Machine Learning Enabled Management of Behavioural and Psychological Symptoms of Dementia Intervention for Dementia Caregivers
Developing and Testing a Machine Learning Enabled Management of Behavioural and Psychological Symptoms of Dementia Intervention for Dementia Caregivers: A Hybrid Experimental Design Study
2 other identifiers
interventional
550
1 country
1
Brief Summary
Develop and test a machine learning enabled management of behavioural and psychological symptoms of dementia intervention for dementia caregivers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2026
1 active site
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
First Submitted
Initial submission to the registry
February 25, 2026
CompletedFirst Posted
Study publicly available on registry
March 3, 2026
CompletedStudy Start
First participant enrolled
June 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 30, 2027
May 18, 2026
May 1, 2026
1.5 years
February 25, 2026
May 14, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Stress
10-item Perceived Stress Scale; each item will be rated from 0=Never to 4=Very often. Total scores range from 0 to 40.
Baseline (T0), 6 weeks after baseline assessment (T1), 10 weeks after baseline assessment (T2), 20 weeks after baseline assessment (T3), 32 weeks after baseline assessment (T4)
Secondary Outcomes (12)
Depression
Baseline (T0), 6 weeks after baseline assessment (T1), 10 weeks after baseline assessment (T2), 20 weeks after baseline assessment (T3), 32 weeks after baseline assessment (T4)
Sleep Quality
Baseline (T0), 6 weeks after baseline assessment (T1), 10 weeks after baseline assessment (T2), 20 weeks after baseline assessment (T3), 32 weeks after baseline assessment (T4)
Anxiety
Baseline (T0), 6 weeks after baseline assessment (T1), 10 weeks after baseline assessment (T2), 20 weeks after baseline assessment (T3), 32 weeks after baseline assessment (T4)
Physical Health
Baseline (T0), 32 weeks after baseline assessment (T4)
Physical Health
Baseline (T0), 32 weeks after baseline assessment (T4)
- +7 more secondary outcomes
Other Outcomes (1)
Caregiving
Baseline (T0), 6 weeks after baseline assessment (T1), 10 weeks after baseline assessment (T2), 20 weeks after baseline assessment (T3), 32 weeks after baseline assessment (T4)
Study Arms (13)
Active control
ACTIVE COMPARATORActive control
App & Human Coaching + Continue Intervention
EXPERIMENTALFirst-line of coaching: App + Human Coaching Responder
App & Human Coaching + Increase intensity in human coaching
EXPERIMENTALFirst-line of coaching: App + Human Coaching Non-Responder
App & Human Coaching + Booster
EXPERIMENTALFirst-line of coaching: App + Human Coaching Non-Responder
App Coaching + Continue Intervention
EXPERIMENTALFirst-line of coaching: App Coaching Responder
App Coaching + Increase intensity in human coaching
EXPERIMENTALFirst-line of coaching: App Coaching Non-Responder
App Coaching + Booster
EXPERIMENTALFirst-line of coaching: App Coaching Non-Responder
Human Coaching + Continue Intervention
EXPERIMENTALFirst-line of coaching: Human Coaching Responder
Human Coaching + Increase intensity in human coaching
EXPERIMENTALFirst-line of coaching: Human Coaching Non-Responder
Human Coaching + Booster
EXPERIMENTALFirst-line of coaching: Human Coaching Non-Responder
No Coaching + Continue Intervention
EXPERIMENTALFirst-line of coaching: No Coaching Responder
No Coaching + Increase intensity in human coaching
EXPERIMENTALFirst-line of coaching: No Coaching Non-Responder
No Coaching + Booster
EXPERIMENTALFirst-line of coaching: No Coaching Non-Responder
Interventions
No APP based coaching, no human coaching, no rerandomization, no MRT
Continue with existing intervention plan
Increase intensity of human coaching
Add a booster session
Eligibility Criteria
You may qualify if:
- aged 18 above
- family caregiver of an individual with a confirmed medical diagnosis of any type of dementia who has been residing in the community
- having been providing care for ADLs and IADLs for at least 20 hours per week for at least one year prior to recruitment
- have a smartphone
- have mild to moderate stress (the 14-item Chinese version Perceived Stress Scale).
You may not qualify if:
- having participated in any structured mind-body intervention, cognitive therapy, or structured psychosocial intervention in the 6 months prior to recruitment
- having acute psychiatric and medical comorbidities that are potentially life-threatening (e.g. suicidal ideation) or that limit the caregivers' participation or adherence (e.g. acute psychosis)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Education University of Hong Konglead
- The Hong Kong Polytechnic Universitycollaborator
- Lingnan Universitycollaborator
- Columbia Universitycollaborator
- Penn State Universitycollaborator
- The University of Hong Kongcollaborator
- Deakin Universitycollaborator
Study Sites (1)
The Education University of Hong Kong
Hong Kong, Hong Kong
Study Officials
- PRINCIPAL INVESTIGATOR
Kee Lee Chou, PhD
The Education University of Hong Kong
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chair Professor of Social Policy
Study Record Dates
First Submitted
February 25, 2026
First Posted
March 3, 2026
Study Start
June 1, 2026
Primary Completion (Estimated)
November 30, 2027
Study Completion (Estimated)
November 30, 2027
Last Updated
May 18, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will not share