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Completed

NCT Number: NCT05414539

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

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

OptiCogs Online

Other

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

Primary outcomes

  1. Recruitment rate

    Time frame: 6 weeks

    The proportion of participants who are recruited to the study.

  2. 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.

  3. 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.

  4. 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".

  5. Retention rate

    Time frame: 6 weeks

    The proportion of participants who are lost to follow-up

Secondary outcomes

  1. 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.

  2. 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.

  3. 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

  4. 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.
  5. 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).

Sponsors and collaborators

Lead sponsor

University of Limerick

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jun 10, 2022
Registry last updated
Nov 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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