Efficacy of the CHM Teabag in Decreasing Stroke Risk Among Elderly People in Hong Kong: A Stepped Wedge Cluster Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 912
- 试验地点
- 1
- 主要终点
- Automatic Retinal Image Analysis (ARIA).
研究概览
简要总结
This stepped wedge cluster randomized controlled trial aims to examine the efficacy and safety of CHM teabag in decreasing stroke risk by machine-learning-based retinal image analysis in elderly population.
详细描述
This is a stepped wedge cluster randomized controlled trial design. This study aims to examine the efficacy and safety of CHM teabag in decreasing stroke risk by machine-learning-based retinal image analysis in elderly population.
A total of 912 participants will be recruited from 9 clinics. 2~3 clinics will represent a cluster unit. The stepped wedge design will consist of four groups each containing four randomly allocated cluster units, allocated to either 4, 8, 12, or 16 weeks of the intervention. The intervention is Chinese herbal teabag treatment, which will consist of five Chinese herbs (a total of 10g). The first group will receive 16 weeks of the intervention, the second group will receive 12 weeks, the third group will receive 8 weeks, and the forth group will receive 4 weeks.
The primary outcome measure is the stroke risk estimated with Automatic Retinal Image Analysis (ARIA). Secondary outcome measures include Framingham Stroke Risk Score (FSRS), cognitive impairment risk estimated with ARIA, Hong Kong version of the Montreal Cognitive Assessment (MoCA), Constitution in Chinese Medicine Questionnaire (CCMQ), World Health Organization Quality-of-Life Scale (WHOQOL-BREF), Health-promoting lifestyle profile II (HPLP-II), and adverse events.
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
- Single (Outcomes Assessor)
盲法说明
In this stepped wedge design trial, the participants will be aware of the transition from no intervention period to intervention period, therefore it is unlikely to blind participants. Outcome assessors will be blinded to reduce the introduction of bias into the assessments.
入排标准
- 年龄范围
- 54 Years 至 84 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 54-84y.
- •With phlegm dampness constitution and blood stasis constitution on the TCM constitution test table.
- •Stable vital signs without previous history of stroke.
- •Sufficient sensorimotor and language competency for completing assessments.
排除标准
- •Allergic history to Chinese herbal drugs or a known allergy to the ingredients of the teabag.
- •Taking any anticoagulants, such as warfarin.
- •With unconsciousness, aphasia, and cognitive dysfunction.
- •With a past history of brain diseases (e.g., mental illness, consciousness disorder due to head trauma, previous brain surgery, or spastic disease).
- •With severe heart, liver, or kidney disease or bleeding disorders.
- •With other serious diseases.
- •Cataracts or other eye diseases that affected retinal image taking.
- •Distressed with a flashlight or have experience with photosensitive seizures.
- •Pregnancy or lactation female.
- •Any physical examination findings, or history of any illness, or concomitant medications that, in the opinion of the study investigator, might not be suitable to participate in the study.
研究组 & 干预措施
Chinese Herbal Medicine (CHM) teabag, Cluster 1
Intervention Cluster 1 is the first intervention arm designed to examine the efficacy and safety of CHM teabag in decreasing stroke risk by machine-learning-based retinal image analysis in elderly population. It will receive 16 weeks of the intervention.
干预措施: Chinese Herbal Medicine (CHM) teabag (Drug)
CHM teabag, Cluster 2
Intervention Cluster 2 is the second intervention arm designed to examine the efficacy and safety of CHM teabag in decreasing stroke risk by machine-learning-based retinal image analysis in elderly population. It will receive 12 weeks of the intervention.
干预措施: Chinese Herbal Medicine (CHM) teabag (Drug)
CHM teabag, Cluster 3
Intervention Cluster 3 is the third intervention arm designed to examine the efficacy and safety of CHM teabag in decreasing stroke risk by machine-learning-based retinal image analysis in elderly population. It will receive 8 weeks of the intervention.
干预措施: Chinese Herbal Medicine (CHM) teabag (Drug)
CHM teabag, Cluster 4
Intervention Cluster 4 is the fourth intervention arm designed to examine the efficacy and safety of CHM teabag in decreasing stroke risk by machine-learning-based retinal image analysis in elderly population. It will receive 4 weeks of the intervention.
干预措施: Chinese Herbal Medicine (CHM) teabag (Drug)
结局指标
主要结局
Automatic Retinal Image Analysis (ARIA).
时间窗: 16 weeks
The primary outcome will be the score change of stroke risk estimated with Automatic Retinal Image Analysis (ARIA). The ARIA stroke risk score is represented by a probability score which is from 0 to 1. Low risk score is less than 0.5. Moderate score is 0.5 - 0.7. High risk score is more than 0.7.
次要结局
- Adverse events(16 weeks)
- Montreal Cognitive Assessment (MoCA)(16 weeks)
- Framingham Stroke Risk Score (FSRS)(16 weeks)
- Cognitive impairment risk(16 weeks)
- Constitution in Chinese Medicine Questionnaire (CCMQ)(16 weeks)
- World Health Organization Quality-of-Life Scale (WHOQOL-BREF)(16 weeks)
- Health-promoting lifestyle profile II (HPLP-II)(16 weeks)
研究者
ZhaoXiang Bian
Professor
Hong Kong Baptist University