Clinical trial NCT06003647: 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
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Caregiver Burden
Keywords: Informal caregiver of person with dementia
Educational intervention
Lead sponsor: Universiti Putra Malaysia
Sponsor class: OTHER
First posted: 2023-08-22
Enrollment: 174
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: Inclusion Criteria:

1. Informal caregiver of person with dementia (children, children in law, grandchildren, grandchildren in law, spouses, siblings, parents).
2. Age 18 years old and above.
3. Able to understand, read and speak Bahasa Malaysia language

Exclusion Criteria:

1. Caregiver with previous history of mental illness.
2. Caregiver with physical disabilities that cause limitation in providing care for person with dementia.
3. Paid informal caregiver (maid).

Primary outcomes:
measure: Caregiver Burden
timeFrame: Baseline, 2 weeks after the end of educational intervention session, and 3 months after intervention
Secondary outcomes:
measure: Socio-demographic characteristic
timeFrame: Baseline
measure: Caregiving characteristics
timeFrame: Baseline
measure: Caregiver knowledge on dementia
timeFrame: Baseline, 2 weeks after the end of educational intervention session, and 3 months after intervention
measure: Caregiver self-esteem
timeFrame: Baseline, 2 weeks after the end of educational intervention session, and 3 months after intervention
measure: Caregiver mastery
timeFrame: Baseline, 2 weeks after the end of educational intervention session, and 3 months after intervention
measure: Caregiver stress coping
timeFrame: Baseline, 2 weeks after the end of educational intervention session, and 3 months after intervention
Other outcomes:
Locations:
Study officials:
affiliation: Universiti Putra Malaysia
name: Nuraisyah Hani Zulkifley
role: PRINCIPAL_INVESTIGATOR
References: