COGnitive Care Bundle for Ischaemic Stroke : a Pilot Randomised Controlled Trial

NCT07610291 | Not Yet Recruiting DMC

• 2 other identifiers: 1.0 4th May 2026GP-K019817, FF-2026-180
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn if a set of treatments, called a "cognitive care bundle," can help preserve cognitive ability in people who have had a stroke. This study will also test how feasible it is for people to follow this care bundle. The main questions it aims to answer are:

1. 1.Do people find it feasible to follow the care bundle, which includes daily home blood pressure checks (and blood sugar checks for those with diabetes), along with referrals to specialists like dietitians, eye doctors, hearing specialists, and mental health professionals?
2. 2.Do people who receive the cognitive care bundle have better cognitive scores 3 months after their stroke, compared to those who receive standard care?

Conditions

Ischaemic Stroke; Cognitive Impairments, Mild

Keywords

post-stroke cognitive impairment, care bundle, pilot, intervention, cognitive rehab, blood pressure, hyperglycaemia

Outcome Measures

Primary Outcomes (1)

• Feasibility: the adherence rate to the cognitive care bundle

  Proportions of patients who adhere to weekly follow-up of blood pressure and blood glucose and change in medications, proportions of patients referred to dietitians, ophthalmologists, audiologists and psychiatrists in both groups.

  3 months

Secondary Outcomes (6)

• Cognitive impairment

  3 months

• Functional outcome

  3 months

• Blood pressure control

  3 months

• Glycaemic control

  3 months

• Quality of life score

  3 months

Study Arms (2)

Cognitive care bundle

EXPERIMENTAL

Care bundle consisting: 1. daily home blood pressure and glycaemic monitoring with weekly physician-led telephone follow up and medication adjustment 2. screening for visual impairment with referral if indicated 3. audiology test with referral if indicated 4. dietitian referral 5. screening for post-stroke depression with referral to psychiatrist if indicated Patients will receive cognitive training and physiotherapy as part of standard medical care.

Other: Cognitive care bundle

Standard Medical Care

ACTIVE COMPARATOR

blood pressure and glycaemic monitoring with regular clinic follow-up, dietitian referral for patients needing nasogastric feeding only, cognitive training and physiotherapy as part of standard medical care.

Other: Standard Medical Care (SMC)

Interventions

Cognitive care bundle OTHER

Care bundle consisting: 1. Home blood pressure (BP) monitoring: Daily BP measurement using a provided home device, with target BP \<130/80 mmHg. Weekly teleconsultation with the study investigator; if ≥3 of 7 readings are above target, antihypertensive medication adjustment will be considered. 2. Home blood glucose monitoring (for participants with diabetes mellitus): Daily fasting and random capillary glucose measurement using a provided glucometer. Target ranges: fasting 4.4-7.0 mmol/L, random 4.4-8.5 mmol/L. Weekly review during teleconsultation; medication adjustment if ≥3 of 7 readings are out of range. 3. screening for visual impairment with referral if indicated 4. audiology test with referral if indicated 5. dietitian referral 6. screening for post-stroke depression with referral to psychiatrist if indicated Patients will receive cognitive training and physiotherapy as part of standard medical care.

Cognitive care bundle

Standard Medical Care (SMC) OTHER

Participants in the control arm will receive standard medical therapy as per local clinical practice guidelines. This includes routine blood pressure and glucose monitoring (in clinic), physiotherapy referral, dietitian referral only for nasogastric tube-fed patients, risk factor screening, and cognitive screening with referral to cognitive therapy if clinically indicated. No weekly teleconsultation or proactive home monitoring is provided

Standard Medical Care

Eligibility Criteria

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

You may qualify if:

• Age 18 years old or older
• Diagnosis of ischemic stroke within 7 days
• Mild cognitive impairment noted during admission of stroke (MoCA 18-25)

You may not qualify if:

• GCS \<8
• Pre-stroke neurodegenerative disease (Parkinson's, Alzheimer's, Vascular Dementia, Frontotemporal Dementia, Mixed Dementia, Lewy Body Dementia)
• Patient with previous stroke
• Modified Rankin Scale of 4 and above
• Known psychiatric disorder
• Patient on psychotherapy medications (benzodiazepine, antidepressant, etc)
• Severe aphasia
• Logistical issues hindering follow up
• Delirium

Sponsors & Collaborators

• National University of Malaysia: lead

Study Sites (1)

Hospital Canselor Tuanku Muhriz UKM

Kuala Lumpur, Kuala Lumpur, 56000, Malaysia

Location

MeSH Terms

Conditions

Ischemic Stroke; Cognitive Dysfunction; Hyperglycemia

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Zhe Kang Law

  National University of Malaysia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhe Kang Law, MD, PhD

CONTACT

+6091455555; zhe.kanglaw@hctm.ukm.edu.my

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: independent assessor not involved in patient's care will conduct follow-up visit
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2026
• First Posted: May 27, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): April 1, 2029
• Last Updated: May 27, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR, ANALYTIC CODE
• Time Frame: From Jan 2030.
• Access Criteria: Request can be made to the principal investigator for study dataset.

Locations

MY (1)