- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06021470
The StrokeCog Study: Cognitive Rehabilitation Intervention in Stroke (StrokeCog-R)
The StrokeCog Study: a Randomised Pilot Study of a Novel Cognitive Rehabilitation Intervention in Stroke
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Stroke is a leading cause of death and disability in Ireland and worldwide. Many people are aware of the physical disabilities that occur following stroke, but are less aware of the cognitive problems that people experience. Cognitive problems, or cognitive impairment, include difficulties with thinking, memory and concentration. They affect up to 60% of people after stroke. Stroke survivors and their families describe cognitive impairment as one of the most difficult stroke outcomes to deal with, and the biggest obstacle to returning to pre-stroke life.
Rehabilitation of post-stroke cognitive impairment has received little attention compared with physical rehabilitation. Current evidence indicates that cognitive impairment continues to decline and - especially if the person has another stroke - develops into dementia, one of the main reasons people move to long-term, or nursing home, care (LTC). Intervening to rehabilitate cognitive impairment may halt further decline and/or improve cognitive function, thus improving quality of life, and preventing progression to dementia and LTC.
The StrokeCog research team has developed a cognitive intervention based on extensive review of international studies and in-depth consultation with people who have had a stroke, their family members, and healthcare professionals working with people following stroke. The researchers have already tested this intervention with a very small number of patients with stroke-related cognitive impairment. Working with patient representatives, this research programme seeks to further test this intervention with a larger sample of patients with stroke-related cognitive problems. The researchers will collect information on the best way to recruit patients into the study, how many complete the intervention, and examine initial results on the benefits of the intervention. The team will collect and analyse detailed information on the costs associated with delivering this intervention. The study will provide strong evidence on whether the intervention is worthy of further investigation in a larger-scale research trial.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Anne Hickey, PhD
- Email: ahickey@rcsi.com
Study Contact Backup
- Name: Niamh Corbett, MA
- Phone Number: 0872051887
- Email: niamhcorbett@rcsi.ie
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- WHO-defined stroke, to include ICD-10 codes 160 (subarachnoid haemorrhage), 161 (intracerebral haemorrhage), 163 (cerebral infarction) including sub-categories, and 164 (stroke not specified as haemorrhage or infarction);
- First-ever and recurrent stroke;
- Age 18 and over (no upper age limit);
- Community dwelling (i.e., normal place of residence is not in a long-term care facility)
- Is a resident in the Republic of Ireland
- Capable of providing informed consent
Exclusion Criteria:
- Transient ischaemic attack;
- Aphasia;
- Poor English language ability;
- Nursing home resident;
- Dementia or severe cognitive impairment;
- Neurodegenerative disorder;
- Current psychiatric disorder (as defined by DSM-V or ICD-II criteria);
- Terminal illness.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cognitive rehabilitation intervention arm
Five-week group-based and largely interactive format, with groups of four patients.
Short presentations are delivered by the clinical neuropsychologist relating to psychoeducation and adjustment to stroke-related deficits in executive function, attention, and memory, respectively, and strategies addressing the activities and participation levels of functioning.
Each session lasts approximately 2.5 hours, with a break in the middle.
Tailored home activities are included for completion between group sessions to encourage self-efficacy and generalisation of skills and strategies.
A member of the research team contacts all participants by telephone twice a week to assess engagement and reported self-efficacy in managing cognitive difficulties.
In addition, a weekly text message is sent to all participants.
In the proposed pilot RCT, for those receiving the intervention, the text message will contain tips on implementing compensatory strategies.
|
The intervention comprises a five-week group-based cognitive rehabilitation intervention delivered by a clinical neuropsychologist, with home activities tailored to each stroke survivor's identified goals.
