DementiaDemensiaKITANCT07212894
DemensiaKITA Mobile Health App to Improve Knowledge, Attitude, Practice and Reduce Burden Among Dementia Caregivers in Malaysia
A study testing DemensiaKITA mobile health application in people with Dementia, run by Universiti Teknologi Mara at 1 site in Malaysia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dementia
- What is being tested?
- DemensiaKITA mobile health application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 451 participants
- Where
- 1 siteMalaysia
- Study dates
- 10 Oct 2025to 31 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Malaysia1 site, 1 recruiting
- Recruiting
Universiti Teknologi MARA
Sungai Buloh, Selangor, 47000
Nurulizzah Mahfar, MD, 0193107344, izzahmahfar@gmail.com
Nik Nairan Abdullah, MBCHB BAO, 0193107344, niknairan@gmail.com
About this study
Official title: 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
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.
Read more
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.
Read the detailed description
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
- Dementia
- Being tested
- DemensiaKITA mobile health application, Usual Care
- Keywords
- Dementia, Informal Caregivers, Mobile health application, Knowledge Attitude Practice, Burden level, Malaysia
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DemensiaKITA mobile health applicationOther
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.
Usual CareOther
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
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 (Intervention): DemensiaKITA mHealth app | Experimental | 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. Receives: Other: DemensiaKITA mobile health application |
| Arm 2 (Control): Usual care | Experimental | 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. Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 1 month and 3 months after intervention start
Secondary outcomes (1)
Change in Caregiver Burden Scores
Caregiver burden will be measured using the Zarit Burden Interview (ZBI), a validated questionnaire assessing the level of stress, emotional strain, and impact of caregiving responsibilities. The outcome is the change in ZBI scores between baseline and post-intervention. Lower scores indicate reduced caregiver burden.
Measured: Baseline, 1 month and 3 months after intervention start
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2025
- Study start10 Oct 2025 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 451 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universiti Teknologi Mara
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nurulizzah binti Mahfar, Universiti Teknologi Mara
- Investigators
- Nurulizzah Mahfar, Principal investigator, Universiti Teknologi MARA Sg Buloh Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07212894
- Sponsor's protocol ID
- UiTM-DemCareKAP-2025
- Other IDs
- UiTM-FERC/25/600-TNCPI (5/1/6)
- Acronym
- DemensiaKITA
- Status last verified
- Sep 2025
- First submitted
- 1 Oct 2025
- Last updated
- 8 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07212894
- Acronym / sponsor ID
- DemensiaKITA / UiTM-DemCareKAP-2025
- Conditions
- Dementia
- Keywords
- Dementia, Informal Caregivers, Mobile health application, Knowledge Attitude Practice, Burden level, Malaysia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 451 participants (estimated)
- Lead sponsor
- Universiti Teknologi MaraUniversity, hospital or other
- Study start
- 10 Oct 2025 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 May 2026 (estimated)
- First posted
- 8 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Arm 1 (Intervention): DemensiaKITA mHealth app | Experimental | Other: DemensiaKITA mobile health applicationArm 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 | Experimental | Other: Usual CareArm 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DemensiaKITA mobile health applicationA 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. | Other | Arm 1 (Intervention): DemensiaKITA mHealth app |
| Usual CareParticipants 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 | Other | Arm 2 (Control): Usual care |
Primary outcome
Change in Dementia Caregivers' Knowledge, Attitude, and Practice (KAP) Scores
Time frame: 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.
1 secondary outcome
Change in Caregiver Burden Scores
Time frame: Baseline, 1 month and 3 months after intervention start
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2025.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nurulizzah Mahfar principal investigator
Universiti Teknologi MARA Sg Buloh Campus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DemensiaKITA mobile health application in people with Dementia, run by Universiti Teknologi Mara at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nurulizzah Mahfar, Medical degree (0193107344, izzahmahfar@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Dementia Caregivers' Knowledge, Attitude, and Practice (KAP) Scores (time frame: Baseline, 1 month and 3 months after intervention start). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2025.