Caring for Caregivers and People Living With Dementia Under Home-Based Primary Care
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 4
- 主要终点
- Feasibility for the Caregiver to Engage With and Complete Baseline Assessments.
研究概览
简要总结
The goal of this clinical trial is to develop a dementia care intervention for persons receiving home-based primary care (HBPC) and living with dementia (PLWD) and their caregivers, and test the feasibility of implementing the intervention in HBPC practices to ultimately improve outcomes of PLWD and their caregivers.
The main aims are to:
- Develop and refine HBPC Dementia Care Quality at Home
- Establish feasibility (primary outcome), acceptability, and fidelity of HBPC Dementia Care Quality at Home through an open-pilot trial involving two HBPC practices. Trained clinicians and staff at two HBPC practices will implement the intervention
Relevant stakeholders (caregivers of PLWD, and HBPC clinicians and staff) will participate in qualitative focus groups to provide feedback on the intervention.
详细描述
The overarching goal of this project is to develop a dementia care intervention for PLWD and their caregivers, Dementia Care Quality at Home, and test the feasibility of implementing the intervention in two HBPC practices to ultimately improve outcomes of PLWD and their caregivers.
The investigators will evaluate the feasibility, acceptability, and fidelity in implementing HBPC Dementia Care Quality at Home in two practices for persons living with dementia and their caregivers through an open pilot. Hypothesis: HBPC Dementia Care Quality at Home will meet benchmarks of feasibility, acceptability, and fidelity by the HBPC practices implementing it and by caregivers of PLWD who experience the intervention. The investigators will assess feasibility of caregivers of PLWD to engage with the intervention, the acceptability of the intervention to caregivers, and the impact of the intervention on caregiver well-being by surveying caregivers at the conclusion of the pilot. In addition, the investigators will assess feasibility, acceptability, and fidelity of the intervention in the practices.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
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
- •Caregiver participants will:
- •be adults (18 years or older)
- •have English fluency and literacy
- •live in the United States
- •live with and care for an individual with Alzheimer's Disease and Alzheimer's Disease Related Dementias (ADRD)
- •anticipate providing care for the next 6 months
- •provide an average 4 hours of supervision or direct assistance per day for the care recipient and
- •have been identified by the practice as experiencing caregiver stress.
- •Staff participants will:
- •be 18 years or older
- •have English fluency and literacy and live in the United States and
- •be part of a HBPC primary care program or closely connected to the practice.
排除标准
- •Participants under the age
- •Participants who have no English fluency and literacy and do not live in the United States.
- •For caregiver participants, not caring for and living with a patient that is part of a HBPC primary care program or closely connected to the practice.
结局指标
主要结局
Feasibility for the Caregiver to Engage With and Complete Baseline Assessments.
时间窗: Baseline
The percentage of identified caregivers who complete baseline assessments.
Feasibility for the Caregiver to Access Educational Materials and Community Resources.
时间窗: Post-intervention (6 months)
Percent of caregivers will report using 1 or more materials provided by the practice.
Feasibility for the Practice of Identifying Potential Patients/Caregivers
时间窗: Baseline
Ability of practice to generate list of their patients living with dementia using a questionnaire to the practice
Feasibility for the Practice of Assessing Eligible Patient/Caregiver Dyads.
时间窗: Baseline
Ability of practice to identify eligible patient/caregiver dyads (e.g., caregiver experiencing burden or distress).
Feasibility for the Practice to Use Baseline Assessments.
时间窗: Post-intervention (6 months)
Percent of practice personnel who conduct assessments that rate assessments as feasible to use
Feasibility for the Practice to Complete Baseline Assessments
时间窗: Post-intervention (6 months)
The percent of audited assessments that are completed.
次要结局
- Feasibility for the Practice of Recruiting Patient/Caregiver Dyads(Pre-intervention)
- Caregivers - Net Promoter Score of Intervention(Post-intervention (6 months))
- Feasibility for the Practice to Use Care Modules.(Post-intervention (6 months))
- Feasibility for the Practice to Complete Care Modules(Post Intervention (6-months))
- Feasibility for the Practice of Percent of Racial and Ethnic Minorities Recruited.(Pre-intervention (baseline))
- Patient Quality of Life(Pre-Intervention (baseline) and post-intervention (6 months))
- Heard and Understood(Post Intervention (6 months))
- Feasibility for the Practice of Clinicians to Engage With the Tele-video Case Conference.(Post-intervention (6 months))
- Acceptability of the Intervention to Caregivers to Participate in the Intervention.(Pre-intervention (baseline))
研究者
Christine S. Ritchie, MD, MPH
Professor of Medicine
Massachusetts General Hospital