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Caregiver BurdenNCT05551533

Mobile App Intervention for Informal Dementia Caregivers

A study testing Kampung Care App in people with Caregiver Burden and Dementia, run by Institute of Mental Health, Singapore at 1 site in Singapore.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Informal caregivers of persons with dementia (PWD) usually experience elevated levels of caregiving burden and potential depression. This project aims to develop and pilot-test a mobile app intervention for informal caregivers of PWD in Singapore. Read more about this study

Who is it for?
Ages 21 years and olderHealthy volunteers can take part
Conditions the study is for
Caregiver Burden, Dementia, Digital Health
What is being tested?
Kampung Care App
Could I receive a placebo?
No, everyone receives an active treatment
How many people
59 participants
Where
1 siteSingapore
Study dates
1 Dec 2022to 1 Jun 2024
Phase
Interventional
Are there results?
None posted in the registry

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 21 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • aged 21 or above;
  • Singapore citizen or permanent resident;
  • primary caregiver who is currently taking care of a PWD;
  • scores 4 and above using the 4-item screening version Zarit Burden Interview;
  • has sufficient skills in using mobile apps;
  • able to read, write, and speak in English

Who cannot join

  • Caregivers who are pregnant
  • caregivers with vision and hearing problems

Trial locations and contacts

1 site in 1 country.

Singapore1 site
  • Clinic B, Institute of Mental Health

    Singapore, Singapore, 539747

Other trials in Singapore

About this study

Official title: Design and Pilot-test of an Innovative Mobile-based Intervention to Promote Mental Health of Informal Dementia Caregivers Through User-Centered Design

Informal caregivers of persons with dementia (PWD) usually experience elevated levels of caregiving burden and potential depression. This project aims to develop and pilot-test a mobile app intervention for informal caregivers of PWD in Singapore. The project will have three phases in total including 1) phase 1 - to develop the app prototype and collect feedback from caregivers via focused group discussions. 2) a pilot RCT with 60 participants in total - 30 will be required to use the app for one month while another 30 will be on a waiting list for one month. and 3) in-depth interviews to seek users' feedback on the app for its future improvements. We hypothesize that the mobile app designed through a user-centered process would lead to high acceptance and high user engagement among local dementia caregivers. The 1-month intervention using the app developed subsequently would lower the reported depressive symptoms among local dementia caregiver. It will also improve their knowledge of dementia, caregiving efficacy, positive coping strategy, perceived positive aspects of caregiver and social support, and their mental well-being; and reduce their caregiving burden, and level of anxiety, compared to the control group.

Read the detailed description

The prevalence of dementia was found to be 10% among residents aged 60 years and above in Singapore according to the Well-being of the Singapore Elderly study, equivalent to 51,934 older adults. As the population is aging in Singapore, and the fact that the incidence of dementia doubles with every 6.3-year increase in age after 60 years old, this number is going to grow as well, together with an increasing number of their informal caregivers. Informal caregivers of persons with dementia (PWD) usually experience elevated levels of caregiving burden from supporting the daily functioning of the PWD as well as issues such as work-family-caregiving conflicts and social isolation. These stressors can lead to potential depression among informal caregivers. The aggregate prevalence of depression was reported to be 34% according to a previous meta-analysis. Due to their heavy involvement in daily caregiving, caregivers usually have difficulties in attending face-to-face interventions. For instance, the average weekly hours spent on caregiving were reported to be 55 hours in our recent study among local informal caregivers. And this situation might be even worse in the current COVID-19 outbreak. To better support them now and in the future, an alternative could be to rely on a mobile-based intervention, as the penetration rate of smartphones among local residents is quite high (aged 15-49: >95%, aged 50-59: 88%, and aged 60 and above: 56%). Several studies have strengthened the evidence that these methods are feasible and acceptable among dementia caregivers. And preliminary evidence also suggested that such interventions were viable and potentially effective in promoting the mental health status among informal dementia caregivers.

This study aims to address the following gaps - Firstly, there is a lack of user-centered design in app development as well as rigorously designed studies based on a clear theoretical framework for dementia caregivers. Secondly, none of the existing evidence-based mobile apps for supporting dementia caregivers is Singapore-based. Lastly, a mobile-based intervention developed with culturally relevant knowledge, support, and resources is needed for local dementia caregivers, especially seeing the current Covid-19 outbreak and the new normal in the future.

Primary Objective The current study aims to design and develop a mobile-based multi-component intervention (i.e. an app) to promote mental health among informal caregivers of individuals with dementia in Singapore, and pilot-test the effectiveness of the app among a convenience sample of local informal dementia caregivers.

Secondary Objective(s) Secondary objectives include 1) seeking users' feedback and identifying areas for future improvements; 2) exploring the potential for future bigger trials; 3) providing a development framework for future similar programs.