Sessions involve four patients and are delivered once per week lasting 2.5 hours with breaks.
|
No Intervention: Usual care
Those in the control group will be allocated to usual care from their multidisciplinary rehabilitation team in both acute and rehabilitation settings. Usual rehabilitation care is likely to vary across hospital settings (acute vs. rehabilitation). Information about type, dose, and amount of rehabilitation therapy will be captured from patients' medical charts in both the intervention and control arm of the study. A member of the research team (RA) contacts all participants by telephone twice a week to assess engagement and reported self-efficacy in managing cognitive difficulties. In addition, a weekly text message is sent to all participants. For those in the wait-list control condition, the text message will contain a positive affirmation. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Digit Span forward & backward (National Institute of Neurological Disorders & Stroke (NINDS) Assessment Battery)
Time Frame: Patients will complete these cognitive assessments at three time points: prior to (1) and following (2) the 5-week group based rehabilitation period (or control period), and at four months post-intervention (3).
|
The primary outcome is cognitive function, assessed using the standardised National Institute of Neurological Disorders & Stroke (NINDS) Assessment battery.
The primary outcome will be used for purposes of estimating the effect size (including standard deviation) to inform a power calculation for estimation of sample size for a definitive trial.
|
Patients will complete these cognitive assessments at three time points: prior to (1) and following (2) the 5-week group based rehabilitation period (or control period), and at four months post-intervention (3).
|
Verbal Fluency (National Institute of Neurological Disorders & Stroke (NINDS) Assessment Battery)
Time Frame: Patients will complete these cognitive assessments at three time points: prior to (1) and following (2) the 5-week group based rehabilitation period (or control period), and at four months post-intervention (3).
|
The primary outcome is cognitive function, assessed using the standardised National Institute of Neurological Disorders & Stroke (NINDS) Assessment battery.
The primary outcome will be used for purposes of estimating the effect size (including standard deviation) to inform a power calculation for estimation of sample size for a definitive trial.
|
Patients will complete these cognitive assessments at three time points: prior to (1) and following (2) the 5-week group based rehabilitation period (or control period), and at four months post-intervention (3).
|
Colour Trails Tests A&B (National Institute of Neurological Disorders & Stroke (NINDS) Assessment Battery)
Time Frame: Patients will complete these cognitive assessments at three time points: prior to (1) and following (2) the 5-week group based rehabilitation period (or control period), and at four months post-intervention (3).
|
The primary outcome is cognitive function, assessed using the standardised National Institute of Neurological Disorders & Stroke (NINDS) Assessment battery.
The primary outcome will be used for purposes of estimating the effect size (including standard deviation) to inform a power calculation for estimation of sample size for a definitive trial.
|
Patients will complete these cognitive assessments at three time points: prior to (1) and following (2) the 5-week group based rehabilitation period (or control period), and at four months post-intervention (3).
|
15-Item modified Boston Naming Test (National Institute of Neurological Disorders & Stroke (NINDS) Assessment Battery)
Time Frame: Patients will complete these cognitive assessments at three time points: prior to (1) and following (2) the 5-week group based rehabilitation period (or control period), and at four months post-intervention (3).
|
The primary outcome is cognitive function, assessed using the standardised National Institute of Neurological Disorders & Stroke (NINDS) Assessment battery.
The primary outcome will be used for purposes of estimating the effect size (including standard deviation) to inform a power calculation for estimation of sample size for a definitive trial.
|
Patients will complete these cognitive assessments at three time points: prior to (1) and following (2) the 5-week group based rehabilitation period (or control period), and at four months post-intervention (3).
|
Symbol Digit Modalities Test (National Institute of Neurological Disorders & Stroke (NINDS) Assessment Battery)
Time Frame: Patients will complete these cognitive assessments at three time points: prior to (1) and following (2) the 5-week group based rehabilitation period (or control period), and at four months post-intervention (3).
|
The primary outcome is cognitive function, assessed using the standardised National Institute of Neurological Disorders & Stroke (NINDS) Assessment battery.
