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

November 1, 2022 updated by: University of Limerick

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

9

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ireland
      • Limerick, Ireland
        • University of Limerick

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other: OptiCogs Online
A multicomponent intervention to rehabilitate cognitive deficits in people post-stroke

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recruitment rate
Time Frame: 6 weeks
The proportion of participants who are recruited to the study.
6 weeks
Adherence rate
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.
6 weeks
Adverse events
Time Frame: 6 weeks
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
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".
6 weeks
Retention rate
Time Frame: 6 weeks
The proportion of participants who are lost to follow-up
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oxford Cognitive Screen-plus (OCS-plus)
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.
6 weeks
Addenbrooke's Cognitive Assessment (III) ACE (III)
Time Frame: 6 weeks
Changes in cognitive function from pre-intervention to post-intervention in accordance with ACE III score out of 100.
6 weeks
Fatigue severity scale (FSS)
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
6 weeks
PROMIS-10 Physical Functioning
Time Frame: 6 weeks
• Physical function (PF) will be assessed using a physical functioning subset of the patient reported outcomes measurement information system (PROMIS) scale.
6 weeks
Stroke Specific Quality of Life Scale
Time Frame: 6 weeks
• Mood and social participation will be assessed using the relevant subscales of the Stroke-Specific Quality of Life Scale-12 (SSQoL-12).
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Limerick

Investigators

  • Principal Investigator: Sara Hayes, PhD, University of Limerick

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 9, 2022

Primary Completion (Actual)

June 24, 2022

Study Completion (Actual)

June 30, 2022

Study Registration Dates

First Submitted

February 21, 2022

First Submitted That Met QC Criteria

June 9, 2022

First Posted (Actual)

June 10, 2022

Study Record Updates

Last Update Posted (Actual)

November 2, 2022

Last Update Submitted That Met QC Criteria

November 1, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OptiCogs

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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