Clinical trial NCT06021470: The StrokeCog Study: Cognitive Rehabilitation Intervention in Stroke
Official title: The StrokeCog Study: a Randomised Pilot Study of a Novel Cognitive Rehabilitation Intervention in Stroke
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Stroke
Stroke Sequelae
Cognitive Impairment
Lead sponsor: Royal College of Surgeons, Ireland
Sponsor class: OTHER
First posted: 2023-09-01
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Digit Span forward & backward (National Institute of Neurological Disorders & Stroke (NINDS) Assessment Battery)
timeFrame: 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).
measure: Verbal Fluency (National Institute of Neurological Disorders & Stroke (NINDS) Assessment Battery)
timeFrame: 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).
measure: Colour Trails Tests A&B (National Institute of Neurological Disorders & Stroke (NINDS) Assessment Battery)
timeFrame: 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).
measure: 15-Item modified Boston Naming Test (National Institute of Neurological Disorders & Stroke (NINDS) Assessment Battery)
timeFrame: 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).
measure: Symbol Digit Modalities Test (National Institute of Neurological Disorders & Stroke (NINDS) Assessment Battery)
timeFrame: 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).
measure: Rey Complex Figure Test copy, immediate/delayed recall, and recognition (National Institute of Neurological Disorders & Stroke (NINDS) Assessment Battery)
timeFrame: 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).
measure: Hopkins Verbal Learning Test - immediate/delayed recall, & recognition (National Institute of Neurological Disorders & Stroke (NINDS) Assessment Battery)
timeFrame: 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 outcomes:
measure: Goal Attainment Scaling based on SEIQoL (Self-efficacy in managing cognitive deficits)
timeFrame: 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).
measure: Modified Stroke Self-Efficacy Scale (Self-efficacy in managing cognitive deficits)
timeFrame: 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).
measure: Test of Premorbid Functioning
timeFrame: 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).
measure: Wechsler Abbreviated Scale of Intelligence
timeFrame: 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).
measure: Fatigue Severity Scale
timeFrame: 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).
measure: General Anxiety Disorder 7-item assessment
timeFrame: 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).
measure: Patient Health Questionnaire
timeFrame: 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).
measure: Modified Rankin Scale
timeFrame: 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).
measure: Patient Health Questionnaire (Family member/carer outcome)
timeFrame: 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).
measure: General Anxiety Disorder 7-item assessment (Family member/carer outcome)
timeFrame: 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).
measure: Vulnerable Elders Survey (Family member/carer outcome)
timeFrame: 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).
measure: Zarit Burden Interview (Family member/carer outcome)
timeFrame: 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).
measure: Perceived Stress Scale (Family member/carer outcome)
timeFrame: 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).
measure: Informant Questionnaire for Cognitive Decline in the Elderly, short form (Family member/carer outcome)
timeFrame: 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 outcomes:
measure: Eligibility rates (Intervention feasibility)
timeFrame: Through study completion, an average of 1.5 years
measure: Recruitment rates (Intervention feasibility)
timeFrame: Through study completion, an average of 1.5 years
measure: Retention rates (Intervention feasibility)
timeFrame: Through study completion, an average of 1.5 years
measure: Feasibility of Randomisation (Intervention feasibility)
timeFrame: Through study completion, an average of 1.5 years
measure: Resource Use (Microcosting)(Intervention feasibility)
timeFrame: Through study completion, an average of 1.5 years
measure: Qualitative Process Evaluation (Intervention Acceptability)
timeFrame: Through study completion, an average of 1.5 years
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Study officials:
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