Supporting Caregivers of Veterans With TBI and Mixed Dementia: The REACH Hope Behavioral Intervention
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- Change from baseline Burden at three months
研究概览
简要总结
This three-year randomized clinical trial will evaluate a behavioral intervention for caregivers of Veterans with traumatic brain injury (TBI) and Alzheimer's dementia or mixed Dementia (AD/MD) to reduce caregiver depression, anxiety and burden, and improve veterans' health management. The study will combine and deliver two award-winning behavioral interventions - REACH VA (Resources for Enhancing All Caregivers Health in Department of Veterans Affairs) and the DoD's Virtual Hope Box, which we call REACH Hope. Both REACH and Hope Box have evidence of effectiveness individually but have not been delivered together for caregivers supporting veterans with complex neurodegenerative diagnoses and health conditions. Our primary hypothesis is that REACH Hope will improve caregivers' quality of life as measured by reduced burden.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (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
- 否
入选标准
- •primary caregiver for person with diagnosis of TBI and subsequent dementia
- •at least one activity of daily living limitation or 2 or more instrumental activity of daily living limitation
- •provide 4 or more hours of care per day for at least 6 months
- •endorse a score of at least high burden (>8) on the Zarit Burden Inventory-4
排除标准
- •no mobile telephone or electronic device that can accept the Hope Box application
- •current diagnosis of schizophrenia or other major mental illness
- •auditory impairment that would make telephone use difficult
结局指标
主要结局
Change from baseline Burden at three months
时间窗: three months
Measured by the Zarit Burden Inventory- 12
Change from baseline Burden at six months
时间窗: six months
Measured by the Zarit Burden Inventory- 12
次要结局
- Change from baseline Anxiety at three months(Three months)
- Change from baseline Caregiving self-efficacy at three months(three months)
- Change from baseline Depression at three months(Three months)
- Change from baseline Depression at six months(Six months)
- Change from baseline Anxiety at six months(six months)
- Change from baseline Caregiving self-efficacy at six months(six months)