Elderly, Risk Reduction, Stroke
Conditions
Keywords
Stroke, Risk Reduction, Chinese Herbal Medicine, Automatic Retinal Image Analysis, Teabag
Brief summary
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.
Detailed description
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.
Interventions
DRUGChinese Herbal Medicine (CHM) teabag
Each teabag contains five herbs: Radix et Rhizoma (三七, Sanqi), Moutan Cortex (牡丹皮, Mudanpi), Puerariae Lobatae Radix (葛根, Gegen), Rosae Rugosae Flos (玫瑰花, Meiguihua), and Citri Grandis Exocarpium (化橘紅, Huajuhong). These herbs are benefit to promoting blood circulation, dredging meridians and collaterals, strengthening spleen, regulating qi and decreasing phlegm in Chinese Medicine theories.
Sponsors
Hong Kong Baptist University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
Intervention model description
This is a stepped wedge cluster randomized controlled trial design.
Eligibility
Sex/Gender
ALL
Age
54 Years to 84 Years
Healthy volunteers
Yes
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Automatic Retinal Image Analysis (ARIA). | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cognitive impairment risk | 16 weeks | The severity of WMH changes can be estimated by taking the fundus retinal image and put to the ARIA algorithm, increasing score means increasing severity. |
| Montreal Cognitive Assessment (MoCA) | 16 weeks | The Montreal Cognitive Assessment (MoCA) was designed as a rapid screening instrument for mild cognitive dysfunction. Scoring of HK MoCA ranges from 0 to 30 points. A score of 26 or above is considered normal. |
| Constitution in Chinese Medicine Questionnaire (CCMQ) | 16 weeks | The CCMQ is applied to evaluate body constitution of each patient by score (Balanced Constitution, Qi-deficient Constitution, Yang-deficient Constitution, Yin-deficient Constitution, Phlegm-dampness Constitution, Damp-heat Constitution, Stagnant Blood Constitution, Stagnant Qi Constitution, and Inherited Special Constitution). Each constitution scale contains 6 to 8 items, with 1-5 numerical rating scale. The transformed score of each constitution scale is calculated. |
| Framingham Stroke Risk Score (FSRS) | 16 weeks | The Framingham Stroke Risk Score (FSRS) combines stroke risk factors to predict 10-year probability of stroke. Factors included in the FSRS are age, sex, systolic blood pressure, use of antihypertensive medications, diabetes, smoking, atrial fibrillation, left ventricular hypertrophy and prevalent coronary heart disease. Higher score is associated with higher stroke risk. |
| Health-promoting lifestyle profile II (HPLP-II) | 16 weeks | The Health-Promoting Lifestyle Profile II continues to measure health promoting behavior, conceptualized as a multidimensional pattern of self-initiated actions and perceptions that serve to maintain or enhance the level of wellness, self-actualization and fulfillment of the individual. The total score of the HPLP II ranges from 52 to 208 and is measured by the mean score of the responses to all 52 HPLP items. The total HPLP II score is further classified into four levels: poor for the range 52-90, moderate for the range 91-129, good for the range 130-168, and excellent for the range 169-208. High scores in every subscale mean more frequent health-promoting behaviors. |
| Adverse events | 16 weeks | All adverse events (AEs) will be recorded. |
| World Health Organization Quality-of-Life Scale (WHOQOL-BREF) | 16 weeks | The WHOQOL-BREF is to measure the quality of life. The WHOQOL-BREF is a self-administered questionnaire comprising 26 questions on the individual's perceptions of their health and well-being over the previous two weeks. Each item is rated on a 5-point (1-5) scale. Higher scores denote higher quality of life. |
Countries
China
Outcome results
None listed