Being tested
Kampung Care App
Medical subject headings
Caregiver Burden, Dementia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Kampung Care AppOther

    Please refer to the previous session

Study groups in NCT05551533
Study groupRoleWhat they receive
InterventionExperimentalTo use the mobile app developed by the study team for one month. The app has a few key features including a positive reflection journal, online peer support, knowledge sharing, self-assessment, and locally available resources. Participants in the intervention group will be required to complete at least two positive reflection journal entries per week, and will be encouraged to use other features of the app during the one month period.
Receives: Other: Kampung Care App
Wait listNo interventionParticipants in this group will be put on a wait-list for one month before they can use the app.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Baseline depressive symptom

    Centre for Epidemiological Study Scale (0-60), with a higher score indicating a more severe depressive symptom

    Measured: baseline - before the intervention

  2. Post-intervention depressive symptom

    Centre for Epidemiological Study Scale (0-60), with a higher score indicating a more severe depressive symptom

    Measured: within 2 weeks after the intervention

Secondary outcomes (14)
  1. Baseline knowledge of dementia

    Dementia Knowledge Assessment Scale (0-54), with higher score indicating better knowledge on dementia

    Measured: baseline - before the intervention

  2. Post intervention knowledge of dementia

    Dementia Knowledge Assessment Scale (0-54), with higher score indicating better knowledge on dementia

    Measured: within 2 weeks after the intervention

  3. Baseline caregiving self-efficacy

    Revised Scale for Caregiving Self-efficacy (0-100), with higher score indicating more confidence in caregiving

    Measured: baseline - before the intervention

  4. Post intervention caregiving self-efficacy

    Revised Scale for Caregiving Self-efficacy (0-100), with higher score indicating more confidence in caregiving

    Measured: within 2 weeks after the intervention

  5. Baseline coping strategy

    brief Coping Orientation to Problems Experienced inventory - it has a total of 14 subscales, for each subscale higher score indicating more frequent usage of that specific coping strategy

    Measured: baseline - before the intervention

  6. Post intervention coping strategy

    brief Coping Orientation to Problems Experienced inventory - it has a total of 14 subscales, for each subscale higher score indicating more frequent usage of that specific coping strategy

    Measured: within 2 weeks after the intervention

  7. Baseline positive aspects of caregiving

    Positive Aspects of Caregiving Scale (9-45) - with a higher score indicates a more positive caregiving experience

    Measured: baseline - before the intervention

  8. Post intervention positive aspects of caregiving

    Positive Aspects of Caregiving Scale (9-45) - with a higher score indicates a more positive caregiving experience

    Measured: within 2 weeks after the intervention

  9. Baseline caregiver burden

    Zarit burden interview (0-88) - with a higher score indicating higher perceived caregiving burden

    Measured: baseline - before the intervention

  10. Post intervention caregiver burden

    Zarit burden interview (0-88) - with a higher score indicating higher perceived caregiving burden

    Measured: within 2 weeks after the intervention

  11. Baseline anxiety level

    Generalized Anxiety Disorder 7-item scale (0-21) - with a higher score indicating higher anxiety level

    Measured: baseline - before the intervention

  12. Post intervention anxiety level

    Generalized Anxiety Disorder 7-item scale (0-21) - with a higher score indicating higher anxiety level

    Measured: within 2 weeks after the intervention

  13. Baseline mental well-being

    Short Positive Mental Health instrument (1-6) - with a higher score indicating higher positive mental health

    Measured: baseline - before the intervention

  14. Post intervention mental well-being

    Short Positive Mental Health instrument (1-6) - with a higher score indicating higher positive mental health

    Measured: within 2 weeks after the intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Sep 2022
  2. Study start1 Dec 2022
  3. Primary completion1 Mar 2024
  4. Study completion1 Jun 2024

Resources

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
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
59 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05551533
Sponsor's protocol ID
PHG20.P.I.2.6
Status last verified
Jan 2026
First submitted
16 Sep 2022
Last updated
7 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Our IRB requires a signed research collaboration agreement before we can share the data. Parties who are interested in the current study can write in to inquire about the procedures.

Publications

  • Bedard M, Molloy DW, Squire L, Dubois S, Lever JA, O'Donnell M. The Zarit Burden Interview: a new short version and screening version. Gerontologist. 2001 Oct;41(5):652-7. doi: 10.1093/geront/41.5.652.

    PubMed 11574710
  • Brown EL, Ruggiano N, Page TF, Roberts L, Hristidis V, Whiteman KL, Castro J. CareHeroes Web and Android Apps for Dementia Caregivers: A Feasibility Study. Res Gerontol Nurs. 2016 Jul-Aug;9(4):193-203. doi: 10.3928/19404921-20160229-02. Epub 2016 Mar 4.

    PubMed 29977440
  • Callan JA, Siegle GJ, Abebe K, Black B, Martire L, Schulz R, Reynolds C 3rd, Hall MH. Feasibility of a pocket-PC based cognitive control intervention in dementia spousal caregivers. Aging Ment Health. 2016;20(6):575-82. doi: 10.1080/13607863.2015.1031635. Epub 2015 May 6.

