The Effect of the DemensiaKITA Mobile Health App Intervention on Knowledge, Attitude, Practice, and Burden Level of Dementia Caregivers in Kuala Lumpur and Selangor, Malaysia: Protocol for a Nonrandomized Controlled Trial

Background: Dementia is a growing public health concern, disproportionately affecting low- and middle-income countries. Caregivers of people living with dementia often face significant physical, psychological, social, and financial burdens, with high prevalence rates of caregiver strain in Malaysia. Mobile health (mHealth) apps have demonstrated potential to enhance caregivers' knowledge, attitudes, and practices (KAP) and to reduce burden. However, few culturally tailored solutions exist for Malaysia. The DemensiaKITA app was developed to provide locally relevant information, support services, and stress management tools for dementia caregivers. Objective: The purpose of this single-blinded, nonrandomized controlled trial (NRCT) is to evaluate the effectiveness of the DemensiaKITA mHealth app in improving caregivers' KAP and reducing caregiver burden in Selangor and Kuala Lumpur, Malaysia. Methods: This research will be conducted in 2 phases. Phase 1 involves the adaptation, translation, and validation of 4 instruments: Dementia Knowledge Assessment Tool Version 2, Dementia Attitudes Scale, Caregiver Task Inventory-25 items, and Short-form Zarit Burden Interview-12 items. Content, face, and construct validity, along with reliability (Cronbach α and test-retest intraclass correlation), will be established. Phase 2 is a single-blinded NRCT conducted in 4 public hospitals. A total of 100 caregivers will be recruited. Two intervention hospitals will receive the DemensiaKITA app, while 2 control hospitals will receive usual care (Ministry of Health dementia leaflets and video). The primary outcomes (KAP) and secondary outcome (burden level) will be assessed at baseline, 1 month, and 3 months using the validated questionnaires on an intention-to-treat basis. Data will be analyzed with descriptive statistics, chi-square and t tests, and generalized estimating equations. Results: Recruitment and baseline data collection are underway. Recruitment for Phase 1 (instrument validation) occurred from December 2024 until July 2025. It is expected to produce valid and reliable Malay versions of KAP and burden instruments. Recruitment for the Phase 2 NRCT will occur from August 2025 until February 2026. The first follow-up data collection for Phase 2 will occur 1 month after baseline, and the second and final follow-up will occur at 3 months. Data analysis has not yet begun. Phase 2 is expected to show significant improvements in dementia KAP and reduced caregiver burden in the intervention group compared to controls. This study was conducted without any specific external financial support or grants from any public, commercial, or not-for-profit funding agencies. The study findings are expected to be published in December 2026. Conclusions: This article describes the protocol for a single-blinded NRCT examining a novel mHealth intervention. The DemensiaKITA app has the potential to empower caregivers, enhance dementia care practices, and alleviate caregiver burden in Malaysia and may serve as a model for other low- and middle-income countries globally.