- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06817876
Connecting Caregivers With Community Services: The Care Buddy Platform
Study Overview
Detailed Description
This is a 5-year study with various stages: 1) proof-of-concept stage to design and develop the Care buddy intervention, 2) proof-of-value stage to assess the feasibility, acceptability and satisfaction with the Care buddy intervention among informal caregivers of PWDs, 3) test-bedding stage to assess the efficacy and cost-effectiveness of the Care buddy intervention versus usual care among informal caregivers of PWDs with help of a multi-centre 2-arm RCT and 4) deployment stage to scale up the intervention at multiple centres across Singapore, monitor its adoption and outcomes and assess any organizational and individual barriers to adoption.
By the end of the proposed five-year project, investigators aim to develop and evaluate the technology as well as achieve widespread adoption among caregivers of PWDs. Investigators want to enable easy access to information, provide decisional and social support, improve the reach and uptake of existing community service providers, and assist with coordination among multiple informal and professional caregivers through the journey of dementia caregiving and into the bereavement phase.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Chetna Malhotra, MD, MPH
- Phone Number: +65 65165692
- Email: chetna.malhotra@duke-nus.edu.sg
Study Locations
-
-
Singapore
-
Singapore, Singapore, Singapore
- Recruiting
- Duke-NUS
-
Contact:
- Shimoni Shah, MPH
- Phone Number: 61769 65 65161769
- Email: shimoni@nus.edu.sg
-
Principal Investigator:
- Chetna Malhotra, MD, MPH
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
The inclusion criteria for patients are
- Singaporean/Permanent residents
- Age 21 years of age or older
- Main person or one of the main persons involved in making decisions regarding treatment patient receives or responsible for ensuring the well-being of the patient
- An active primary caregiver for at least 6 months, and planning to remain the primary caregiver for the next 2 years
- Is a family member of the patient with dementia
- Can read and write in English
- Accessible by telephone to schedule interviews
- Has familiarity with use of technology (e.g., computers, tablets, or internet) and is able to complete surveys, forms using digital technology
- Intact cognition determined through the Abbreviated Mental Test (AMT) for those who are ≥ 65 years old.
- Caregivers who score >=9 on the 6-item Zarit Burden scale
Exclusion Criteria:
- Caregivers of patients staying in nursing home or other long-term care facility with no intention of being discharged will not be eligible however, if the patient is admitted to respite care for short/long term duration after being recruited, caregivers can continue to participate.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: CareBuddy
Caregivers of person with dementia who will be randomized in this arm will have access to the CareBuddy mobile app on their phone.
They will be using this app for 1 year and will be followed up every 2 months.
|
Care Buddy mobile intervention will be a one-stop solution for caregivers of dementia patients and help them in their care-giving journey by providing them solutions to manage behavioural problems, physical conditions of their loved one.
The app will be multi-component and will provide tools for the caregiver to manage their stress and burden.
It will provide information on dementia, list of service providers, information on grief, financial support.
This app will provide a platform for all enrolled caregivers to chat with each other and provide social support.
|
|
No Intervention: Usual care
Caregivers of person with dementia who will be randomized in this arm will continue usual care for their loved one.
They will be enrolled for 1 year and will be followed up every 2 months.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Caregiver Psychological well-being
Time Frame: 1 year from data collection
|
Flourish - range - 8 - 56, high score represents a person with many psychological resources and strengths
|
1 year from data collection
|
|
Caregiver social scale
Time Frame: 1 year from data collection
|
Friendship scale - The score range is 0-24.
A high score represents social connectedness and a score of "0" complete social isolation
|
1 year from data collection
|
|
Caregiver Dementia Knowledge
Time Frame: 1 year from data collection
|
The Dementia Knowledge Assessment Tool - range - 0-21.
High score equals to higher knowledge of dementia.
|
1 year from data collection
|
|
Caregiver Impact
Time Frame: 1 year from data collection
|
Revised Memory & Behavior Problem checklist - range - 0-96 Higher score indicates increased impact.
|
1 year from data collection
|
|
Caregiver Burden
Time Frame: 1 year from data collection
|
Zarit Burden scale - range 0-88.
0 - 21 little or no burden, 21 - 40 mild to moderate burden, 41 - 60 moderate to severe burden, 61 - 88 severe burden >34 - clinically significant burden.
|
1 year from data collection
|
|
Caregiver Stress
Time Frame: 1 year from data collection
|
Perceived Stress Scale: Scoring: PSS scores are obtained by reversing responses (e.g., 0 = 4, 1 = 3, 2 = 2, 3 = 1 & 4 = 0) to the four positively stated items (items 4, 5, 7, & 8) and then summing across all scale items.
|
1 year from data collection
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Health care costs
Time Frame: 1 year from data collection
|
Health care costs, hospitalizations and emergency room visits for caregivers and PWDs will be obtained from patient billing data.
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1 year from data collection
|
Collaborators and Investigators
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
- 2022-309
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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