Application of Cognitive Care Bundle to Ischaemic Stroke Patients and Its Effect on Post-Stroke Cognitive Outcome: A Pilot Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
研究概览
简要总结
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:
- 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?
- 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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
independent assessor not involved in patient's care will conduct follow-up visit
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years old or older
- •Diagnosis of ischemic stroke within 7 days
- •Mild cognitive impairment noted during admission of stroke (MoCA 18-25)
排除标准
- •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
- •Known psychiatric disorder
- •Patient on psychotherapy medications (benzodiazepine, antidepressant, etc)
- •Severe aphasia
- •Logistical issues hindering follow up
研究组 & 干预措施
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.
干预措施: Cognitive care bundle (Other)
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.
干预措施: Standard Medical Care (SMC) (Other)
结局指标
主要结局
未指定
次要结局
- Cognitive impairment(3 months)
- Quality of life score(3 months)