Clinical trial NCT05551533: Mobile App Intervention for Informal Dementia Caregivers
Official title: Design and Pilot-test of an Innovative Mobile-based Intervention to Promote Mental Health of Informal Dementia Caregivers Through User-Centered Design
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Caregiver Burden
Dementia
Digital Health
Lead sponsor: Institute of Mental Health, Singapore
Sponsor class: OTHER
Collaborators: name: National Healthcare Group, Singapore
First posted: 2022-09-22
Enrollment: 60
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1. Caregivers who are pregnant
2. caregivers with vision and hearing problems

Primary outcomes:
measure: Baseline depressive symptom
timeFrame: baseline - before the intervention
measure: Post-intervention depressive symptom
timeFrame: within 2 weeks after the intervention
Secondary outcomes:
measure: Baseline knowledge of dementia
timeFrame: baseline - before the intervention
measure: Post intervention knowledge of dementia
timeFrame: within 2 weeks after the intervention
measure: Baseline caregiving self-efficacy
timeFrame: baseline - before the intervention
measure: Post intervention caregiving self-efficacy
timeFrame: within 2 weeks after the intervention
measure: Baseline coping strategy
timeFrame: baseline - before the intervention
measure: Post intervention coping strategy
timeFrame: within 2 weeks after the intervention
measure: Baseline positive aspects of caregiving
timeFrame: baseline - before the intervention
measure: Post intervention positive aspects of caregiving
timeFrame: within 2 weeks after the intervention
measure: Baseline caregiver burden
timeFrame: baseline - before the intervention
measure: Post intervention caregiver burden
timeFrame: within 2 weeks after the intervention
measure: Baseline anxiety level
timeFrame: baseline - before the intervention
measure: Post intervention anxiety level
timeFrame: within 2 weeks after the intervention
measure: Baseline mental well-being
timeFrame: baseline - before the intervention
measure: Post intervention mental well-being
timeFrame: within 2 weeks after the intervention
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Clinic B, Institute of Mental Health
Study officials:
affiliation: Research Division, Institute of Mental Health
name: Qi Yuan, PhD
role: PRINCIPAL_INVESTIGATOR
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