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Completed

NCT Number: NCT05551533

Mobile App Intervention for Informal Dementia Caregivers

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.

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Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinic B, Institute of Mental Health

Singapore, 539747

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

Kampung Care App

Other

Please refer to the previous session

Primary outcomes

  1. Baseline depressive symptom

    Time frame: baseline - before the intervention

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

  2. Post-intervention depressive symptom

    Time frame: within 2 weeks after the intervention

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

Secondary outcomes

  1. Baseline knowledge of dementia

    Time frame: baseline - before the intervention

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

  2. Post intervention knowledge of dementia

    Time frame: within 2 weeks after the intervention

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

  3. Baseline caregiving self-efficacy

    Time frame: baseline - before the intervention

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

  4. Post intervention caregiving self-efficacy

    Time frame: within 2 weeks after the intervention

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

  5. Baseline coping strategy

    Time frame: baseline - before the intervention

    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

  6. Post intervention coping strategy

    Time frame: within 2 weeks after the intervention

    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

  7. Baseline positive aspects of caregiving

    Time frame: baseline - before the intervention

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

  8. Post intervention positive aspects of caregiving

    Time frame: within 2 weeks after the intervention

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

  9. Baseline caregiver burden

    Time frame: baseline - before the intervention

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

  10. Post intervention caregiver burden

    Time frame: within 2 weeks after the intervention

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

  11. Baseline anxiety level

    Time frame: baseline - before the intervention

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

  12. Post intervention anxiety level

    Time frame: within 2 weeks after the intervention

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

  13. Baseline mental well-being

    Time frame: baseline - before the intervention

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

  14. Post intervention mental well-being

    Time frame: within 2 weeks after the intervention

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

Sponsors and collaborators

Lead sponsor

Institute of Mental Health, Singapore

Other

Collaborators

  • National Healthcare Group, Singapore

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Sep 22, 2022
Registry last updated
Jan 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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