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

Cognitive Impairment Clinical Trial

Official title:

A Multicomponent Intervention to Rehabilitate Cognitive Impairment in People Post-stroke: Single-arm Feasibility Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05414539
• Other study ID #: OptiCogs
• Status: Completed
• Phase: N/A
• Start date: May 9, 2022
• Est. completion date: June 30, 2022

Study information

• Verified date: February 2022
• Source: University of Limerick
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

OptiCogs Online is a complex multicomponent intervention comprising of cognitive, physical activity and educational components.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: June 30, 2022
• Est. primary completion date: June 24, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Cognitive Impairment
• Myocardial Infarction
• Stroke
• Stroke, Cardiovascular

Intervention

Other:
• OptiCogs Online
A multicomponent intervention to rehabilitate cognitive deficits in people post-stroke

Locations

Country	Name	City	State
Ireland	University of Limerick	Limerick

Sponsors (1)

Lead Sponsor	Collaborator
University of Limerick

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment rate	The proportion of participants who are recruited to the study.	6 weeks
Primary	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
Primary	Adverse events	Number of participants with adverse events as a measure of safety. Adverse events include a fall, illness, medical complication etc.	6 weeks
Primary	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
Primary	Retention rate	The proportion of participants who are lost to follow-up	6 weeks
Secondary	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.	6 weeks
Secondary	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.	6 weeks
Secondary	Fatigue severity scale (FSS)	). 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	6 weeks
Secondary	PROMIS-10 Physical Functioning	• Physical function (PF) will be assessed using a physical functioning subset of the patient reported outcomes measurement information system (PROMIS) scale.	6 weeks
Secondary	Stroke Specific Quality of Life Scale	• Mood and social participation will be assessed using the relevant subscales of the Stroke-Specific Quality of Life Scale-12 (SSQoL-12).	6 weeks