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Educational Intervention Among Informal Caregivers of Person With Dementia

Primary Purpose

Caregiver Burden

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Educational Intervention
Sponsored by
Universiti Putra Malaysia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Caregiver Burden focused on measuring Informal caregiver of person with dementia, Educational intervention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Informal caregiver of person with dementia (children, children in law, grandchildren, grandchildren in law, spouses, siblings, parents). Age 18 years old and above. Able to understand, read and speak Bahasa Malaysia language Exclusion Criteria: Caregiver with previous history of mental illness. Caregiver with physical disabilities that cause limitation in providing care for person with dementia. Paid informal caregiver (maid).

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    Control

    Intervention

    Arm Description

    Receive normal care

    Educational intervention

    Outcomes

    Primary Outcome Measures

    Caregiver Burden
    The caregiver burden measured by using Zarit Burden Interview (ZBI). ZBI consisted of 22 items with all negative statements. The scoring will be zero for never, one for rarely, two for sometimes, three for quite frequently and four for nearly always. The scoring can be from zero to 88 with scoring of 0 to 21 little or no burden, 21 to 40 mild to moderate burden, 41 to 60 moderates to severe burden, and 61 to 88 severe burdens.

    Secondary Outcome Measures

    Socio-demographic characteristic
    To describe the characteristics (age, gender, ethnic, level of education, employment status, relationship with demented person, monthly household income) of the caregiver of person with dementia
    Caregiving characteristics
    To describe the caregiving characteristics (time spent with dementia person, severity of dementia person, functional abilities of dementia person, supports group availability) of the caregiver of person with dementia
    Caregiver knowledge on dementia
    Caregiver knowledge on dementia will be based on the dementia knowledge assessment scale (DKAS) which use to explore what different individuals understand about dementia by using a multi-domain measure of dementia knowledge. The scale use five answer of measurement which is false, probably false, probably true, true and I do not know. Two points of score would be given for an answer of true to a true statement and false to a false statement. One point of score would be given for an answer of probably true to a true statement and probably false to a false statement. If the respondents give an answer of true on a false statement, false on a true statement and any answer of I do not know would be given zero point. The maximum score for the DKAS is 50 points and the respondent can be categorized on having a good knowledge if they score 40 and above, moderate level of knowledge if the score 25 to 39, and poor level of knowledge if they score below than 25 points.
    Caregiver self-esteem
    The caregiver self-esteem will be measure by using the short sense of competence questionnaire. The scale is used to measure three domains which are the caregiver consequences of involvement in care for caregiver personal life, satisfaction with one's own performance as a caregiver and satisfaction with the demented person as a recipient care. The scoring for the scale would be one for strongly agree, two for agree, three for neutral, four for disagree and five for strongly disagree for the negative statement items. The scoring will be vice versa for the positive statement item. Higher scores indicate greater levels of competence.
    Caregiver mastery
    The caregiver mastery is measured by using the Pearlin Mastery Scale by Pearlin and Schooler which used to explore protective buffer for caregiver' mental and physical health and well-being, when facing persistent life stresses, such as economic and occupational hardships.The scale used four-point Likert scale with one for strongly disagree, two for disagree, three for agree, and four for strongly agree. Items are summed, yielding a range from 7 to 28. Higher scores indicate greater levels of mastery.
    Caregiver stress coping
    The caregiver stress coping will be measure by using The Coping Strategy Indicator (CSI) that is used to measures coping responses to a specific stressful event. Respondents who have high scored in the problem-solving scale were not likely to seek distraction or support. High score in the social support and avoidance scale indicates that, caregivers are not likely sought for information or distraction. High score in the avoidance subscale also most commonly predictive of negative mental health outcome such as depression and anxiety.

    Full Information

    First Posted
    August 7, 2023
    Last Updated
    August 23, 2023
    Sponsor
    Universiti Putra Malaysia
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06003647
    Brief Title
    Educational Intervention Among Informal Caregivers of Person With Dementia
    Official Title
    Educational Intervention Among Informal Caregivers of Person With Dementia in Klang Valley, Malaysia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 1, 2023 (Anticipated)
    Primary Completion Date
    December 31, 2023 (Anticipated)
    Study Completion Date
    March 1, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Universiti Putra Malaysia

    4. Oversight

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

    5. Study Description

    Brief Summary
    The goal of this intervention study is to test whether the educational intervention work well or not on informal caregiver of person with dementia. The main question it aims to answer is does the educational intervention will help to reduce the caregiver burden experience by the informal caregiver. Participants will be given an educational module and short videos that they can refer to gain more knowledge and skills in caring for the person with dementia.
    Detailed Description
    Caregivers for this study will be recruited at the geriatric, neurology and, psychiatry outpatient clinic. The caregiver will be approached by the primary researcher and explained about the details of the study. The caregivers will be given the participant information sheet and if they agree to participate in the study, written informed consent will be obtained. The researcher will then check the eligibility of the caregiver to participate. If the caregiver was eligible to participate, they will be ask to provide contact details for researcher to assign tentative date for the virtual educational session. The caregiver will be then randomly assigned to control or intervention group before the baseline data were collected. This study will use equal allocation with a ratio of one to one for each two groups. The caregiver will be randomly allocated by using permuted block randomization technique. This study will be conducted as single blind study. Only the respondents would be blinded and concealed from the group allocation. The intervention group will be given the educational intervention which are educational module and short videos related to dementia care. After the baseline data collection, the soft copy of the educational module will be shared to the participants via WhatsApp messenger so that they can review the module before the virtual educational session. One short educational video will be then shared to all the participants through individual WhatsApp in each Wednesday of the week for 12 weeks. Each of the short video will contain subtopics of the educational module and each video will be around two to three minutes. After the video shared to the participants, they are encouraged to ask any questions related to the content of the video.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Caregiver Burden
    Keywords
    Informal caregiver of person with dementia, Educational intervention

