Developing and Evaluating In-Home Supportive Technology for Dementia Caregivers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 78
- 试验地点
- 10
- 主要终点
- Zarit Burden Interview-Short Form
研究概览
简要总结
This study aims to develop and evaluate in-home assistive technology that is designed to alleviate anxiety, burden, and loneliness in spousal and familial caregivers of individuals with Alzheimer's disease and frontotemporal dementia.
详细描述
This study aims to develop, refine, and evaluate a hardware/software system designed to integrate in-home sensors and devices, social connection, and Internet-of-Things (i.e., devices that can be controlled and communicated with via the internet) technologies to create a more supportive and safe home environment for caregivers and people with dementia. The system monitors troublesome behaviors in people with dementia (e.g., wandering), and targets mechanisms (e.g., worry, social isolation) thought to link behavioral symptoms in people with dementia with adverse caregiver outcomes (declines in health and well-being). The system is designed to minimize demands on caregivers' limited time and energy and to provide a platform for data collection that can be used by researchers and care professionals.
Hypotheses:
- Caregivers in the full operation condition will have fewer negative effects of caregiving (lower burden, higher mental and physical health, higher well-being) than those in the limited home safety condition.
- Greater use of the social networking features of the system will be associated with fewer caregiver depressive symptoms.
- Greater utilization of the home safety features of the system will be associated with fewer caregiver anxiety symptoms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Investigator)
盲法说明
Identical system is installed in all homes regardless of treatment arm. The member of research team who does the installation will now know which treatment arm has been assigned. Initiating the features of the system appropriate to the assigned treatment arm is done remotely by a member of the People Power staff (who has no contact with the participants) following the installation.
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
- •Caregivers are fluent/literate in English
- •Caregivers currently reside with spouse/family member with dementia
- •Caregivers primarily use an iPhone
- •Caregiver has wireless internet in home
排除标准
- •Caregivers providing care for individuals with known non-neurodegenerative conditions affecting behavior and cognition
- •Caregivers providing care for individuals with longstanding Axis I psychiatric disorder
- •Caregivers providing care for individuals with metabolic disorder or major organ dysfunction
- •Caregivers providing care for individuals with alcohol abuse or dependence (within 5 years of dementia onset)
- •Caregivers providing care for individuals with head trauma with loss of consciousness greater than 30 minutes
- •Caregivers providing care for individuals with contraindications to MRI imaging
- •Caregivers providing care for individuals with large confluent white matter lesions
- •Caregivers providing care for individuals with significant systemic medical illness
- •Caregivers providing care for individuals who use a medication likely to affect central nervous system functions adversely
- •If you live in the San Francisco Bay Area, Las Vegas (Clark County), Orange County, Los Angeles County, or Oregon, you may complete the following screening questionnaire to determine your eligibility for participation: https://bit.ly/UCBDC Upon completion of the screening questionnaire, the UC Berkeley research team will follow up soon after by email or phone to confirm your eligibility status.
结局指标
主要结局
Zarit Burden Interview-Short Form
时间窗: 9 months after baseline
Questionnaire to measure caregiver burden (Zarit, Reever, \& Bach-Peterson, 1980). 12 items are rated on 0-4 scale. Range: 0-48. No subscales. Higher scores represent worse outcomes.
Center for Epidemiological Studies Depression Scale (CES-D)
时间窗: 9 months after baseline
Questionnaire to measure depression (Radloff, 1977). 20 items are rated on a 0-3 scale and summed (range = 0-60). There are no subscales. Higher scores represent worse outcomes. The clinical cut-off is usually set at a score of 16.
Beck Anxiety Inventory (BAI)
时间窗: 9 months after baseline
Questionnaire to measure anxiety (Beck, Epstein, Brown, \& Steer, 1988). 20 items are rated on a 0-3 scale and summed (range= 0-60). Higher scores indicate worse outcomes. There are no subscales. A score greater than 36 is considered to be clinically significant.
Satisfaction With Life Scale
时间窗: 9 months after baseline
Questionnaire measuring overall life satisfaction and well-being (Diener, Emmons, Larsen, \& Griffin, 1985). 5 items scored on a 1-7 scale and summed (Range = 5-35). Lower scores indicate worse outcomes. A score of 20 is considered neutral with higher scores considered increasingly more satisfied and lower scores considered increasingly more dissatisfied.
次要结局
未报告次要终点
研究者
Robert Levenson
Professor
University of California, Berkeley