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NCT07610291Not yet recruiting

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

Application of Cognitive Care Bundle to Ischaemic Stroke Patients and Its Effect on Post-Stroke Cognitive Outcome: A Pilot Randomised Controlled Trial

Source: ClinicalTrials.gov · Last updated 13 Jul 2026

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
50 (estimated)
First submitted
20 May 2026
Start date
Jun 2026
Primary completion date
Nov 2028
Lead sponsor
National University of Malaysia
Diseases
Stroke
NCT number
NCT07610291

What you commit to

  • Study type: Interventional
  • Planned participants: 50
  • From Jun 2026 to the primary completion date, Nov 2028
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Patient with previous stroke
  • Patient on psychotherapy medications (benzodiazepine, antidepressant, etc)

Other illness

  • Pre-stroke neurodegenerative disease (Parkinson's, Alzheimer's, Vascular Dementia, Frontotemporal Dementia, Mixed Dementia, Lewy Body Dementia)
  • Known psychiatric disorder

Other

  • GCS \<8
  • Modified Rankin Scale of 4 and above
  • Severe aphasia
  • Logistical issues hindering follow up
  • Delirium

Who the study is looking for

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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Hospital Canselor Tuanku Muhriz UKM
Coordinator of this site? Confirm its status
Kuala LumpurMalaysiaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.