DemensiaKITA Mobile Health App to Improve Knowledge, Attitude, Practice and Reduce Burden Among Dementia Caregivers in Malaysia
DemensiaKITA
The Effect of DemensiaKITA Mobile Health Application Intervention on Knowledge, Attitude, Practice (KAP) and Burden Level of Dementia Caregivers in Kuala Lumpur and Selangor, Malaysia: Protocol for a Non-Randomized Controlled Trial
2 other identifiers
interventional
451
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2025
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 1, 2025
CompletedFirst Posted
Study publicly available on registry
October 8, 2025
CompletedStudy Start
First participant enrolled
October 10, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2026
ExpectedOctober 8, 2025
September 1, 2025
3 months
October 1, 2025
October 1, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Dementia Caregivers' Knowledge, Attitude, and Practice (KAP) Scores
Caregiver knowledge, attitude, and practice will be assessed using validated instruments, including the Dementia Knowledge Assessment Tool (DKAT-2) and caregiver attitude and practice scales. The primary outcome is the change in KAP scores between baseline and post-intervention, comparing the intervention (DemensiaKITA app) and control (usual care) groups. Higher scores indicate better knowledge, more positive attitudes, and improved caregiving practices.
Baseline, 1 month and 3 months after intervention start
Secondary Outcomes (1)
Change in Caregiver Burden Scores
Baseline, 1 month and 3 months after intervention start
Study Arms (2)
Arm 1 (Intervention): DemensiaKITA mHealth app
EXPERIMENTALArm 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.
Arm 2 (Control): Usual care
EXPERIMENTALArm 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.
Interventions
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.
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Universiti Teknologi MARA
Sungai Buloh, Selangor, 47000, Malaysia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nurulizzah Mahfar
Universiti Teknologi MARA Sg Buloh Campus
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- 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.
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Doctor
Study Record Dates
First Submitted
October 1, 2025
First Posted
October 8, 2025
Study Start
October 10, 2025
Primary Completion
December 31, 2025
Study Completion (Estimated)
May 31, 2026
Last Updated
October 8, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share
The study will not share individual participant data (IPD) due to ethical considerations and data protection regulations in Malaysia. The data involve informal caregivers of persons living with dementia, a population considered vulnerable. Sharing de-identified datasets may still pose a risk of re-identification, especially given the relatively small sample size and localized recruitment sites. Instead, study findings will be disseminated through peer-reviewed publications, conference presentations, and summary results reported on ClinicalTrials.gov, ensuring transparency while protecting participant confidentiality.