Primary Care-based Pilot ePCT of an Online Workshop for Family Caregivers of PLWD
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 109
- 试验地点
- 2
- 主要终点
- 3a. Percent of Enrolled Caregivers Who Complete Caregiver Depressive Symptoms (PHQ-8) Survey Questions
研究概览
简要总结
Many family and friend caregivers of persons living with dementia experience depression, stress, and other adverse health consequences due to the responsibilities of their caregiving role. These caregivers express a desire for education and support. The overarching goal of this project is to improve education and support for caregivers of persons living with dementia so that they can take better care of themselves and also their person living with dementia.
Building Better Caregivers workshop is an online, 6-week, small group workshop for family caregivers of persons living with dementia that teaches them caregiving skills and how to manage difficult emotions, stress, and other challenging aspects of caregiving. Caregivers also receive support from other caregivers and two trained workshop facilitators and a workbook to keep. The workshop uses asynchronous delivery that allows caregivers to use materials at home when they have time day or night, self-pace their learning, and chat with other caregivers through threaded discussion board conversations.
In this pilot embedded pragmatic clinical trial the investigators will evaluate the workshop among 108 caregivers who receive health care in urban areas of California and rural areas of New York. To achieve the project goals the investigators will (1) determine the feasibility of identifying, enrolling, and randomizing caregivers to a workshop group or wait-list group; (2) assess the feasibility of using electronic health record data as study outcomes, including depressive symptoms of caregivers and emergency room visits and hospitalizations of their patients with dementia; and (3) determine whether caregivers complete the workshop and think it is acceptable.
If this pilot trial is successful, the investigators will have the information necessary to conduct a larger study among many additional caregivers with the long-term goal of improving their health and the well-being of their person with dementia.
详细描述
The overarching goal of this project is to improve education and support for family caregivers of persons living with dementia so that they can take better care of themselves and also their person living with dementia.
Objectives
The goals of this project are to perform a pilot embedded pragmatic clinical trial (ePCT) of the Building Better Caregivers (BBC) workshop among 108 family caregivers of persons living with dementia (PLWD) receiving care at the University of California San Francisco (UCSF) or Bassett Healthcare Network (Bassett) of New York and, in doing so, pilot test all clinical trial components necessary to the success of a future larger trial. To accomplish these goals, investigators will:
- Evaluate the feasibility of using pragmatic methods to identify, enroll, and randomize caregivers (N=108) of PLWD who receive healthcare at UCSF or Bassett Healthcare Network to intervention (BBC workshop) or wait-list control group.
- Determine the feasibility, acceptability, and fidelity of implementing the online 6-week workshop in USCF and Bassett primary care clinics.
- Assess the feasibility of using pragmatic methods for clinical outcomes ascertainment including caregiver depressive symptoms (primary clinical outcome, collected through usual clinical care approaches) and ER visits and hospitalizations of PLWD (secondary outcomes)
Trial design
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
盲法说明
Principal investigator and biostatistician
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
- •Age: 18 years and older (no upper limit)
- •Sex/Gender: any sex, any gender
- •Race/ethnicity: any race/ethnicity
- •Able to read and write in English
- •Have internet access on any device (computer, tablet, smartphone) but does not require high speed internet
- •Provide care to a person living with dementia who is a primary care patient participating health system, i.e., UCSF or Bassett
- •Receive own healthcare at participating health system, i.e., UCSF or Bassett
排除标准
- •- Investigator discretion for clinical safety or protocol adherence reasons, e.g., potential participant who might not be able to meet the time requirements of the study (anticipating a move)
研究组 & 干预措施
Workshop
A 6-week, online, peer-led small group workshop designed for family caregivers of persons living with dementia.
干预措施: Building Better Caregivers workshop (Behavioral)
Control
Wait-list control group.
结局指标
主要结局
3a. Percent of Enrolled Caregivers Who Complete Caregiver Depressive Symptoms (PHQ-8) Survey Questions
时间窗: Up to 4 months
Percentage of enrolled caregivers who complete caregiver depressive symptoms survey questions from the 8-item Patient Health Questionnaire (PHQ-8), with score range 0-24 (higher score indicates worse depressive symptoms), with range 0% to 100% (higher percentage indicates higher completion rate).
次要结局
- 3b. Healthcare Utilization of Emergency Room Visits and Hospitalizations by Person Living With Dementia(Up to 5.5 months)