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Cognitive Care Bundle for Ischaemic Stroke : A Pilot Randomised Controlled Trial

ConditionsIschaemic StrokeCognitive Impairment, Mild
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNational University of Malaysia

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18 years old or older

Diagnosis of ischemic stroke within 7 days

Mild cognitive impairment noted during admission of stroke (MoCA 18-25)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Cognitive care bundle

    Other intervention

    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.

  • Standard Medical Care (SMC)

    Other intervention

    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

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Cognitive care bundleExperimental treatment 1 intervention
Group B: Standard Medical CareActive comparator 1 intervention

Trial outcomes

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.

Time frame
3 months

Secondary outcomes

1

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
2

Functional outcome

modified Rankin Scale 0-2

Time frame
3 months
3

Blood pressure control

Clinic blood pressure measurement, average of 2 measurements

Time frame
3 months
4

Glycaemic control

HbA1c

Time frame
3 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

National University of Malaysia

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: