NCT06088212招募中不适用
Reducing Cognitive Impairment by Management of Heart Failure as a Modifiable Risk Factor: the Cog-HF Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 168
- 试验地点
- 2
- 主要终点
- Change in MOCA score
研究概览
简要总结
This study will test the feasibility and effectiveness of an innovative model of care for cognitively impaired patients with heart failure. This program aims to improve cognition, reduce dementia risk and cardiovascular events, and will be supported by innovative digital technology for wide scale rollout and implementation. Findings from this research will transform the way healthcare is delivered to cognitively impaired patients with heart disease who have a very high risk of developing dementia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
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
- •Hospitalised with HF as primary or secondary diagnosis.
- •At least mild cognitive impairment (CI) based on Montreal Cognitive Assessment (MoCA) on hospital discharge.
排除标准
- •Unable to provide written consent; requiring palliative care; or participating in another RCT
- •Recovery of cognitive function shortly after hospital discharge: to ensure that we only include patients with "true" CI, any patients with a repeated MoCA>25 at 2 weeks post-discharge will be excluded.
- •Terminal illness (eg. cancer) that may influence 12-month prognosis.
结局指标
主要结局
Change in MOCA score
时间窗: 12 months
Greater Montreal Cognitive Assessment (MOCA) score (ranging 0-30) is better
次要结局
- Change in hand grip strength(12 and 24 months)
- Change in 6-minute walk distance(12 and 24 months)
- Change in cardiac function(12 months)
- Change in quality of life(12 and 24 months)
- Change in MOCA score(24 months)
- Change in heart failure classification(12 and 24 months)
- Change in brain volume via MRI measurement(24 months)
研究者
研究点 (2)
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