Dementia Clinical Trial
Official title:
Effects of E-bibliotherapy on the Psychological Well-being of Informal Caregivers of People With Dementia: A Randomized Controlled Trial
Verified date | June 2023 |
Source | The Hong Kong Polytechnic University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The objective of this study is to test the efficacy of e-bibliotherapy on improving the psychological well-being of informal caregivers of people with dementia as compared with a control group.
Status | Not yet recruiting |
Enrollment | 192 |
Est. completion date | September 2026 |
Est. primary completion date | September 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - primary caregivers aged 18 or above; - provide unpaid regular care to a person with mild to moderately severe dementia (measured by Global Deterioration Scale, GDS=4~6); - have cared for the care recipient for at least six months; - assist with at least one of the care recipient's daily activities; - use a smartphone or tablet; - can read Chinese. Exclusion Criteria: - caregivers with unstable physical or mental conditions; - have cognitive impairment; - are undergoing acute treatment or have not yet stabilized on their chronic medication; - are involved in another interventional study |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
The Hong Kong Polytechnic University | Health and Medical Research Fund |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes on psychological well-being | Psychological well-being will be measured by the Chinese version of Ryff's Psychological Well-being Scale. It is a 6-point Likert scale with 1=strongly disagree to 6=totally agree. It includes 18 items. A higher score indicates better psychological well-being. | Pre-intervention, immediately post-intervention, three and six-month post-intervention | |
Secondary | Changes on caregiving appraisal | Caregiving appraisal will be measured by the Chinese version of the Caregiving Appraisal Scale. It is a 5-point Likert scale (1=extremly disagree, 5=strongly agree) including 26 items. Higher scores indicate more positive caregiving appraisal. | Pre-intervention, immediately post-intervention, three and six-month post-intervention | |
Secondary | Changes on mental health | Mental health will be measured by the Chinese version of the Depression Anxiety Stress Scale-21 (DASS-21). DASS-21 is a 4-point Likert scale (0=totally unfit my condition, 3=very fit my condition). It includes 21 items. Higher scores indicate worse mental health problems. | Pre-intervention, immediately post-intervention, three and six-month post-intervention | |
Secondary | Changes on biomarker of stress | Saliva cortisol concentration will be used. | Pre-intervention, immediately post-intervention, three and six-month post-intervention | |
Secondary | Changes on health-related quality of life | Health-related quality of life will be measured by the 12-item Short Form Survey (SF-12). SF-12 includes 12 items. Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning. | Pre-intervention, immediately post-intervention, three and six-month post-intervention |
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