Dementia Caregiver
Conditions
Keywords
Hybrid factorial - Sequential Multiple Assignment Randomized Trial, Micro Randomized Trial experimental design, machine learning, intervention, dementia caregiver
Brief summary
Develop and test a machine learning enabled management of behavioural and psychological symptoms of dementia intervention for dementia caregivers.
Interventions
BEHAVIORALActive Control
No APP based coaching, no human coaching, no rerandomization, no MRT
BEHAVIORALBehavioral: Continue
Continue with existing intervention plan
BEHAVIORALBehavioral: Enhance human coaching
Increase intensity of human coaching
BEHAVIORALBehavioral: Booster
Add a booster session
Sponsors
Education University of Hong Kong
The Hong Kong Polytechnic University
Lingnan University
Columbia University
Penn State University
The University of Hong Kong
Deakin University
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
Hybrid factorial - Sequential Multiple Assignment Randomized Trial (SMART), Micro Randomized Trial (MRT) experimental design with a 2x2+1 factorial design (with five arms) randomized clinical trial, 2 stage SMART and three MRTs
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Stress | 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
| Measure | Time frame | Description |
|---|---|---|
| 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) | Patient Health Questionnaire-9; Each item will be rated from 0=Not at all to 3=nearly everyday. Total scores range from 0 to 27 |
| 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) | Pittsburgh Sleep Quality Index; each item will be rated from 0=No difficulty to 3=Severe difficulty. Total scores range from 0 to 21. Higher scores indicating poorer sleep quality |
| 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) | Generalised Anxiety Disorder; each item will be rated from 0=not at all to 3=nearly every day. Total score range from 0 to 21. |
| Physical Health | Baseline (T0), 32 weeks after baseline assessment (T4) | Lawton Instrumental Activities of Daily Living; each item will be rated 0=dependent to 1=independent. Total scores range from 0 to 8. |
| Physical Symptoms | Baseline (T0), 32 weeks after baseline assessment (T4) | Wahler Physical Symptoms Inventory; each item will be rated from 0=almost never agree to 5=agree almost every day. Total score range from 0 to 210. |
| Chronic Illness | Baseline (T0), 32 weeks after baseline assessment (T4) | Participants will indicate any presence of chronic illness (e.g., diabetes, asthma, high blood pressure). |
| 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) | 12-item Zarit Burden Interview Scale ; each item will be rated from 0=Never to 4=Nearly always. Total scores range from 0 to 48. |
| 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) | 18-item Ryff Psychological Well-Being scale, each item range from 1-strongly agree to 7-strongly disagree. Total score range from 18-126. |
| 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) | 12-item Short Form Health Survey, Version 2 (SF-12v2). Item responses are aggregated using standard scoring procedures to generate two summary scores: physical and mental. Higher scores indicating better health status |
| 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) | Neuropsychiatric Inventory Questionnaire; classified each of the 12 domain into presence of symptom, frequency, severity, and caregiver distress. |
| 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) | Revised Memory and Behavior Problems Checklist; a 24-item checklist from 0=never occurred/not at all to 4=daily/extremely. Higher score indicate more frequent behavioral problems/caregiver distress |
Countries
Hong Kong
Contacts
PRINCIPAL_INVESTIGATORKee Lee Chou, PhD
The Education University of Hong Kong
Outcome results
None listed