Developing and Testing a Machine Learning Enabled Management of Behavioural and Psychological Symptoms of Dementia Intervention for Dementia Caregivers: A Hybrid Experimental Design Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 550
- Locations
- 1
- Primary Endpoint
- Stress
Study Overview
Brief Summary
Develop and test a machine learning enabled management of behavioural and psychological symptoms of dementia intervention for dementia caregivers.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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).
Exclusion Criteria
- •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)
Arms & Interventions
Active control
Active control
Intervention: Active Control (Behavioral)
App & Human Coaching + Continue Intervention
First-line of coaching: App + Human Coaching Responder
Intervention: Behavioral: Continue (Behavioral)
App & Human Coaching + Increase intensity in human coaching
First-line of coaching: App + Human Coaching Non-Responder
Intervention: Behavioral: Enhance human coaching (Behavioral)
App & Human Coaching + Booster
First-line of coaching: App + Human Coaching Non-Responder
Intervention: Behavioral: Booster (Behavioral)
App Coaching + Continue Intervention
First-line of coaching: App Coaching Responder
Intervention: Behavioral: Continue (Behavioral)
Human Coaching + Continue Intervention
First-line of coaching: Human Coaching Responder
Intervention: Behavioral: Continue (Behavioral)
Human Coaching + Increase intensity in human coaching
First-line of coaching: Human Coaching Non-Responder
Intervention: Behavioral: Enhance human coaching (Behavioral)
No Coaching + Continue Intervention
First-line of coaching: No Coaching Responder
Intervention: Behavioral: Continue (Behavioral)
No Coaching + Increase intensity in human coaching
First-line of coaching: No Coaching Non-Responder
Intervention: Behavioral: Enhance human coaching (Behavioral)
No Coaching + Booster
First-line of coaching: No Coaching Non-Responder
Intervention: Behavioral: Booster (Behavioral)
App Coaching + Increase intensity in human coaching
First-line of coaching: App Coaching Non-Responder
Intervention: Behavioral: Enhance human coaching (Behavioral)
App Coaching + Booster
First-line of coaching: App Coaching Non-Responder
Intervention: Behavioral: Booster (Behavioral)
Human Coaching + Booster
First-line of coaching: Human Coaching Non-Responder
Intervention: Behavioral: Booster (Behavioral)
Outcomes
Primary Outcomes
Stress
Time Frame: 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)
10-item Perceived Stress Scale; each item will be rated from 0=Never to 4=Very often. Total scores range from 0 to 40.
Secondary Outcomes
- Neuropsychiatric(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))
- 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))
- Physical and Mental Health(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))
- 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 Symptoms(Baseline (T0), 32 weeks after baseline assessment (T4))
- Chronic Illness(Baseline (T0), 32 weeks after baseline assessment (T4))
- Caregiver Burden(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))
- Psychological Well-Being(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))
- Memory and Behaviour Problems(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))
Investigators
Chou Kee Lee
Chair Professor of Social Policy
Education University of Hong Kong