Drexel University, 1601 Cherry Street, 10th Floor, Room 1092, Philadelphia, PA 19102, United States of America.
Johns Hopkins School of Nursing, Center for Innovative Care in Aging, 901 N. Broadway, Room 214, Baltimore, MD 21205, United States of America.
Contemp Clin Trials. 2019 Aug;83:97-108. doi: 10.1016/j.cct.2019.06.010. Epub 2019 Jun 22.
There are over five million people in the United States living with dementia. Most live at home and are cared for by family. These family caregivers often assume care responsibilities without education about the disease, skills training, or support, and in turn become at risk for depression, burden, and adverse health outcomes when compared to non-dementia caregivers. Despite over 200 caregiver interventions with proven benefits, many caregivers lack access to these programs. One approach to enhance access is to embed evidence-based caregiver support programs in existing community-based services for people with dementia such as adult day services (ADS). Here we describe the protocol for an embedded pragmatic trial designed to augment standard ADS known as ADS Plus. ADS Plus provides family caregivers with support via education, referrals, and problem-solving techniques over 12 months, and is delivered on-site by existing ADS staff. Embedding a program in ADS requires an understanding of outcomes and implementation processes in that specific context. Thus, we deploy a hybrid design involving a cluster randomized two-group trial to evaluate treatment effects on caregiver wellbeing, ADS utilization, as well as nursing home placement. We describe implementation practices in 30 to 50 geographically and racially/ethnically diverse participating sites. Clinical trial registration #: NCT02927821.
美国有超过 500 万人患有痴呆症。大多数人住在家里,由家人照顾。这些家庭照顾者通常在没有疾病知识、技能培训或支持的情况下承担照顾责任,与非痴呆症照顾者相比,他们更容易患上抑郁症、负担过重和出现健康不良后果。尽管有 200 多项经过验证的 caregiver 干预措施,但许多 caregiver 无法获得这些方案。一种增加获得途径的方法是将基于证据的 caregiver 支持计划嵌入到现有的针对痴呆症患者的社区服务中,例如成人日间服务 (ADS)。在这里,我们描述了一项嵌入式实用试验的方案,旨在增强称为 ADS Plus 的标准 ADS。ADS Plus 通过教育、转介和解决问题的技巧在 12 个月内为家庭照顾者提供支持,并由现有的 ADS 工作人员在现场提供。在 ADS 中嵌入一个项目需要了解该特定环境中的结果和实施过程。因此,我们采用了一种混合设计,包括一项两群组的集群随机试验,以评估治疗对照顾者健康、ADS 使用情况以及疗养院安置的影响。我们描述了在 30 到 50 个具有地理和种族/民族多样性的参与地点的实施实践。临床试验注册号:NCT02927821。