The StrokeCog Study: Cognitive Rehabilitation Intervention in Stroke

Not Applicable

Not yet recruiting

• Conditions: Stroke Sequelae; Stroke; Cognitive Impairment
• Interventions: Behavioral: Cognitive rehabilitation intervention

• Registration Number: NCT06021470
• Lead Sponsor: Royal College of Surgeons, Ireland

Brief Summary

This study aims to progress to the next stage of feasibility testing, by conducting a pilot randomised controlled study with consecutive stroke patients who have mild to moderate cognitive impairment following stroke. The primary focus of the proposed randomised pilot RCT is on recruitment and retention of patients in the intervention, and follow-up assessments. The researchers will also investigate outcomes associated with the intervention and the anticipated effect size for powering a larger trial, with a focus on the feasibility of implementing the intervention in a future definitive randomised controlled trial. The researchers will also carry out a study within a trial (SWAT), comparing recruitment and retention rates across acute, rehabilitation and chronic stroke settings.

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 Timeline

• Status Verified: 2023-07
• Study First Submitted: 2023-07-26
• Study Start: 2023-08
• Study First Submitted QC: 2023-08-29
• Last Update Submitted: 2023-08-29
• Study First Posted: 2023-09-01
• Last Update Posted: 2023-09-01
• Primary Completion: 2025-05
• Study Completion: 2025-10

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

1. 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);
2. First-ever and recurrent stroke;
3. Age 18 and over (no upper age limit);
4. Community dwelling (i.e., normal place of residence is not in a long-term care facility)
5. Is a resident in the Republic of Ireland
6. Capable of providing informed consent

Exclusion Criteria

1. Transient ischaemic attack;
2. Aphasia;
3. Poor English language ability;
4. Nursing home resident;
5. Dementia or severe cognitive impairment;
6. Neurodegenerative disorder;
7. Current psychiatric disorder (as defined by DSM-V or ICD-II criteria);
8. Terminal illness.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cognitive rehabilitation intervention arm	Cognitive rehabilitation intervention	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.

Primary Outcome Measures

Name	Time	Method
Symbol Digit Modalities Test (National Institute of Neurological Disorders & Stroke (NINDS) Assessment Battery)	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.
Verbal Fluency (National Institute of Neurological Disorders & Stroke (NINDS) Assessment Battery)	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.
15-Item modified Boston Naming Test (National Institute of Neurological Disorders & Stroke (NINDS) Assessment Battery)	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.
Colour Trails Tests A&B (National Institute of Neurological Disorders & Stroke (NINDS) Assessment Battery)	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.
Digit Span forward & backward (National Institute of Neurological Disorders & Stroke (NINDS) Assessment Battery)	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.
Rey Complex Figure Test copy, immediate/delayed recall, and recognition (National Institute of Neurological Disorders & Stroke (NINDS) Assessment Battery)	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.
Hopkins Verbal Learning Test - immediate/delayed recall, & recognition (National Institute of Neurological Disorders & Stroke (NINDS) Assessment Battery)	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.

Secondary Outcome Measures

Name	Time	Method
Perceived Stress Scale (Family member/carer outcome)	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.
Fatigue Severity Scale	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.
General Anxiety Disorder 7-item assessment	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.
Vulnerable Elders Survey (Family member/carer outcome)	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.
Test of Premorbid Functioning	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.
Patient Health Questionnaire	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.
Goal Attainment Scaling based on SEIQoL (Self-efficacy in managing cognitive deficits)	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.
Wechsler Abbreviated Scale of Intelligence	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.
Modified Stroke Self-Efficacy Scale (Self-efficacy in managing cognitive deficits)	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.
Modified Rankin Scale	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.
Patient Health Questionnaire (Family member/carer outcome)	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.
Informant Questionnaire for Cognitive Decline in the Elderly, short form (Family member/carer outcome)	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.
General Anxiety Disorder 7-item assessment (Family member/carer outcome)	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.
Zarit Burden Interview (Family member/carer outcome)	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.