NCT06817876

Brief Summary

The study aims to develop a mobile-app (Care Buddy) which will be a one-stop integrated source of information and technology-based solutions for caregivers of people with dementia (PWDs). Study aims to bring caregivers into closer partnerships with the wider ecosystem (e.g., healthcare practitioners, community services, peer support, and care service providers) which will ultimately improve outcomes for both PWDs and their caregivers.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
210

participants targeted

Target at P75+ for not_applicable

Timeline
13mo left

Started Apr 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress51%
Apr 2025May 2027

First Submitted

Initial submission to the registry

February 5, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 10, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2025

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2027

Last Updated

April 15, 2026

Status Verified

October 1, 2025

Enrollment Period

1.2 years

First QC Date

February 5, 2025

Last Update Submit

April 13, 2026

Conditions

Outcome Measures

Primary Outcomes (6)

  • Caregiver Psychological well-being

    Flourish - range - 8 - 56, high score represents a person with many psychological resources and strengths

    1 year from data collection

  • Caregiver social scale

    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

    The Dementia Knowledge Assessment Tool - range - 0-21. High score equals to higher knowledge of dementia.

    1 year from data collection

  • Caregiver Impact

    Revised Memory \& Behavior Problem checklist - range - 0-96 Higher score indicates increased impact.

    1 year from data collection

  • Caregiver Burden

    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

    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 Outcomes (1)

  • Health care costs

    1 year from data collection

Study Arms (2)

CareBuddy

EXPERIMENTAL

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.

Device: Care Buddy

Usual care

NO INTERVENTION

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.

Interventions

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.

CareBuddy

Eligibility Criteria

Age21 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke-NUS

Singapore, Singapore, Singapore

RECRUITING

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Central Study Contacts

Chetna Malhotra, MD, MPH

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 5, 2025

First Posted

February 10, 2025

Study Start

April 1, 2025

Primary Completion (Estimated)

May 31, 2026

Study Completion (Estimated)

May 31, 2027

Last Updated

April 15, 2026

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations