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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 451
- 试验地点
- 2
- 主要终点
- Change in Dementia Caregivers' Knowledge, Attitude, and Practice (KAP) Scores
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: DemensiaKITA mobile health application (Other)
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.
干预措施: Usual Care (Other)
结局指标
主要结局
Change in Dementia Caregivers' Knowledge, Attitude, and Practice (KAP) Scores
时间窗: Baseline, 1 month and 3 months after intervention start
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.
Change in Dementia Caregivers' Knowledge, Attitude, and Practice (KAP) Scores
时间窗: Baseline, 1 month and 3 months after intervention start
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.
次要结局
- Change in Caregiver Burden Scores(Baseline, 1 month and 3 months after intervention start)
研究者
Nurulizzah binti Mahfar
Doctor
Universiti Teknologi Mara