The primary outcome will be used for purposes of estimating the effect size (including standard deviation) to inform a power calculation for estimation of sample size for a definitive trial.
|
Patients will complete these cognitive assessments at three time points: prior to (1) and following (2) the 5-week group based rehabilitation period (or control period), and at four months post-intervention (3).
|
Rey Complex Figure Test copy, immediate/delayed recall, and recognition (National Institute of Neurological Disorders & Stroke (NINDS) Assessment Battery)
Time Frame: Patients will complete these cognitive assessments at three time points: prior to (1) and following (2) the 5-week group based rehabilitation period (or control period), and at four months post-intervention (3).
|
The primary outcome is cognitive function, assessed using the standardised National Institute of Neurological Disorders & Stroke (NINDS) Assessment battery.
The primary outcome will be used for purposes of estimating the effect size (including standard deviation) to inform a power calculation for estimation of sample size for a definitive trial.
|
Patients will complete these cognitive assessments at three time points: prior to (1) and following (2) the 5-week group based rehabilitation period (or control period), and at four months post-intervention (3).
|
Hopkins Verbal Learning Test - immediate/delayed recall, & recognition (National Institute of Neurological Disorders & Stroke (NINDS) Assessment Battery)
Time Frame: Patients will complete these cognitive assessments at three time points: prior to (1) and following (2) the 5-week group based rehabilitation period (or control period), and at four months post-intervention (3).
|
The primary outcome is cognitive function, assessed using the standardised National Institute of Neurological Disorders & Stroke (NINDS) Assessment battery.
The primary outcome will be used for purposes of estimating the effect size (including standard deviation) to inform a power calculation for estimation of sample size for a definitive trial.
|
Patients will complete these cognitive assessments at three time points: prior to (1) and following (2) the 5-week group based rehabilitation period (or control period), and at four months post-intervention (3).
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Goal Attainment Scaling based on SEIQoL (Self-efficacy in managing cognitive deficits)
Time Frame: Patients will complete these cognitive assessments at three time points: prior to (1) and following (2) the 5-week group based rehabilitation period (or control period), and at four months post-intervention (3).
|
A major secondary outcome is patient-reported self-efficacy in managing their cognitive deficits. Additionally, personal and demographic details will be recorded for each patient. Mood, functional ability, quality of life (QoL), adherence, and recurrent stroke will be assessed as important secondary outcome measures. |
Patients will complete these cognitive assessments at three time points: prior to (1) and following (2) the 5-week group based rehabilitation period (or control period), and at four months post-intervention (3).
|
Modified Stroke Self-Efficacy Scale (Self-efficacy in managing cognitive deficits)
Time Frame: Patients will complete these cognitive assessments at three time points: prior to (1) and following (2) the 5-week group based rehabilitation period (or control period), and at four months post-intervention (3).
|
A major secondary outcome is patient-reported self-efficacy in managing their cognitive deficits. Additionally, personal and demographic details will be recorded for each patient. Mood, functional ability, quality of life (QoL), adherence, and recurrent stroke will be assessed as important secondary outcome measures. |
Patients will complete these cognitive assessments at three time points: prior to (1) and following (2) the 5-week group based rehabilitation period (or control period), and at four months post-intervention (3).
|
Test of Premorbid Functioning
Time Frame: Patients will complete these cognitive assessments at three time points: prior to (1) and following (2) the 5-week group based rehabilitation period (or control period), and at four months post-intervention (3).
|
A major secondary outcome is patient-reported self-efficacy in managing their cognitive deficits. Additionally, personal and demographic details will be recorded for each patient. Mood, functional ability, quality of life (QoL), adherence, and recurrent stroke will be assessed as important secondary outcome measures. |
Patients will complete these cognitive assessments at three time points: prior to (1) and following (2) the 5-week group based rehabilitation period (or control period), and at four months post-intervention (3).
|
Wechsler Abbreviated Scale of Intelligence
Time Frame: Patients will complete these cognitive assessments at three time points: prior to (1) and following (2) the 5-week group based rehabilitation period (or control period), and at four months post-intervention (3).
