Effects of Jing Si Herbal Tea on Quality of Life and Sleep in Dementia and Their Caregivers

Официальное название

Effects of Jing Si Herbal Tea on Quality of Life and Sleep Among Patients With Dementia and Their Caregivers: A Randomized Controlled Trial

Обзор

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.

Вмешательства

• Пищевая добавка Jing Si Herbal Tea
  Consuming Jing Si Herbal Tea for three months; twice per day with each time 14 g of Jing Si Herbal in 600 ml water

Первичные конечные точки

• World Health Organization Quality of Life Assessment for age (WHOQOL-AGE) [for people with dementia] [Срок оценки: baseline; 3 months after baseline; 6 months after baseline]
• Insomnia Severity Index [for both people with dementia and their caregivers] [Срок оценки: baseline; 3 months after baseline; 6 months after baseline]
• World Health Organization Quality of Life Assessment brief version (WHOQOL-BREF) [for caregivers] [Срок оценки: baseline; 3 months after baseline; 6 months after baseline]

Вторичные конечные точки (8)

• Katz Index of Independence in Activities of Daily Living [for people with dementia] [Срок оценки: baseline; 3 months after baseline; 6 months after baseline]
• 5 items of Geriatric Depression Scale [for people with dementia and their caregivers] [Срок оценки: baseline; 3 months after baseline; 6 months after baseline]
• Short Portable Mental Status Questionnaire [for people with dementia] [Срок оценки: baseline; 3 months after baseline; 6 months after baseline]
• Clinical Frailty Scale [for people with dementia] [Срок оценки: baseline; 3 months after baseline; 6 months after baseline]
• Integrated care for older people [for people with dementia] [Срок оценки: baseline; 3 months after baseline; 6 months after baseline]
• Attitude and Thoughts Toward Older People Scale [for people with dementia and their caregivers] [Срок оценки: baseline; 3 months after baseline; 6 months after baseline]
• Depression, Anxiety, Stress Scale-21 [for people with dementia and their caregivers] [Срок оценки: baseline; 3 months after baseline; 6 months after baseline]
• 12 item of Zarit Burden Interview [for caregivers] [Срок оценки: baseline; 3 months after baseline; 6 months after baseline]

Критерии участия

For people with dementia:

Критерии включения

• diagnosis of dementia
• 50 years or older
• with sufficient cognition to complete the questionnaires
• can communicate using Mandarin or Taiwanese

Критерии исключения

• 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:

Критерии включения

• 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

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Тайвань · 1 центр

• Tzu-Chi General Hospital — Hualien City

Идентификаторы

NCT: NCT06198699 · TCMF-JCT 113-03

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