University of California, San Francisco (UCSF) and University of Nebraska Medical Center (UNMC) Care Ecosystem
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,560
- 试验地点
- 2
- 主要终点
- Quality of Life-Alzheimer's Disease, Change From Baseline to 1 Year
研究概览
简要总结
This is a randomized clinical trial evaluating the benefits of a program that supports model care for persons with dementia and their family caregivers. Subjects were recruited from California, Nebraska and Iowa. Subjects determined to be eligible were consented and randomized into one of two groups. Two thirds of patients were enrolled into Navigated Care that provided them with assistance in meeting important benchmarks in their care, for example completion of legal and financial planning and strategies for minimizing caregiver burden. One third of patients were enrolled to a control group, entitled Survey of Care. Outcomes include quality of life, health care utilization, caregiver burden, satisfaction with care, caregiver depression, and caregiver self-efficacy.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •This study will enroll patients as well as their primary caregivers as research participants.
- •Inclusion criteria for patient participants:
- •Patient has a diagnosis of dementia with a progressive course
- •Patient has a primary caregiver (identified as having primary responsibility for patient) that is eligible for and agrees to join the study
- •Patient is covered by Medicare or Medi-caid or is Medi-pending
- •Patient is expected to live at least 3 months based on assessment by the referring provider, the patient's primary care provider, or medical record review
- •Patient speaks either English, Cantonese, Mandarin, or Spanish
- •Patient lives in California or Nebraska or Iowa
- •Patient is age 45 or older
- •Inclusion criteria for caregiver participants:
- •Caregiver has primary responsibility for dementia patient that is eligible for and agrees to join the study
- •Caregiver speaks either English, Cantonese, Mandarin, or Spanish
- •Caregiver is a legal adult
排除标准
- •Patient resides in a nursing home or skilled nursing facility at time of enrollment
- •Participant is enrolled in a similar clinical trial that precludes their participation in our trial
- •Patient is pregnant
研究组 & 干预措施
Navigated Care
Comprehensive longitudinal continuing care program
干预措施: Navigated Care (Behavioral)
Survey of Care
Control group that will undergo the same regular assessments as patients enrolled in Navigated Care
结局指标
主要结局
Quality of Life-Alzheimer's Disease, Change From Baseline to 1 Year
时间窗: Baseline to one year
An established 13-item measure, with a 1-4 ordinal scale for each item, to obtain a rating of the patient's quality of life from the caregiver. Item scores are summed for a total score ranging from 13-52, with higher scores representing better quality of life
次要结局
- Change in Caregiver Self-efficacy, Baseline to One Year(Baseline to one year)
- Change in Caregiver Depression, Baseline to One Year(Baseline to one year)
- Satisfaction With Dementia Care(One year)
- Change in Caregiver Reported Rate of Emergency Department Utilization: Baseline to One Year(Baseline to one year)
- Change in Caregiver Burden, Baseline to One Year(Baseline to one year)