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| Name | Class |
|---|---|
| Buddhist Tzu Chi General Hospital | OTHER |
| Tzu Chi University | OTHER |
| E-DA Hospital | OTHER |
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Jing Si Herbal Tea has been found to be effective in improving health for the conditions of cancers, aging, depression, and sleep. Such evidence has been shown in animal models and clinical research with publications in the international journals. However, empirical evidence regarding the effectiveness of Jing Si Herbal Tea for patients with dementia and their caregivers on their quality of life and psychosocial health remains unclear. Therefore, the present project aims to investigate the feasibility of taking Jing Si Herbal Tea among patients with dementia; then, to investigate if Jing Si Herbal Tea could improve quality of life and psychosocial health for patients with dementia and their caregivers. The project will be three years. The first year will examine the feasibility for the patients with dementia. A total of 100 patients with dementia will be recruited and they will be informed to take the Jing Si Herbal Tea two times per day (one time in the morning and another time in the afternoon). All the participants will be measured for their quality of life and psychosocial health at baseline, three months after baseline, and six months after baseline, to have initial evidence of the improvements in quality of life and psychosocial health without having a control group. The second year will recruit 200 patients with dementia and randomly assign them into a treatment group (taking Jing Si Herbal Tea) and a control group (taking placebo). All the participants will be measured for their quality of life and psychosocial health at baseline, three months after baseline, and six months after baseline, to investigate the strong evidence of Jing Si Herbal Tea on quality of life and psychosocial health. The third year will recruit 200 caregivers of patient with dementia and randomly assign them into a treatment group (taking Jing Si Herbal Tea) and a control group (taking placebo). All the participants will be measured for their quality of life and psychosocial health at baseline, three months after baseline, and six months after baseline, to investigate the strong evidence of Jing Si Herbal Tea on quality of life and psychosocial health.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Jing Si Herbal Tea Group | Experimental | Frequency: Two times of herbal tea (one in the morning; one in the afternoon) per day Duration: Consumption for three months Dosage: One pack (14g) with 600 ml water for each time of herbal tea consumption |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Jing Si Herbal Tea | Dietary Supplement | Consuming Jing Si Herbal Tea for three months; twice per day with each time 14 g of Jing Si Herbal in 600 ml water |
|
| Measure | Description | Time Frame |
|---|---|---|
| World Health Organization Quality of Life Assessment for age (WHOQOL-AGE) [for people with dementia] | quality of life measure; score range 13-65; higher score indicates better quality of life | baseline; 3 months after baseline; 6 months after baseline |
| Insomnia Severity Index [for both people with dementia and their caregivers] | sleep problem measure; score range 0-28; higher score indicates more severe insomnia | baseline; 3 months after baseline; 6 months after baseline |
| World Health Organization Quality of Life Assessment brief version (WHOQOL-BREF) [for caregivers] | quality of life measure; score range 4-20; higher score indicates better quality of life | baseline; 3 months after baseline; 6 months after baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Katz Index of Independence in Activities of Daily Living [for people with dementia] | activities of daily living function measure; score range 0-6; higher score indicates better activities of daily living | baseline; 3 months after baseline; 6 months after baseline |
| 5 items of Geriatric Depression Scale [for people with dementia and their caregivers] |
| Measure | Description | Time Frame |
|---|---|---|
| Comorbidity | Other chronic disease the participants have | baseline |
For people with dementia:
Inclusion Criteria:
Exclusion Criteria:
For caregivers:
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chung-Ying Lin, PhD | Contact | +886-2353535 | 5106 | cylin36933@gs.ncku.edu.tw |
| Name | Affiliation | Role |
|---|---|---|
| Hao-Ming Li, MD | Buddhist Tzu Chi General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tzu-Chi General Hospital | Recruiting | Hualien City | Taiwan |
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| ID | Term |
|---|---|
| D003704 | Dementia |
| D000084802 | Caregiver Burden |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D019965 | Neurocognitive Disorders |
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depression measure; score range 0-5; higher score indicates greater depression |
| baseline; 3 months after baseline; 6 months after baseline |
| Short Portable Mental Status Questionnaire [for people with dementia] | cognition measure; score range 0-10; higher score indicates poor cognition | baseline; 3 months after baseline; 6 months after baseline |
| Clinical Frailty Scale [for people with dementia] | frailty measure; score range 1-9; higher score indicates more frail | baseline; 3 months after baseline; 6 months after baseline |
| Integrated care for older people [for people with dementia] | intrinsic capacity measure; score range 0-13; higher score indicates poorer intrinsic capacity | baseline; 3 months after baseline; 6 months after baseline |
| Attitude and Thoughts Toward Older People Scale [for people with dementia and their caregivers] | ageism measure; score range 17-85; higher score indicates higher level of ageism | baseline; 3 months after baseline; 6 months after baseline |
| Depression, Anxiety, Stress Scale-21 [for people with dementia and their caregivers] | psychological distress measure; score range 0-63; higher score indicates greater distress | baseline; 3 months after baseline; 6 months after baseline |
| 12 item of Zarit Burden Interview [for caregivers] | caregiver burden measure; score range 0-48; higher score indicates greater burden | baseline; 3 months after baseline; 6 months after baseline |
| D001523 | Mental Disorders |
| D013315 | Stress, Psychological |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |