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Mobile App Intervention for Informal Dementia Caregivers

Primary Purpose

Caregiver Burden, Dementia, Digital Health

Status
Recruiting
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
Kampung Care App
Sponsored by
Institute of Mental Health, Singapore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Caregiver Burden

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Clinic B, Institute of Mental HealthRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Wait list

Arm Description

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.

Participants in this group will be put on a wait-list for one month before they can use the app.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
September 16, 2022
Last Updated
March 7, 2023
Sponsor
Institute of Mental Health, Singapore
Collaborators
National Healthcare Group, Singapore
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1. Study Identification

Unique Protocol Identification Number
NCT05551533
Brief Title
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

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2022 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
October 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Institute of Mental Health, Singapore
Collaborators
National Healthcare Group, Singapore

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Caregiver Burden, Dementia, Digital Health

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Wait list
Arm Type
No Intervention
Arm Description
Participants in this group will be put on a wait-list for one month before they can use the app.
Intervention Type
Other
Intervention Name(s)
Kampung Care App
Intervention Description
Please refer to the previous session
Primary Outcome Measure Information:
Title
Baseline depressive symptom
Description
Centre for Epidemiological Study Scale (0-60), with a higher score indicating a more severe depressive symptom
Time Frame
baseline - before the intervention
Title
Post-intervention depressive symptom
Description
Centre for Epidemiological Study Scale (0-60), with a higher score indicating a more severe depressive symptom
Time Frame
within 2 weeks after the intervention
Secondary Outcome Measure Information:
Title
Baseline knowledge of dementia
Description
Dementia Knowledge Assessment Scale (0-54), with higher score indicating better knowledge on dementia
Time Frame
baseline - before the intervention
Title
Post intervention knowledge of dementia
Description
Dementia Knowledge Assessment Scale (0-54), with higher score indicating better knowledge on dementia
Time Frame
within 2 weeks after the intervention
Title
Baseline caregiving self-efficacy
Description
Revised Scale for Caregiving Self-efficacy (0-100), with higher score indicating more confidence in caregiving
Time Frame
baseline - before the intervention
Title
Post intervention caregiving self-efficacy
Description
Revised Scale for Caregiving Self-efficacy (0-100), with higher score indicating more confidence in caregiving
Time Frame
within 2 weeks after the intervention
Title
Baseline coping strategy
Description
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
Time Frame
baseline - before the intervention
Title
Post intervention coping strategy
Description
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
Time Frame
within 2 weeks after the intervention
Title
Baseline positive aspects of caregiving
Description
Positive Aspects of Caregiving Scale (9-45) - with a higher score indicates a more positive caregiving experience
Time Frame
baseline - before the intervention
Title
Post intervention positive aspects of caregiving
Description
Positive Aspects of Caregiving Scale (9-45) - with a higher score indicates a more positive caregiving experience
Time Frame
within 2 weeks after the intervention
Title
Baseline caregiver burden
Description
Zarit burden interview (0-88) - with a higher score indicating higher perceived caregiving burden
Time Frame
baseline - before the intervention
Title
Post intervention caregiver burden
Description
Zarit burden interview (0-88) - with a higher score indicating higher perceived caregiving burden
Time Frame
within 2 weeks after the intervention
Title
Baseline anxiety level
Description
Generalized Anxiety Disorder 7-item scale (0-21) - with a higher score indicating higher anxiety level
Time Frame
baseline - before the intervention
Title
Post intervention anxiety level
Description
Generalized Anxiety Disorder 7-item scale (0-21) - with a higher score indicating higher anxiety level
Time Frame
within 2 weeks after the intervention
Title
Baseline mental well-being
Description
Short Positive Mental Health instrument (1-6) - with a higher score indicating higher positive mental health
Time Frame
baseline - before the intervention
Title
Post intervention mental well-being
Description
Short Positive Mental Health instrument (1-6) - with a higher score indicating higher positive mental health
Time Frame
within 2 weeks after the intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Qi Yuan, PhD
Phone
+6563893624
Email
Qi_YUAN@imh.com.sg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Qi Yuan, PhD
Organizational Affiliation
Research Division, Institute of Mental Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinic B, Institute of Mental Health
City
Singapore
ZIP/Postal Code
539747
Country
Singapore
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qi Yuan, PhD
Phone
63893624
Email
Qi_YUAN@imh.com.sg

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Our IRB requires a signed research collaboration agreement before we can share the data. Parties who are interested in the current study can write in to inquire about the procedures.
Citations:
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11574710
Citation
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Citation
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Links:
URL
https://www.alz.co.uk/research/WorldAlzheimerReport2015.pdf
Description
World Alzheimer Report 2015, The Global Impact of Dementia: An Analysis of Prevalence, Incidence, Cost and Trends
URL
https://www.imda.gov.sg/-/media/imda/files/industry-development/fact-and-figures/infocomm-survey-reports/hh2017-survey.pdf?la=en
Description
ANNUAL SURVEY ON INFOCOMM USAGE IN HOUSEHOLDS AND BY INDIVIDUALS FOR 2017

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Mobile App Intervention for Informal Dementia Caregivers

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