DemensiaKITA Mobile Health App to Improve Knowledge, Attitude, Practice and Reduce Burden Among Dementia Caregivers in Malaysia

NCT ID: NCT07212894

Last Updated: 2025-10-08

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

RECRUITING

Clinical Phase

NA

Total Enrollment

451 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-10

Study Completion Date

2026-05-31

Brief Summary

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Dementia is a growing health concern in Malaysia and places a heavy burden on family members who act as caregivers. Many caregivers struggle with limited knowledge, negative attitudes, and challenges in daily caregiving practices. These issues increase caregiver stress and reduce the quality of care for people living with dementia.

The DemensiaKITA mobile health application was developed to support caregivers by providing educational content, self-help tools, and practical guidance. This study will evaluate whether using the DemensiaKITA app can improve caregivers' knowledge, attitudes, and caregiving practices (KAP), as well as reduce caregiver burden.

This is a non-randomized controlled trial involving dementia caregivers in Kuala Lumpur and Selangor. Participants in the intervention group will use the DemensiaKITA mobile app for a set period, while the control group will continue with usual support. Outcomes will be measured before and after the intervention using validated questionnaires.

The results of this study will provide evidence on the effectiveness of a locally developed mobile health application in supporting dementia caregivers in Malaysia. If successful, this digital approach may be scaled up to improve caregiver support and dementia care in other settings.

Detailed Description

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The rising prevalence of dementia in Malaysia has increased the need for caregiver support strategies. Informal caregivers often face knowledge gaps, negative perceptions, and poor caregiving skills, collectively referred to as Knowledge, Attitude, and Practice (KAP) challenges. Additionally, caregiver burden is a well-documented consequence of long-term dementia care, leading to stress and reduced quality of life.

The DemensiaKITA mobile health application was designed to provide accessible, structured, and culturally relevant caregiver education. Its features include dementia-related knowledge modules, attitude-shaping messages to encourage empathy and positive caregiving, and practice tips for daily care. It also offers self-monitoring tools to track caregiving challenges and support caregiver well-being.

This non-randomized controlled trial will recruit dementia caregivers from Kuala Lumpur and Selangor. Participants will be allocated into intervention and control groups. The intervention group will use the DemensiaKITA app for a defined duration, while the control group will receive usual care and information. Pre- and post-intervention data will be collected using validated instruments such as the Dementia Knowledge Assessment Tool (DKAT-2), caregiver attitude and practice scales, and the Zarit Burden Interview (ZBI).

Primary outcomes include improvements in KAP scores, while secondary outcomes include reductions in caregiver burden. The study findings will inform the potential integration of mobile health applications into community-based dementia support programs in Malaysia and similar low- and middle-income country settings.

Conditions

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Dementia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

This study uses a parallel assignment model with two groups. Dementia caregivers in the intervention group will receive access to the DemensiaKITA mobile health application, which provides structured educational modules, caregiving practice tips, and self-monitoring tools. Caregivers in the control group will continue with usual care and standard support resources available in the community. Outcomes will be assessed in both groups at baseline and after the intervention period to evaluate differences in knowledge, attitude, practice, and caregiver burden.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants
This is a non-randomized, single-blinded study. Participants are blinded to their group assignment (intervention or control). Care providers and investigators are aware of the allocation, but participants are not informed which group they belong to in order to reduce bias in outcome reporting.

Study Groups

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Arm 1 (Intervention): DemensiaKITA mHealth app

Arm 1: DemensiaKITA Mobile Health App

Arm Description:

Participants in this arm will receive access to the DemensiaKITA mobile health application. The app delivers structured dementia-related education, strategies to improve caregiver knowledge, positive attitude reinforcement, and practical caregiving tips. It also provides self-monitoring features to support caregiver well-being. Participants will be encouraged to use the application regularly throughout the study period.

Group Type EXPERIMENTAL

DemensiaKITA mobile health application

Intervention Type OTHER

A mobile health application developed to support dementia caregivers. It provides structured educational modules, attitude-shaping content, and practical caregiving tips, along with self-monitoring features to reduce caregiver stress and burden. Participants in the intervention group will use the app regularly during the study period.

Arm 2 (Control): Usual care

Arm 2: Usual Care

Arm Description:

Participants in this arm will continue with their usual caregiving practices and community resources. They will not have access to the DemensiaKITA mobile health application during the study period. This group serves as the comparator to evaluate the effectiveness of the intervention.

Group Type EXPERIMENTAL

Usual Care

Intervention Type OTHER

Participants assigned to the control group will continue with usual caregiving practices and community-based resources available to dementia caregivers. They will not be given access to the DemensiaKITA mobile health application during the study period. This group provides a comparator for evaluating the added benefit of th

Interventions

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DemensiaKITA mobile health application

A mobile health application developed to support dementia caregivers. It provides structured educational modules, attitude-shaping content, and practical caregiving tips, along with self-monitoring features to reduce caregiver stress and burden. Participants in the intervention group will use the app regularly during the study period.

Intervention Type OTHER

Usual Care

Participants assigned to the control group will continue with usual caregiving practices and community-based resources available to dementia caregivers. They will not be given access to the DemensiaKITA mobile health application during the study period. This group provides a comparator for evaluating the added benefit of th

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Adults aged 18 years and above
* Primary informal caregiver of a person living with dementia (family member or household member)
* Able to read and understand Malay
* Owns a smartphone and is able to use mobile applications
* Provides informed consent to participate

Exclusion Criteria

* Professional/paid caregivers (e.g., nurses, domestic helpers hired solely for caregiving)
* Caregivers of patients with conditions other than dementia
* Individuals with severe cognitive or psychiatric illness that limits their ability to participate
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universiti Teknologi Mara

OTHER

Sponsor Role lead

Responsible Party

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Nurulizzah binti Mahfar

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nurulizzah Mahfar

Role: PRINCIPAL_INVESTIGATOR

Universiti Teknologi MARA Sg Buloh Campus

Locations

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Universiti Teknologi MARA

Sungai Buloh, Selangor, Malaysia

Site Status RECRUITING

Countries

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Malaysia

Central Contacts

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Nurulizzah Mahfar, Medical degree

Role: CONTACT

0193107344

Nik Nairan Abdullah, MBCHB BAO

Role: CONTACT

0193107344

Facility Contacts

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Nurulizzah Mahfar, MD

Role: primary

0193107344

Nik Nairan Abdullah, MBCHB BAO

Role: backup

0193107344

Other Identifiers

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UiTM-FERC/25/600-TNCPI (5/1/6)

Identifier Type: OTHER

Identifier Source: secondary_id

UiTM-DemCareKAP-2025

Identifier Type: -

Identifier Source: org_study_id

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