Mobile App Intervention for Informal Dementia Caregivers

Study Overview
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Brief Summary
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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 100 participants in total - 50 will be required to use the app for one month while another 50 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.

Detailed Description
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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.

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

Conditions
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Caregiver Burden, Dementia, Digital Health

Intervention / Treatment
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* Other: Kampung Care App


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>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<br>* Please refer to the previous session<br>|
| No Intervention: Wait list<br>Participants in this group will be put on a wait-list for one month before they can use the app. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Baseline knowledge of dementia | Dementia Knowledge Assessment Scale (0-54), with higher score indicating better knowledge on dementia | baseline - before the intervention | 
| Post intervention knowledge of dementia | Dementia Knowledge Assessment Scale (0-54), with higher score indicating better knowledge on dementia | within 2 weeks after the intervention | 
| Baseline caregiving self-efficacy | Revised Scale for Caregiving Self-efficacy (0-100), with higher score indicating more confidence in caregiving | baseline - before the intervention | 
| Post intervention caregiving self-efficacy | Revised Scale for Caregiving Self-efficacy (0-100), with higher score indicating more confidence in caregiving | within 2 weeks after the intervention | 
| 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 | baseline - before the intervention | 
| 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 | within 2 weeks after the intervention | 
| Baseline positive aspects of caregiving | Positive Aspects of Caregiving Scale (9-45) - with a higher score indicates a more positive caregiving experience | baseline - before the intervention | 
| Post intervention positive aspects of caregiving | Positive Aspects of Caregiving Scale (9-45) - with a higher score indicates a more positive caregiving experience | within 2 weeks after the intervention | 
| Baseline caregiver burden | Zarit burden interview (0-88) - with a higher score indicating higher perceived caregiving burden | baseline - before the intervention | 
| Post intervention caregiver burden | Zarit burden interview (0-88) - with a higher score indicating higher perceived caregiving burden | within 2 weeks after the intervention | 
| Baseline anxiety level | Generalized Anxiety Disorder 7-item scale (0-21) - with a higher score indicating higher anxiety level | baseline - before the intervention | 
| Post intervention anxiety level | Generalized Anxiety Disorder 7-item scale (0-21) - with a higher score indicating higher anxiety level | within 2 weeks after the intervention | 
| Baseline mental well-being | Short Positive Mental Health instrument (1-6) - with a higher score indicating higher positive mental health | baseline - before the intervention | 
| Post intervention mental well-being | Short Positive Mental Health instrument (1-6) - with a higher score indicating higher positive mental health | within 2 weeks after the intervention |