The StrokeCog Study: Cognitive Rehabilitation Intervention in Stroke

NCT06021470 | Unknown

• 1 other identifier: StrokeCog-R
• Study Type: interventional
• Target: 64
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Stroke; Stroke Sequelae; Cognitive Impairment

Outcome Measures

Primary Outcomes (7)

• 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).

• 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).

• 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).

• 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).

• 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).

• 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).

• 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 Outcomes (14)

• 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).

• 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).

• 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).

• 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).

• 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).

Other Outcomes (6)

• Eligibility rates (Intervention feasibility)

  Through study completion, an average of 1.5 years

• Recruitment rates (Intervention feasibility)

  Through study completion, an average of 1.5 years

• Retention rates (Intervention feasibility)

  Through study completion, an average of 1.5 years

Study Arms (2)

Cognitive rehabilitation intervention arm

EXPERIMENTAL

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.

Behavioral: Cognitive rehabilitation intervention

Usual care

NO INTERVENTION

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.

Interventions

Cognitive rehabilitation intervention BEHAVIORAL

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.

Cognitive rehabilitation intervention arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Royal College of Surgeons, Ireland: lead

MeSH Terms

Conditions

Stroke; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Anne Hickey, PhD

CONTACT

ahickey@rcsi.com

Niamh Corbett, MA

CONTACT

0872051887; niamhcorbett@rcsi.ie

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The Research Fellow conducting neuropsychological assessments will be blinded to random allocation and will not be involved in delivering the intervention. The neuropsychologist clinician will deliver the intervention and will not be involved in assessment or data analysis. The objective measures of cognition collected during the neuropsychological assessments are less subject to response bias than subjective assessments as patients cannot be blinded to treatment allocation; at post-assessment, patients will be asked not to reveal whether they have received the intervention or not in order to maximise researcher blinding.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2023
• First Posted: September 1, 2023
• Study Start: August 1, 2023
• Primary Completion: May 1, 2025
• Study Completion: October 1, 2025
• Last Updated: September 1, 2023

Record last verified: 2023-07