The StrokeCog Study: Cognitive Rehabilitation Intervention in Stroke

Stroke Clinical Trial

— StrokeCog-R  

Official title:

The StrokeCog Study: a Randomised Pilot Study of a Novel Cognitive Rehabilitation Intervention in Stroke

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06021470
• Other study ID #: StrokeCog-R
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 2023
• Est. completion date: October 2025

Study information

• Verified date: July 2023
• Source: Royal College of Surgeons, Ireland
• Contact: Anne Hickey, PhD
• Email: ahickey[@]rcsi.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 64
• Est. completion date: October 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cognitive Impairment
• Stroke
• Stroke Sequelae

Intervention

Behavioral:
• Cognitive rehabilitation intervention
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Royal College of Surgeons, Ireland

Outcome

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