|
A major secondary outcome is patient-reported self-efficacy in managing their cognitive deficits. Additionally, personal and demographic details will be recorded for each patient. Mood, functional ability, quality of life (QoL), adherence, and recurrent stroke will be assessed as important secondary outcome measures. |
Patients will complete these cognitive assessments at three time points: prior to (1) and following (2) the 5-week group based rehabilitation period (or control period), and at four months post-intervention (3).
|
Fatigue Severity Scale
Time Frame: Patients will complete these cognitive assessments at three time points: prior to (1) and following (2) the 5-week group based rehabilitation period (or control period), and at four months post-intervention (3).
|
A major secondary outcome is patient-reported self-efficacy in managing their cognitive deficits. Additionally, personal and demographic details will be recorded for each patient. Mood, functional ability, quality of life (QoL), adherence, and recurrent stroke will be assessed as important secondary outcome measures. |
Patients will complete these cognitive assessments at three time points: prior to (1) and following (2) the 5-week group based rehabilitation period (or control period), and at four months post-intervention (3).
|
General Anxiety Disorder 7-item assessment
Time Frame: Patients will complete these cognitive assessments at three time points: prior to (1) and following (2) the 5-week group based rehabilitation period (or control period), and at four months post-intervention (3).
|
A major secondary outcome is patient-reported self-efficacy in managing their cognitive deficits. Additionally, personal and demographic details will be recorded for each patient. Mood, functional ability, quality of life (QoL), adherence, and recurrent stroke will be assessed as important secondary outcome measures. |
Patients will complete these cognitive assessments at three time points: prior to (1) and following (2) the 5-week group based rehabilitation period (or control period), and at four months post-intervention (3).
|
Patient Health Questionnaire
Time Frame: Patients will complete these cognitive assessments at three time points: prior to (1) and following (2) the 5-week group based rehabilitation period (or control period), and at four months post-intervention (3).
|
A major secondary outcome is patient-reported self-efficacy in managing their cognitive deficits. Additionally, personal and demographic details will be recorded for each patient. Mood, functional ability, quality of life (QoL), adherence, and recurrent stroke will be assessed as important secondary outcome measures. |
Patients will complete these cognitive assessments at three time points: prior to (1) and following (2) the 5-week group based rehabilitation period (or control period), and at four months post-intervention (3).
|
Modified Rankin Scale
Time Frame: Patients will complete these cognitive assessments at three time points: prior to (1) and following (2) the 5-week group based rehabilitation period (or control period), and at four months post-intervention (3).
|
A major secondary outcome is patient-reported self-efficacy in managing their cognitive deficits. Additionally, personal and demographic details will be recorded for each patient. Mood, functional ability, quality of life (QoL), adherence, and recurrent stroke will be assessed as important secondary outcome measures. |
Patients will complete these cognitive assessments at three time points: prior to (1) and following (2) the 5-week group based rehabilitation period (or control period), and at four months post-intervention (3).
|
Patient Health Questionnaire (Family member/carer outcome)
Time Frame: Carers/family members will complete these assessments at three time points: prior to (1) and following (2) the 5-week group based rehabilitation period (or control period), and at four months post-intervention (3).
|
The patient's family member/carer will be asked to complete a relative/carer assessment.
|
Carers/family members will complete these assessments at three time points: prior to (1) and following (2) the 5-week group based rehabilitation period (or control period), and at four months post-intervention (3).
|
General Anxiety Disorder 7-item assessment (Family member/carer outcome)
Time Frame: Carers/family members will complete these assessments at three time points: prior to (1) and following (2) the 5-week group based rehabilitation period (or control period), and at four months post-intervention (3).
|
The patient's family member/carer will be asked to complete a relative/carer assessment.
|
Carers/family members will complete these assessments at three time points: prior to (1) and following (2) the 5-week group based rehabilitation period (or control period), and at four months post-intervention (3).
|
Vulnerable Elders Survey (Family member/carer outcome)
Time Frame: Carers/family members will complete these assessments at three time points: prior to (1) and following (2) the 5-week group based rehabilitation period (or control period), and at four months post-intervention (3).
