Comparative Effectiveness of the NYU Caregiver Intervention in Latinos in Northern Manhattan
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 139
- 试验地点
- 1
- 主要终点
- Change in Caregiver Depressive Symptoms
研究概览
简要总结
Elderly Hispanics have a higher burden of dementia compared to Non-Hispanic Whites. Furthermore, Hispanic caregivers tend to have a higher burden of care for their relatives with dementia. The objective of this project is to conduct a randomized trial in 160 Hispanic relative caregivers of persons with dementia comparing the effectiveness of New York University Caregiver Intervention to a case management intervention lead by community health workers(CHW). This trial will last 6 months. The main outcomes in the trial will be changes in depressive symptoms measured with the Geriatric Depression Scale and caregiver burden measured with the Zarit Caregiver Burden Scale. This research project will be conducted by the Northern Manhattan Center of Excellence in Comparative Effectiveness Research for Eliminating Disparities (NOCERED) funded by the National Institute on Minority Health and Health Disparities.
详细描述
The goal of this study is to compare the effectiveness of an existing evidence-based dementia family caregiver intervention, the New York University Caregiver Intervention (NYUCI), to community-based case management using community health workers (CHWs) in Hispanic caregivers in Northern Manhattan. The investigators will randomize 160 relative caregivers of persons with dementia to case management alone or NYUCI in addition to case management. The total duration of followup will be 6 months. We will call this project the Northern Manhattan Caregiver Intervention Project (NOCIP).
The primary aim is to compare changes from baseline to 6 months in caregiver depressive symptoms, measured with the geriatric depression scale (GDS), and in caregiver burden using the Zarit caregiver burden interview (ZBI), between the randomization arms using an Intent to treat approach. The investigators hypothesize that depressive symptoms and caregiver burden will improve or deteriorate less in the NYUCI arm compared to the case management arm at 6 months.
This project addresses one of the priority areas for comparative effectiveness research (CER) from the Institute of Medicine, "interventions for caregivers of persons with dementia". It also addresses 2 priority conditions from the Agency for Health Care Research and Quality (AHRQ): Dementia and Depression. Dementia caregiver burden is a major source of disparities in Northern Manhattan. The prevalence of dementia in Hispanics is twice that of Non-Hispanic Whites. In addition, Hispanic families tend to be reluctant to delegate the care of their relatives with dementia and consider it a family affair. Thus, the burden of care-giving for persons with dementia is much higher in Hispanic families. NOCIP will be the first study to test the effectiveness of an existing caregiver intervention, the New York University Caregiver Intervention, in the Hispanic community of Northern Manhattan. In addition, the NYUCI has been tested in spouse caregivers, and NOCIP will be the first randomized clinical trial to include non-spouse caregivers.
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
- 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
- •Must be caring for a relative with a clinical diagnosis of dementia and have the primary responsibility for their care. All people with dementia must be living at home with their caregiver when they enroll in the study.
- •In each family, the person with dementia or the caregiver has to have at least one relative living in the New York City metropolitan area.
- •The caregiver must be emotionally and physically capable of participating. Caregivers with clinical depression or other serious mental illness will be referred.
排除标准
- 未提供
研究组 & 干预措施
NYUCI
New York University Caregiver Intervention (NYUCI) in addition to community-based case management using community health workers: The first component consists of two individual and four family counseling sessions that include relatives suggested by the caregiver.
干预措施: New York University Caregiver Intervention (NYUCI) (Behavioral)
CHW Intervention
Community-based case management using community health workers (CHWs): The CHW intervention will consist of 2 visits in month 1, followed by monthly visits until month 6.
干预措施: Community Health Worker (CHW) Case Management (Other)
结局指标
主要结局
Change in Caregiver Depressive Symptoms
时间窗: Up to 6 months from study completion
Measured with the geriatric depression scale (GDS)
次要结局
- Change in Caregiver Burden(Up to 6 months from study completion)
研究者
José A. Luchsinger
Associate Professor of Medicine and Epidemiology
Columbia University