    PubMed 25945597
  • Fogg, B. J. (2009). A behavior model for persuasive design. Paper presented at the Proceedings of the 4th international Conference on Persuasive Technology.

  • Lorca-Cabrera J, Grau C, Marti-Arques R, Raigal-Aran L, Falco-Pegueroles A, Albacar-Rioboo N. Effectiveness of health web-based and mobile app-based interventions designed to improve informal caregiver's well-being and quality of life: A systematic review. Int J Med Inform. 2020 Feb;134:104003. doi: 10.1016/j.ijmedinf.2019.104003. Epub 2019 Nov 23.

    PubMed 31790857
  • McCurdie T, Taneva S, Casselman M, Yeung M, McDaniel C, Ho W, Cafazzo J. mHealth consumer apps: the case for user-centered design. Biomed Instrum Technol. 2012 Fall;Suppl:49-56. doi: 10.2345/0899-8205-46.s2.49. No abstract available.

    PubMed 23039777
  • Rathnayake S, Moyle W, Jones C, Calleja P. mHealth applications as an educational and supportive resource for family carers of people with dementia: An integrative review. Dementia (London). 2019 Oct-Nov;18(7-8):3091-3112. doi: 10.1177/1471301218768903. Epub 2018 Apr 9. No abstract available.

    PubMed 29631492
  • Reyes, A. K., Camargo, J. E., & Díaz, G. M. (2015). Design of a mobile application to support non-pharmacological therapies for people with Alzheimer disease. Paper presented at the International Conference on Smart Health.

  • Sallim AB, Sayampanathan AA, Cuttilan A, Ho R. Prevalence of Mental Health Disorders Among Caregivers of Patients With Alzheimer Disease. J Am Med Dir Assoc. 2015 Dec;16(12):1034-41. doi: 10.1016/j.jamda.2015.09.007.

    PubMed 26593303
  • Sikder AT, Yang FC, Schafer R, Dowling GA, Traeger L, Jain FA. Mentalizing Imagery Therapy Mobile App to Enhance the Mood of Family Dementia Caregivers: Feasibility and Limited Efficacy Testing. JMIR Aging. 2019 Mar 21;2(1):e12850. doi: 10.2196/12850.

    PubMed 31518275
  • Subramaniam M, Chong SA, Vaingankar JA, Abdin E, Chua BY, Chua HC, Eng GK, Heng D, Hia SB, Huang W, Jeyagurunathana A, Kua J, Lee SP, Mahendran R, Magadi H, Malladi S, McCrone P, Pang S, Picco L, Sagayadevan V, Sambasivam R, Seng KH, Seow E, Shafie S, Shahwan S, Tan LL, Yap M, Zhang Y, Ng LL, Prince M. Prevalence of Dementia in People Aged 60 Years and Above: Results from the WiSE Study. J Alzheimers Dis. 2015;45(4):1127-38. doi: 10.3233/JAD-142769.

    PubMed 25672767
  • Yuan Q, Wang P, Tan TH, Devi F, Poremski D, Magadi H, Goveas R, Ng LL, Chong SA, Subramaniam M. Coping Patterns Among Primary Informal Dementia Caregivers in Singapore and Its Impact on Caregivers-Implications of a Latent Class Analysis. Gerontologist. 2021 Jul 13;61(5):680-692. doi: 10.1093/geront/gnaa080.

    PubMed 32592582
  • Yuan Q, Lee YT, Samari E, Zhang Y, Goveas R, Ng LL, Subramaniam M. Evaluating the feasibility and potential effectiveness of a mobile-based intervention to promote the mental health of informal caregivers of persons with dementia in Singapore: Results from a mixed-methods two-arm pilot randomized controlled trial. J Affect Disord. 2026 Apr 15;399:121059. doi: 10.1016/j.jad.2025.121059. Epub 2025 Dec 29.

    PubMed 41475574
  • Lee YT, Yuan Q, Zhang Y, Samari E, Goveas R, Ng LL, Subramaniam M. Evaluating a mobile-based intervention to promote the mental health of informal dementia caregivers in Singapore: Study protocol for a pilot two-armed randomised controlled trial. PLoS One. 2024 Jun 24;19(6):e0305729. doi: 10.1371/journal.pone.0305729. eCollection 2024.

    PubMed 38913625

Questions about this trial

What is this clinical trial studying?

A study testing Kampung Care App in people with Caregiver Burden and Dementia, run by Institute of Mental Health, Singapore at 1 site in Singapore.

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 6 inclusion and 2 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: finished, as of the sponsor's last update on 7 Jan 2026. 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 Singapore. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Baseline depressive symptom (time frame: baseline - before the intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05551533, which also lists 14 linked publications.

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 7 Jan 2026.

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