Effects of Jing Si Herbal Tea on Quality of Life and Sleep Among Patients With Dementia and Their Caregivers: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Insomnia Severity Index [for both people with dementia and their caregivers]
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •For people with dementia:
- •Inclusion Criteria:
- •diagnosis of dementia
- •50 years or older
- •with sufficient cognition to complete the questionnaires
- •can communicate using Mandarin or Taiwanese
排除标准
- •with renal function problems
- •not suitable for Jing Si Herbal Tea after evaluation from a psychiatrist/physician
- •with the condition of change the commencement of guardianship (or commencement of assistance)
- •For caregivers:
- •Inclusion Criteria:
- •caregivers of people with dementia for more than half years
- •20 years or older
- •with sufficient cognition to complete the questionnaires
- •can communicate using Mandarin or Taiwanese
- •Exclusion Criteria:
- •with renal function problems
- •not suitable for Jing Si Herbal Tea after evaluation from a psychiatrist/physician
- •with the condition of change the commencement of guardianship (or commencement of assistance)
研究组 & 干预措施
Jing Si Herbal Tea Group
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
干预措施: Jing Si Herbal Tea (Dietary Supplement)
结局指标
主要结局
Insomnia Severity Index [for both people with dementia and their caregivers]
时间窗: baseline; 3 months after baseline; 6 months after baseline
sleep problem measure; score range 0-28; higher score indicates more severe insomnia
World Health Organization Quality of Life Assessment for age (WHOQOL-AGE) [for people with dementia]
时间窗: baseline; 3 months after baseline; 6 months after baseline
quality of life measure; score range 13-65; higher score indicates better quality of life
World Health Organization Quality of Life Assessment brief version (WHOQOL-BREF) [for caregivers]
时间窗: baseline; 3 months after baseline; 6 months after baseline
quality of life measure; score range 4-20; higher score indicates better quality of life
次要结局
- 5 items of Geriatric Depression Scale [for people with dementia and their caregivers](baseline; 3 months after baseline; 6 months after baseline)
- Short Portable Mental Status Questionnaire [for people with dementia](baseline; 3 months after baseline; 6 months after baseline)
- Katz Index of Independence in Activities of Daily Living [for people with dementia](baseline; 3 months after baseline; 6 months after baseline)
- Clinical Frailty Scale [for people with dementia](baseline; 3 months after baseline; 6 months after baseline)
- 12 item of Zarit Burden Interview [for caregivers](baseline; 3 months after baseline; 6 months after baseline)
- Integrated care for older people [for people with dementia](baseline; 3 months after baseline; 6 months after baseline)
- Depression, Anxiety, Stress Scale-21 [for people with dementia and their caregivers](baseline; 3 months after baseline; 6 months after baseline)
- Attitude and Thoughts Toward Older People Scale [for people with dementia and their caregivers](baseline; 3 months after baseline; 6 months after baseline)
研究者
Chung-Ying Lin
Professor
National Cheng Kung University