Care Ecosystem: Navigating Patients and Families Through Stages of Care, Extension Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 912
- 主要终点
- Change in Quality of Life - AD (Alzheimer's Disease)
研究概览
简要总结
This is an extension trial of a prior trial (NCT02213458). Both persons with dementia (PWD) and their caregivers were enrolled as dyads. The purpose of this randomized clinical trial is to evaluate the benefits of a program that supports model care for PWD and their caregivers. Whereas the prior trial only delivered care and examined outcomes up to 12-months, this trial extends care and outcome measurement for 5 years or until death, and includes all dyads where the caregiver reported high caregiver burden (Zarit-12 greater than or equal to 17) at pre-randomization baseline for the original trial. Participants were recruited from California, Nebraska and Iowa. Participants determined to be eligible were consented and randomized into one of two groups. Two thirds of dyads were enrolled into Navigated Care that provided them with phone-based 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 dyads were enrolled to a control group, entitled Survey of Care. Outcomes were unchanged from the original trial except for the addition of time to long term care placement and are detailed below.
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
- 18 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 English, Cantonese, 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 English, Cantonese, or Spanish
- •Caregiver is a legal adult
- •Zarit-12 caregiver burden score greater than or equal to 17 at pre-randomization (baseline); this criteria is specific to this extension trial
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 the investigator's trial
- •Patient is pregnant
研究组 & 干预措施
Navigated Care
Telephone-based collaborative dementia care navigation
干预措施: Navigated Care (Behavioral)
Survey of Care
Control group that will receive usual care and undergo the same regular assessments as patients enrolled in Navigated Care
结局指标
主要结局
Change in Quality of Life - AD (Alzheimer's Disease)
时间窗: From baseline to 60 months
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 Zarit Burden Interview (short version).(From baseline to 60 months)
- Change in Health Care Utilization(From baseline to 60 months)
- Time to Long Term Care Placement(From date of baseline survey to immediately following long term care placement, assessed up to 60 months)
- Change in Caregiver Self-Efficacy: 1-5 ordinal scale(From baseline to 60 months)
- Change in Patient Health Questionnaire 9 (PhQ-9).(From baseline to 60 months)