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

APPLICATION OF COGNITIVE CARE BUNDLE TO ISCHAEMIC STROKE PATIENTS AND ITS EFFECT ON POST-STROKE COGNITIVE OUTCOME: A PILOT RANDOMISED CONTROLLED TRIAL

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. 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. Do people who receive the cognitive care bundle have better cognitive scores 3 months after their stroke, compared to those who receive standard care?

Researchers will compare two groups of stroke survivors. One group will receive the cognitive care bundle plus standard medical care. The other group will receive standard medical care alone. This comparison will help researchers see if the care bundle works better to prevent cognitive decline.

Participants in the intervention (care bundle) group will:

Check and record their blood pressure daily at home (and their blood sugar too, if they have diabetes). Talk with a doctor weekly over the phone to review their readings and adjust medications if needed

See a dietitian for a personalized eating plan

Have a hearing test by an audiologist

Have a basic vision test by the research team

Answer a short questionnaire about their mood to screen for depression

All participants (in both groups) will undergo physiotherapy and cognitive training. Participants will be followed up with blood tests, examination by a doctor and questionnaires after 3 months.

This is a pilot study to see if this approach works and is practical to do in a larger future study.

Study Overview

• Status: Not yet recruiting
• Conditions: Ischaemic Stroke; Cognitive Impairments, Mild
• Intervention / Treatment: Other: Cognitive care bundle; Other: Standard Medical Care (SMC)

Detailed Description

Study Design Overview

This is a single-centre, pilot prospective randomised open-label, blinded end-point (PROBE) controlled trial. The study aims to evaluate the feasibility, adherence, and preliminary efficacy of a multi-domain cognitive care bundle in preventing post-stroke cognitive impairment (PSCI) among patients with acute ischemic stroke.

Rationale

Post-stroke cognitive impairment affects up to 60% of stroke survivors within the first year and is associated with poorer functional outcomes, reduced rehabilitation potential, and increased long-term risk of dementia. Despite identification of several modifiable risk factors-including hypertension, hyperglycaemia, malnutrition, sensory impairments (visual and hearing loss), and post-stroke depression-there is limited real-world evidence that systematic optimisation of these factors improves cognitive outcomes. This study will test a bundled intervention targeting these modifiable domains.

Study Setting

The trial will be conducted at Hospital Canselor Tuanku Muhriz (HCTM), Universiti Kebangsaan Malaysia, a tertiary academic medical centre. Recruitment will occur from the acute stroke ward and neurology clinic.

Participant Timeline

Screening and enrolment: Within 7 days of ischemic stroke onset

Baseline assessment: Montreal Cognitive Assessment (MoCA), Ascertain Dementia 8 (AD-8), Hospital Anxiety and Depression Scale (HADS), modified Rankin Scale (mRS), and EQ-5D-5L

Intervention period: From hospital discharge to 3 months post-stroke

Follow-up assessment: At 3 months post-stroke (primary timepoint), conducted by a blinded rater

Intervention Description

Participants randomised to the intervention arm will receive standard medical therapy plus a cognitive care bundle consisting of six components:

Home blood pressure (BP) monitoring: Daily BP measurement using a provided home device, with target BP <130/80 mmHg. Readings recorded on a standardised logsheet. Weekly teleconsultation with the study investigator; if ≥3 of 7 readings are above target, antihypertensive medication adjustment will be considered (prescriptions issued as needed).

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.

Dietitian referral: All intervention participants receive a referral to a clinical dietitian for comprehensive nutritional assessment, individualised dietary advice, and optimisation of feeding regimes (including for those with dysphagia or enteral tube feeding). Nutritional deficiencies will be screened and managed.

Vision screening: Bedside assessment using Snellen chart and confrontational visual field testing by the research team. Participants with detected visual impairment will be referred to the ophthalmology clinic for formal evaluation and management.

Hearing assessment: Referral to audiology for formal hearing evaluation using pure-tone audiometry. Appropriate management (e.g., hearing aids) will be arranged as indicated.

Depression screening: Administration of the Hospital Anxiety and Depression Scale (HADS) prior to discharge. Participants with HADS-depression subscore ≥8 (indicating probable depression) will be referred to psychiatrist or psychological services for further assessment and treatment.

Control Arm

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.

Randomisation and Blinding

Eligible participants will be randomised 1:1 to intervention or control using a blocked randomisation list (block size variable, concealed). Stratification factors: age (≥65 years vs. <65 years) and baseline MoCA score (18-21 vs. 22-25). The randomisation sequence will be generated using Sealed Envelope (https://www.sealedenvelope.com) and kept by an independent person not involved in enrolment or outcome assessment.

The study is open-label for participants and investigators delivering the intervention. However, outcome assessors at 3 months will be blinded to treatment allocation. The primary analyses will be conducted on an intention-to-treat basis.

Data Collection and Management

Data will be collected using standardised case report forms (CRFs) at baseline and 3 months. Source documents include medical records, participant-completed logs (BP and glucose), teleconsultation records, and specialist referral outcomes. Hard-copy CRFs will be stored in locked cabinets; data will be entered into SPSS (Version 29.0) with password-encrypted files. Participant identities will be coded and not traceable in the analytical dataset.

