An interventional study of Cognitive care bundle and Standard Medical Care (SMC) in Ischaemic Stroke and Cognitive Impairment, Mild, sponsored by National University of Malaysia. Not yet recruiting at 1 site in Malaysia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-13.
Sponsored by National University of Malaysia · Not applicable, Interventional, and Treatment
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:
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 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.
2,612 studies on the registry are indexed under Ischemic Stroke; 971 are open to participants now.
This study's planned enrollment of 50 is below the median of 120 across 1,776 interventional studies indexed under Ischemic Stroke.
Browse Ischemic Stroke studies →National University of Malaysia is the lead sponsor of 124 studies on the registry; 45 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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)
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.
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
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.
Time frame: 3 months
Cognitive impairment
Montreal Cognitive Assessment (MoCA) score \< 26 \[range 0 to 30; lower score indicate worse cognition\] or Ascertain Dementia -8 (AD-8) score \> 2 \[range 0 to 8; 0 to 1 normal, 2 or more indicate cognitive impairment likely\]
Time frame: 3 months
Functional outcome
modified Rankin Scale 0-2
Time frame: 3 months
Blood pressure control
Clinic blood pressure measurement, average of 2 measurements
Time frame: 3 months
Glycaemic control
HbA1c
Time frame: 3 months
Quality of life score
European Quality of Life 5 Dimensions 5 Level Version (Euro-QoL-5D-5L) \[range -0.442 to 1; higher score indicating better quality of life\]
Time frame: 3 months
Anxiety and depression
Hospital Anxiety and Depression scale
Time frame: 3 months
Plan to share: Yes — After the publication of the primary result paper, IPD can be shared upon request to the principal investigator
Supporting information: Study protocol, Informed consent form, Clinical study report, Analytic code
Time frame: From Jan 2030.
Access criteria: Request can be made to the principal investigator for study dataset.
No publications or documents are linked to this record.
Start is estimated for Jun 2026; primary completion for Nov 2028, 29 months later.
Of 572 non-industry interventional studies with no phase under Ischemic Stroke, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 48. This study's planned 29 months is close to that.
Counting every sponsor, half of 653 studies reached it within 27 months; a quarter within 14 and three quarters within 48.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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