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    174 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    Receive normal care
    Arm Title
    Intervention
    Arm Type
    Experimental
    Arm Description
    Educational intervention
    Intervention Type
    Other
    Intervention Name(s)
    Educational Intervention
    Intervention Description
    Educational module and video
    Primary Outcome Measure Information:
    Title
    Caregiver Burden
    Description
    The caregiver burden measured by using Zarit Burden Interview (ZBI). ZBI consisted of 22 items with all negative statements. The scoring will be zero for never, one for rarely, two for sometimes, three for quite frequently and four for nearly always. The scoring can be from zero to 88 with scoring of 0 to 21 little or no burden, 21 to 40 mild to moderate burden, 41 to 60 moderates to severe burden, and 61 to 88 severe burdens.
    Time Frame
    Baseline, 2 weeks after the end of educational intervention session, and 3 months after intervention
    Secondary Outcome Measure Information:
    Title
    Socio-demographic characteristic
    Description
    To describe the characteristics (age, gender, ethnic, level of education, employment status, relationship with demented person, monthly household income) of the caregiver of person with dementia
    Time Frame
    Baseline
    Title
    Caregiving characteristics
    Description
    To describe the caregiving characteristics (time spent with dementia person, severity of dementia person, functional abilities of dementia person, supports group availability) of the caregiver of person with dementia
    Time Frame
    Baseline
    Title
    Caregiver knowledge on dementia
    Description
    Caregiver knowledge on dementia will be based on the dementia knowledge assessment scale (DKAS) which use to explore what different individuals understand about dementia by using a multi-domain measure of dementia knowledge. The scale use five answer of measurement which is false, probably false, probably true, true and I do not know. Two points of score would be given for an answer of true to a true statement and false to a false statement. One point of score would be given for an answer of probably true to a true statement and probably false to a false statement. If the respondents give an answer of true on a false statement, false on a true statement and any answer of I do not know would be given zero point. The maximum score for the DKAS is 50 points and the respondent can be categorized on having a good knowledge if they score 40 and above, moderate level of knowledge if the score 25 to 39, and poor level of knowledge if they score below than 25 points.
    Time Frame
    Baseline, 2 weeks after the end of educational intervention session, and 3 months after intervention
    Title
    Caregiver self-esteem
    Description
    The caregiver self-esteem will be measure by using the short sense of competence questionnaire. The scale is used to measure three domains which are the caregiver consequences of involvement in care for caregiver personal life, satisfaction with one's own performance as a caregiver and satisfaction with the demented person as a recipient care. The scoring for the scale would be one for strongly agree, two for agree, three for neutral, four for disagree and five for strongly disagree for the negative statement items. The scoring will be vice versa for the positive statement item. Higher scores indicate greater levels of competence.
    Time Frame
    Baseline, 2 weeks after the end of educational intervention session, and 3 months after intervention
    Title
    Caregiver mastery
    Description
    The caregiver mastery is measured by using the Pearlin Mastery Scale by Pearlin and Schooler which used to explore protective buffer for caregiver' mental and physical health and well-being, when facing persistent life stresses, such as economic and occupational hardships.The scale used four-point Likert scale with one for strongly disagree, two for disagree, three for agree, and four for strongly agree. Items are summed, yielding a range from 7 to 28. Higher scores indicate greater levels of mastery.
    Time Frame
    Baseline, 2 weeks after the end of educational intervention session, and 3 months after intervention
    Title
    Caregiver stress coping
    Description
    The caregiver stress coping will be measure by using The Coping Strategy Indicator (CSI) that is used to measures coping responses to a specific stressful event. Respondents who have high scored in the problem-solving scale were not likely to seek distraction or support. High score in the social support and avoidance scale indicates that, caregivers are not likely sought for information or distraction. High score in the avoidance subscale also most commonly predictive of negative mental health outcome such as depression and anxiety.
    Time Frame
    Baseline, 2 weeks after the end of educational intervention session, and 3 months after intervention

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Informal caregiver of person with dementia (children, children in law, grandchildren, grandchildren in law, spouses, siblings, parents). Age 18 years old and above. Able to understand, read and speak Bahasa Malaysia language Exclusion Criteria: Caregiver with previous history of mental illness. Caregiver with physical disabilities that cause limitation in providing care for person with dementia. Paid informal caregiver (maid).
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ms
    Phone
    +60195249479
    Email
    hanizulkifley@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Nuraisyah Hani Zulkifley
    Organizational Affiliation
    Universiti Putra Malaysia
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Educational Intervention Among Informal Caregivers of Person With Dementia

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