 2022
November 1, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
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
Secondary Outcomes (5)
Oxford Cognitive Screen-plus (OCS-plus)
6 weeks
Addenbrooke's Cognitive Assessment (III) ACE (III)
6 weeks
Fatigue severity scale (FSS)
6 weeks
PROMIS-10 Physical Functioning
6 weeks
Stroke Specific Quality of Life Scale
6 weeks
Study Arms (1)
Intervention group
EXPERIMENTALOptiCogs 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.
Interventions
A multicomponent intervention to rehabilitate cognitive deficits in people post-stroke
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Limerick
Limerick, Ireland
Related Publications (1)
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.
PMID: 37853485DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sara Hayes, PhD
University of Limerick
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 21, 2022
First Posted
June 10, 2022
Study Start
May 9, 2022
Primary Completion
June 24, 2022
Study Completion
June 30, 2022
Last Updated
November 2, 2022
Record last verified: 2022-02