Feasibility Outcomes (Primary)

Feasibility will be assessed by:

Adherence rate to the cognitive care bundle (proportion of participants completing ≥80% of scheduled weekly teleconsultations and home monitoring logs)

Proportion of participants requiring medication adjustments during weekly reviews

Proportion of participants successfully referred to and attending dietitian, ophthalmology, audiology, and psychiatry/psychology services

Clinical Outcomes (Secondary)

Cognitive function: MoCA score (range 0-30, higher better) and AD-8 score (range 0-8, score ≥2 indicates cognitive impairment) at 3 months

BP control (systolic and diastolic BP at 3 months)

Glycaemic control (HbA1c at 3 months)

Functional status: modified Rankin Scale (mRS) at 3 months

Mood: HADS score (anxiety and depression subscores) at 3 months

Quality of life: EQ-5D-5L index value and visual analogue scale (VAS) at 3 months

Sample Size Justification

Based on Whitehead et al. (2016) and Teresi et al. recommendations for pilot feasibility studies, a sample size of 25 participants per arm (total N=50) is adequate to estimate feasibility parameters and provide a small effect size (standardised effect size 0.2) for preliminary efficacy. This sample size is appropriate for a pilot trial designed to inform a future definitive randomised controlled trial.

Statistical Analysis Plan

Descriptive statistics will be used to summarise baseline characteristics and feasibility outcomes. Categorical variables presented as frequencies (percentages); continuous variables as mean (SD) or median (IQR) based on normality. Between-group comparisons at 3 months will be performed using:

Chi-square test (or Fisher's exact) for binary outcomes (e.g., proportion with MoCA <26)

Independent t-test (or Mann-Whitney U test) for continuous outcomes (MoCA, HbA1c, BP, HADS, EQ-5D-5L)

Ordinal logistic regression for mRS (ordinal outcome)

Multivariable regression will adjust for prespecified confounders (age, baseline MoCA, and any baseline variable with p<0.10 on univariate analysis). Two-tailed p<0.05 will be considered statistically significant. All analyses will be performed using SPSS Version 29.0.

Data Monitoring

Periodic data monitoring will be conducted by a researcher independent of the study team to verify that CRF data match source documents. Given the low-risk nature of the intervention (behavioural and monitoring interventions with no investigational drug or device), no independent Data Safety Monitoring Board (DSMB) is planned. Serious adverse events will be reported to the Principal Investigator within 24 hours and to the UKM Research Ethics Committee as per institutional policy.

Ethics and Dissemination

The study has received approval from the Universiti Kebangsaan Malaysia Research Ethics Committee (approval number to be JEP-2026-144). Written informed consent will be obtained from all participants or their legal guardians.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zhe Kang Law, MD, PhD; Phone Number: 6936 +6091455555; Email: zhe.kanglaw@hctm.ukm.edu.my

Study Locations

• Malaysia
  • Kuala Lumpur
    • Kuala Lumpur, Kuala Lumpur, Malaysia, 56000
      • Hospital Canselor Tuanku Muhriz UKM
      • Contact: Zhe Kang Law, MD, PhD; Phone Number: 6936 +60391455555; Email: zhe.kanglaw@hctm.ukm.edu.my
      • Contact: Aina Salihah Shahruniza, MBBS; Email: ainasalihah@gmail.com
      • Sub-Investigator: Aina Salihah Shahruniza, MBBS
      • Principal Investigator: Zhe Kang Law, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cognitive care bundle; Care bundle consisting: daily home blood pressure and glycaemic monitoring with weekly physician-led telephone follow up and medication adjustment; screening for visual impairment with referral if indicated; audiology test with referral if indicated; dietitian referral; 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; Care bundle consisting: 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.; 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.; screening for visual impairment with referral if indicated; audiology test with referral if indicated; dietitian referral; screening for post-stroke depression with referral to psychiatrist if indicated Patients will receive cognitive training and physiotherapy as part of standard medical care.
Active Comparator: Standard Medical Care; 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); 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cognitive impairment	MoCA score < 26 or AD-8 score > 2	3 months
Functional outcome	modified Rankin Scale 0-2	3 months
Blood pressure control	Clinic blood pressure measurement, average of 2 measurements	3 months
Glycaemic control	HbA1c	3 months
Quality of life score	Euro-QoL-5D-5L	3 months
Anxiety and depression	Hospital Anxiety and Depression scale	3 months

Collaborators and Investigators

• Sponsor: National University of Malaysia
• Investigators: Principal Investigator: Zhe Kang Law, National University of Malaysia

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): April 1, 2029

Study Registration Dates

• First Submitted: May 20, 2026
• First Submitted That Met QC Criteria: May 20, 2026
• First Posted (Actual): May 27, 2026

Study Record Updates

• Last Update Posted (Actual): May 27, 2026
• Last Update Submitted That Met QC Criteria: May 20, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: post-stroke cognitive impairment, care bundle, pilot, intervention, cognitive rehab, blood pressure, hyperglycaemia
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Mental Disorders; Metabolic Diseases; Neurocognitive Disorders; Glucose Metabolism Disorders; Cognition Disorders; Stroke; Nutritional and Metabolic Diseases; Ischemic Stroke; Cognitive Dysfunction; Hyperglycemia
• Other Study ID Numbers: 1.0 4th May 2026; GP-K019817, FF-2026-180 (Other Grant/Funding Number: National University of Malaysia)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: After the publication of the primary result paper, IPD can be shared upon request to the principal investigator
• IPD Sharing Time Frame: From Jan 2030.
• IPD Sharing Access Criteria: Request can be made to the principal investigator for study dataset.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No