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Educational Intervention Among Informal Caregivers of Person With Dementia

NCT ID: NCT06003647

Last Updated: 2023-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

174 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-15

Study Completion Date

2024-09-01

Brief Summary

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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

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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.

Conditions

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Caregiver Burden

Keywords

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Informal caregiver of person with dementia Educational intervention

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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Control

Receive normal care

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention

Educational intervention

Group Type EXPERIMENTAL

Educational Intervention

Intervention Type OTHER

Educational module and video

Interventions

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Educational Intervention

Educational module and video

Intervention Type OTHER

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universiti Putra Malaysia

OTHER

Sponsor Role lead

Responsible Party

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Nuraisyah Hani Binti Zulkifley

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nuraisyah Hani Zulkifley

Role: PRINCIPAL_INVESTIGATOR

Universiti Putra Malaysia

Central Contacts

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Ms

Role: CONTACT

Phone: +60195249479

Email: [email protected]

Other Identifiers

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NMRR-19-3298-50711

Identifier Type: -

Identifier Source: org_study_id