|
The patient's family member/carer will be asked to complete a relative/carer assessment.
|
Carers/family members will complete these assessments at three time points: prior to (1) and following (2) the 5-week group based rehabilitation period (or control period), and at four months post-intervention (3).
|
Zarit Burden Interview (Family member/carer outcome)
Time Frame: Carers/family members will complete these assessments at three time points: prior to (1) and following (2) the 5-week group based rehabilitation period (or control period), and at four months post-intervention (3).
|
The patient's family member/carer will be asked to complete a relative/carer assessment.
|
Carers/family members will complete these assessments at three time points: prior to (1) and following (2) the 5-week group based rehabilitation period (or control period), and at four months post-intervention (3).
|
Perceived Stress Scale (Family member/carer outcome)
Time Frame: Carers/family members will complete these assessments at three time points: prior to (1) and following (2) the 5-week group based rehabilitation period (or control period), and at four months post-intervention (3).
|
The patient's family member/carer will be asked to complete a relative/carer assessment.
|
Carers/family members will complete these assessments at three time points: prior to (1) and following (2) the 5-week group based rehabilitation period (or control period), and at four months post-intervention (3).
|
Informant Questionnaire for Cognitive Decline in the Elderly, short form (Family member/carer outcome)
Time Frame: Carers/family members will complete these assessments at three time points: prior to (1) and following (2) the 5-week group based rehabilitation period (or control period), and at four months post-intervention (3).
|
The patient's family member/carer will be asked to complete a relative/carer assessment.
|
Carers/family members will complete these assessments at three time points: prior to (1) and following (2) the 5-week group based rehabilitation period (or control period), and at four months post-intervention (3).
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Eligibility rates (Intervention feasibility)
Time Frame: Through study completion, an average of 1.5 years
|
This study will provide robust evidence to inform a decision to progress to a definitive trial, including eligibility, recruitment, and retention rates, feasibility of randomisation, acceptability to patients, and resource use based on micro-costing of the intervention delivery.
|
Through study completion, an average of 1.5 years
|
Recruitment rates (Intervention feasibility)
Time Frame: Through study completion, an average of 1.5 years
|
This study will provide robust evidence to inform a decision to progress to a definitive trial, including eligibility, recruitment, and retention rates, feasibility of randomisation, acceptability to patients, and resource use based on micro-costing of the intervention delivery.
|
Through study completion, an average of 1.5 years
|
Retention rates (Intervention feasibility)
Time Frame: Through study completion, an average of 1.5 years
|
This study will provide robust evidence to inform a decision to progress to a definitive trial, including eligibility, recruitment, and retention rates, feasibility of randomisation, acceptability to patients, and resource use based on micro-costing of the intervention delivery.
|
Through study completion, an average of 1.5 years
|
Feasibility of Randomisation (Intervention feasibility)
Time Frame: Through study completion, an average of 1.5 years
|
This study will provide robust evidence to inform a decision to progress to a definitive trial, including eligibility, recruitment, and retention rates, feasibility of randomisation, acceptability to patients, and resource use based on micro-costing of the intervention delivery.
|
Through study completion, an average of 1.5 years
|
Resource Use (Microcosting)(Intervention feasibility)
Time Frame: Through study completion, an average of 1.5 years
|
Micro-costing of materials and consumables utilised in the pilot study and the staffing costs and time taken to recruit patients, and costs associated with the usual care comparator will be recorded
|
Through study completion, an average of 1.5 years
|
Qualitative Process Evaluation (Intervention Acceptability)
Time Frame: Through study completion, an average of 1.5 years
|
Qualitative data will be separately collected from patients and staff involved in the intervention in the form of focus group interviews to explore how they experienced the intervention process and to indicate the extent to which it was found to be helpful and/or feasible.
|
Through study completion, an average of 1.5 years
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- StrokeCog-R
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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