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

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. 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.

Conditions

• Ischaemic Stroke
• Cognitive Impairments, Mild

Interventions

OTHER

Cognitive care bundle

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.

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

Sponsors & Collaborators

• National University of Malaysia

  lead OTHER

Principal Investigators

• Zhe Kang Law · National University of Malaysia

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-06-30

Primary Completion

2028-11-30

Completion

2029-04-30

Countries

• Malaysia

Study Locations