- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05551533
Mobile App Intervention for Informal Dementia Caregivers
Design and Pilot-test of an Innovative Mobile-based Intervention to Promote Mental Health of Informal Dementia Caregivers Through User-Centered Design
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Qi Yuan, PhD
- Phone Number: +6563893624
- Email: Qi_YUAN@imh.com.sg
Study Locations
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Singapore, Singapore, 539747
- Recruiting
- Clinic B, Institute of Mental Health
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Contact:
- Qi Yuan, PhD
- Phone Number: 63893624
- Email: Qi_YUAN@imh.com.sg
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention
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.
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Please refer to the previous session
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No Intervention: Wait list
Participants in this group will be put on a wait-list for one month before they can use the app.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Baseline depressive symptom
Time Frame: baseline - before the intervention
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Centre for Epidemiological Study Scale (0-60), with a higher score indicating a more severe depressive symptom
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baseline - before the intervention
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Post-intervention depressive symptom
Time Frame: within 2 weeks after the intervention
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Centre for Epidemiological Study Scale (0-60), with a higher score indicating a more severe depressive symptom
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within 2 weeks after the intervention
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Baseline knowledge of dementia
Time Frame: baseline - before the intervention
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Dementia Knowledge Assessment Scale (0-54), with higher score indicating better knowledge on dementia
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baseline - before the intervention
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Post intervention knowledge of dementia
Time Frame: within 2 weeks after the intervention
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Dementia Knowledge Assessment Scale (0-54), with higher score indicating better knowledge on dementia
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within 2 weeks after the intervention
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Baseline caregiving self-efficacy
Time Frame: baseline - before the intervention
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Revised Scale for Caregiving Self-efficacy (0-100), with higher score indicating more confidence in caregiving
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baseline - before the intervention
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Post intervention caregiving self-efficacy
Time Frame: within 2 weeks after the intervention
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Revised Scale for Caregiving Self-efficacy (0-100), with higher score indicating more confidence in caregiving
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within 2 weeks after the intervention
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Baseline coping strategy
Time Frame: baseline - before the intervention
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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
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baseline - before the intervention
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Post intervention coping strategy
Time Frame: within 2 weeks after the intervention
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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
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within 2 weeks after the intervention
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Baseline positive aspects of caregiving
Time Frame: baseline - before the intervention
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Positive Aspects of Caregiving Scale (9-45) - with a higher score indicates a more positive caregiving experience
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baseline - before the intervention
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Post intervention positive aspects of caregiving
Time Frame: within 2 weeks after the intervention
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Positive Aspects of Caregiving Scale (9-45) - with a higher score indicates a more positive caregiving experience
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within 2 weeks after the intervention
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Baseline caregiver burden
Time Frame: baseline - before the intervention
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Zarit burden interview (0-88) - with a higher score indicating higher perceived caregiving burden
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baseline - before the intervention
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Post intervention caregiver burden
Time Frame: within 2 weeks after the intervention
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Zarit burden interview (0-88) - with a higher score indicating higher perceived caregiving burden
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within 2 weeks after the intervention
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Baseline anxiety level
Time Frame: baseline - before the intervention
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Generalized Anxiety Disorder 7-item scale (0-21) - with a higher score indicating higher anxiety level
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baseline - before the intervention
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Post intervention anxiety level
Time Frame: within 2 weeks after the intervention
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Generalized Anxiety Disorder 7-item scale (0-21) - with a higher score indicating higher anxiety level
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within 2 weeks after the intervention
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Baseline mental well-being
Time Frame: baseline - before the intervention
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Short Positive Mental Health instrument (1-6) - with a higher score indicating higher positive mental health
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baseline - before the intervention
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Post intervention mental well-being
Time Frame: within 2 weeks after the intervention
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Short Positive Mental Health instrument (1-6) - with a higher score indicating higher positive mental health
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within 2 weeks after the intervention
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Qi Yuan, PhD, Research Division, Institute of Mental Health
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- Fogg, B. J. (2009). A behavior model for persuasive design. Paper presented at the Proceedings of the 4th international Conference on Persuasive Technology.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PHG20.P.I.2.6
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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