Developing and Testing a Machine Learning Enabled Management of Behavioural and Psychological Symptoms of Dementia Intervention for Dementia Caregivers: A Hybrid Experimental Design Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 550
- 试验地点
- 1
- 主要终点
- Stress
研究概览
简要总结
Develop and test a machine learning enabled management of behavioural and psychological symptoms of dementia intervention for dementia caregivers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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).
排除标准
- •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)
研究组 & 干预措施
App Coaching + Continue Intervention
First-line of coaching: App Coaching Responder
干预措施: Behavioral: Continue (Behavioral)
App Coaching + Increase intensity in human coaching
First-line of coaching: App Coaching Non-Responder
干预措施: Behavioral: Enhance human coaching (Behavioral)
App Coaching + Booster
First-line of coaching: App Coaching Non-Responder
干预措施: Behavioral: Booster (Behavioral)
Human Coaching + Continue Intervention
First-line of coaching: Human Coaching Responder
干预措施: Behavioral: Continue (Behavioral)
Human Coaching + Increase intensity in human coaching
First-line of coaching: Human Coaching Non-Responder
干预措施: Behavioral: Enhance human coaching (Behavioral)
Human Coaching + Booster
First-line of coaching: Human Coaching Non-Responder
干预措施: Behavioral: Booster (Behavioral)
No Coaching + Continue Intervention
First-line of coaching: No Coaching Responder
干预措施: Behavioral: Continue (Behavioral)
No Coaching + Increase intensity in human coaching
First-line of coaching: No Coaching Non-Responder
干预措施: Behavioral: Enhance human coaching (Behavioral)
No Coaching + Booster
First-line of coaching: No Coaching Non-Responder
干预措施: Behavioral: Booster (Behavioral)
Active control
Active control
干预措施: Active Control (Behavioral)
App & Human Coaching + Continue Intervention
First-line of coaching: App + Human Coaching Responder
干预措施: Behavioral: Continue (Behavioral)
App & Human Coaching + Increase intensity in human coaching
First-line of coaching: App + Human Coaching Non-Responder
干预措施: Behavioral: Enhance human coaching (Behavioral)
App & Human Coaching + Booster
First-line of coaching: App + Human Coaching Non-Responder
干预措施: Behavioral: Booster (Behavioral)
结局指标
主要结局
Stress
时间窗: 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.
次要结局
- 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))
- 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))
研究者
Chou Kee Lee
Chair Professor of Social Policy
Education University of Hong Kong