Clinical trial NCT06198699: Effects of Jing Si Herbal Tea on Quality of Life and Sleep in Dementia and Their Caregivers
Official title: Effects of Jing Si Herbal Tea on Quality of Life and Sleep Among Patients With Dementia and Their Caregivers: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Dementia
Caregiver Burden
Quality of Life
Keywords: dementia
caregiver
quality of life
Jing Si Herbal Tea
psychosocial health
randomized controlled trial
Lead sponsor: National Cheng Kung University
Sponsor class: OTHER
Collaborators: name: Buddhist Tzu Chi General Hospital
name: Tzu Chi University
name: E-DA Hospital
First posted: 2024-01-10
Enrollment: 400
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

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)

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)

Primary outcomes:
measure: World Health Organization Quality of Life Assessment for age (WHOQOL-AGE) [for people with dementia]
timeFrame: baseline; 3 months after baseline; 6 months after baseline
measure: Insomnia Severity Index [for both people with dementia and their caregivers]
timeFrame: baseline; 3 months after baseline; 6 months after baseline
measure: World Health Organization Quality of Life Assessment brief version (WHOQOL-BREF) [for caregivers]
timeFrame: baseline; 3 months after baseline; 6 months after baseline
Secondary outcomes:
measure: Katz Index of Independence in Activities of Daily Living [for people with dementia]
timeFrame: baseline; 3 months after baseline; 6 months after baseline
measure: 5 items of Geriatric Depression Scale [for people with dementia and their caregivers]
timeFrame: baseline; 3 months after baseline; 6 months after baseline
measure: Short Portable Mental Status Questionnaire [for people with dementia]
timeFrame: baseline; 3 months after baseline; 6 months after baseline
measure: Clinical Frailty Scale [for people with dementia]
timeFrame: baseline; 3 months after baseline; 6 months after baseline
measure: Integrated care for older people [for people with dementia]
timeFrame: baseline; 3 months after baseline; 6 months after baseline
measure: Attitude and Thoughts Toward Older People Scale [for people with dementia and their caregivers]
timeFrame: baseline; 3 months after baseline; 6 months after baseline
measure: Depression, Anxiety, Stress Scale-21 [for people with dementia and their caregivers]
timeFrame: baseline; 3 months after baseline; 6 months after baseline
measure: 12 item of Zarit Burden Interview [for caregivers]
timeFrame: baseline; 3 months after baseline; 6 months after baseline
Other outcomes:
measure: Comorbidity
timeFrame: baseline
Locations:
Study officials:
References: