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| ID | Type | Description | Link |
|---|---|---|---|
| 22231921 | Other Grant/Funding Number | Research Fund Secretariat, Health Bureau |
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| Name | Class |
|---|---|
| The Hong Kong Polytechnic University | OTHER |
| Lingnan University | OTHER |
| Columbia University | OTHER |
| Penn State University |
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Develop and test a machine learning enabled management of behavioural and psychological symptoms of dementia intervention for dementia caregivers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active control | Active Comparator | Active control |
|
| App & Human Coaching + Continue Intervention | Experimental | First-line of coaching: App + Human Coaching Responder |
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| App & Human Coaching + Increase intensity in human coaching | Experimental | First-line of coaching: App + Human Coaching Non-Responder |
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| App & Human Coaching + Booster | Experimental | First-line of coaching: App + Human Coaching Non-Responder |
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| App Coaching + Continue Intervention | Experimental | First-line of coaching: App Coaching Responder |
|
| App Coaching + Increase intensity in human coaching | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active Control | Behavioral | No APP based coaching, no human coaching, no rerandomization, no MRT |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Depression | 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 | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Caregiving | Revised Scale for Caregiving Self-efficacy; 15-item scale. Total score is 100. | 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) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kee Lee Chou, PhD | The Education University of Hong Kong | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Education University of Hong Kong | Hong Kong | Hong Kong |
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| OTHER |
| The University of Hong Kong | OTHER |
| Deakin University | OTHER |
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
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First-line of coaching: App Coaching Non-Responder
|
| App Coaching + Booster | Experimental | First-line of coaching: App Coaching Non-Responder |
|
| Human Coaching + Continue Intervention | Experimental | First-line of coaching: Human Coaching Responder |
|
| Human Coaching + Increase intensity in human coaching | Experimental | First-line of coaching: Human Coaching Non-Responder |
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| Human Coaching + Booster | Experimental | First-line of coaching: Human Coaching Non-Responder |
|
| No Coaching + Continue Intervention | Experimental | First-line of coaching: No Coaching Responder |
|
| No Coaching + Increase intensity in human coaching | Experimental | First-line of coaching: No Coaching Non-Responder |
|
| No Coaching + Booster | Experimental | First-line of coaching: No Coaching Non-Responder |
|
| Behavioral: Continue | Behavioral | Continue with existing intervention plan |
|
| Behavioral: Enhance human coaching | Behavioral | Increase intensity of human coaching |
|
| Behavioral: Booster | Behavioral | Add a booster session |
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| Sleep Quality |
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 |
| 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 | 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. | 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 | Lawton Instrumental Activities of Daily Living; each item will be rated 0=dependent to 1=independent. Total scores range from 0 to 8. | Baseline (T0), 32 weeks after baseline assessment (T4) |
| Physical Health | Activities of Daily Living; each item will be rate from 0=dependent to 5/10=independent. Total scores range from 0 to 100. | Baseline (T0), 32 weeks after baseline assessment (T4) |
| Physical Symptoms | 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. | Baseline (T0), 32 weeks after baseline assessment (T4) |
| Chronic Illness | Participants will indicate any presence of chronic illness (e.g., diabetes, asthma, high blood pressure). | Baseline (T0), 32 weeks after baseline assessment (T4) |
| Caregiver Burden | 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. | 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 | 18-item Ryff Psychological Well-Being scale, each item range from 1-strongly agree to 7-strongly disagree. Total score range from 18-126. | 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 | 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 | 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 | Neuropsychiatric Inventory Questionnaire; classified each of the 12 domain into presence of symptom, frequency, severity, and caregiver distress. | 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 | 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 | 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) |