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E-bibliotherapy for Informal Caregivers of People With Dementia

Primary Purpose

Dementia, Caregiver Stress Syndrome, Psychological Well-Being

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
E-bibliotherapy
Control
Sponsored by
The Hong Kong Polytechnic University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Dementia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Sham Comparator

    Arm Label

    Intervention group

    Control group

    Arm Description

    Eight weekly sessions of e-bibliotherapy. Participants in the intervention group will use the e-bibliotherapy app we develop, and accept e-bibliotherapy via the app.

    Eight weekly sessions of self-learning of general daily living knowledge that this different from the intervention contents from the same e-bibliotherapy app.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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.
    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.
    Changes on biomarker of stress
    Saliva cortisol concentration will be used.
    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.

    Full Information

    First Posted
    June 16, 2023
    Last Updated
    June 25, 2023
    Sponsor
    The Hong Kong Polytechnic University
    Collaborators
    Health and Medical Research Fund
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05927805
    Brief Title
    E-bibliotherapy for Informal Caregivers of People With Dementia
    Official Title
    Effects of E-bibliotherapy on the Psychological Well-being of Informal Caregivers of People With Dementia: A Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 2023 (Anticipated)
    Primary Completion Date
    September 2026 (Anticipated)
    Study Completion Date
    September 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    The Hong Kong Polytechnic University
    Collaborators
    Health and Medical Research Fund

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    This project is a two-arm randomized controlled trial evaluating the effects of e-bibliotherapy on improving the psychological well-being of informal caregivers of people with dementia. One hundred and ninety-two informal caregivers of people with dementia will be recruited. Participants in the intervention group will receive eight weekly e-bibliotherapy sessions. The control group will get access to the same e-bibliotherapy app but accept only general daily living knowledge. Psychological well-being, caregiving appraisal, mental health, biomarker of stress, and health-related quality of life will be measured to test the effects of e-bibliotherapy immediately post-intervention, three months post-intervention, and six months post-intervention. Focus group interviews will be conducted immediately post-intervention to explore caregivers' experiences participating in this study.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Dementia, Caregiver Stress Syndrome, Psychological Well-Being

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    192 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention group
    Arm Type
    Experimental
    Arm Description
    Eight weekly sessions of e-bibliotherapy. Participants in the intervention group will use the e-bibliotherapy app we develop, and accept e-bibliotherapy via the app.
    Arm Title
    Control group
    Arm Type
    Sham Comparator
    Arm Description
    Eight weekly sessions of self-learning of general daily living knowledge that this different from the intervention contents from the same e-bibliotherapy app.
    Intervention Type
    Other
    Intervention Name(s)
    E-bibliotherapy
    Intervention Description
    Participants in the intervention group will accept eight weekly sessions of e-bibliotherapy. The e-bibliotherapy will be delivered via the e-bibliotherapy app we develop and includes eight e-bibliotherapy sessions, each focusing on one active component that may affect a caregiver's mental well-being.
    Intervention Type
    Other
    Intervention Name(s)
    Control
    Intervention Description
    The control group will give access to the same e-bibliotherapy app, but only be authorized to access general daily living knowledge that is different from the intervention contents. They will also be asked to finish a session each week for eight weeks.
    Primary Outcome Measure Information:
    Title
    Changes on psychological well-being
    Description
    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.
    Time Frame
    Pre-intervention, immediately post-intervention, three and six-month post-intervention
    Secondary Outcome Measure Information:
    Title
    Changes on caregiving appraisal
    Description
    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.
    Time Frame
    Pre-intervention, immediately post-intervention, three and six-month post-intervention
    Title
    Changes on mental health
    Description
    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.
    Time Frame
    Pre-intervention, immediately post-intervention, three and six-month post-intervention
    Title
    Changes on biomarker of stress
    Description
    Saliva cortisol concentration will be used.
    Time Frame
    Pre-intervention, immediately post-intervention, three and six-month post-intervention
    Title
    Changes on health-related quality of life
    Description
    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.
    Time Frame
    Pre-intervention, immediately post-intervention, three and six-month post-intervention

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

    E-bibliotherapy for Informal Caregivers of People With Dementia

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