NCT05551533

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
59

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2022

Geographic Reach
1 country

1 active site

Status
completed

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

September 16, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 22, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2022

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

January 7, 2026

Status Verified

January 1, 2026

Enrollment Period

1.2 years

First QC Date

September 16, 2022

Last Update Submit

January 5, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • Baseline depressive symptom

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

    baseline - before the intervention

  • Post-intervention depressive symptom

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

    within 2 weeks after the intervention

Secondary Outcomes (14)

  • Baseline knowledge of dementia

    baseline - before the intervention

  • Post intervention knowledge of dementia

    within 2 weeks after the intervention

  • Baseline caregiving self-efficacy

    baseline - before the intervention

  • Post intervention caregiving self-efficacy

    within 2 weeks after the intervention

  • Baseline coping strategy

    baseline - before the intervention

  • +9 more secondary outcomes

Study Arms (2)

Intervention

EXPERIMENTAL

To 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.

Other: Kampung Care App

Wait list

NO INTERVENTION

Participants in this group will be put on a wait-list for one month before they can use the app.

Interventions

Please refer to the previous session

Intervention

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinic B, Institute of Mental Health

Singapore, Singapore, 539747, Singapore

Location

Related Publications (14)

  • 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.

    PMID: 11574710BACKGROUND
  • 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.

    PMID: 29977440BACKGROUND
  • 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.

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

    BACKGROUND
  • 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.

    PMID: 31790857BACKGROUND
  • 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.

    PMID: 23039777BACKGROUND
  • 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.

    PMID: 29631492BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 26593303BACKGROUND
  • 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.

    PMID: 31518275BACKGROUND
  • 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.

    PMID: 25672767BACKGROUND
  • 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.

    PMID: 32592582BACKGROUND
  • 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.

  • 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.

Related Links

MeSH Terms

Conditions

Caregiver BurdenDementia

Condition Hierarchy (Ancestors)

Stress, PsychologicalBehavioral SymptomsBehaviorBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Qi Yuan, PhD

    Research Division, Institute of Mental Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Research Fellow

Study Record Dates

First Submitted

September 16, 2022

First Posted

September 22, 2022

Study Start

December 1, 2022

Primary Completion

March 1, 2024

Study Completion

June 1, 2024

Last Updated

January 7, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

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.

Locations