Ignite Creation Date:
2024-05-06 @ 6:07 PM
Last Modification Date:
2024-10-26 @ 2:42 PM
Study NCT ID:
NCT05551533
Status:
RECRUITING
Last Update Posted:
2024-02-08
First Post:
2022-09-16
Brief Title:
Mobile App Intervention for Informal Dementia Caregivers
Sponsor:
Institute of Mental Health Singapore
Organization:
Institute of Mental Health Singapore
Study Overview
Official Title:
Design and Pilot-test of an Innovative Mobile-based Intervention to Promote Mental Health of Informal Dementia Caregivers Through User-Centered Design
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 51934 older adults As the population is aging in Singapore and the fact that the incidence of dementia doubles with every 63-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 ie 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 Objectives 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
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 ie 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 Objectives 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None