跳至主要内容
临床试验/NCT07346183
NCT07346183尚未招募不适用

CommunityRx-Dementia + Peer Navigation (CRxDpeer): A Real-World Implementation and Effectiveness Study of an IT-Based Social Care Intervention

University of Chicago0 个研究点目标入组 330 人开始时间: 2026年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
330
主要终点
Caregiver loneliness at 6 months

研究概览

简要总结

The CRxDpeer intervention, delivered by a trained peer navigator, in practice called a "peer mentor", includes three evidence-based components: (a) focused education about common social (e.g., food and housing insecurity) and caregiving (e.g., respite and end of life care) needs, (b) activation of personalized community resource information for social and caregiving needs through delivery of a resource list (HealtheRx) at the baseline encounter and coaching on how to communicate with service providers, coordinate services and manage social support (e.g., connect with their peer navigator, reach out to friends or relatives for support, identify support groups, etc.) and (c) ongoing navigation-focused support meant to boost the baseline intervention, including a series of proactive text messages over 12 months. During this time, the subject can respond to and communicate with the peer navigator for ongoing support.

详细描述

In 2022, more than 11 million Americans, half of whom were 50 or older, provided more than 18 billion hours of unpaid care for people with dementia. Many caregivers have no formal training and limited support. The White House, along with the Alzheimer's Association, the National Institute on Aging and others, is calling for urgent attention to the health and well-being of the fast-growing population of dementia caregivers, with heightened concern for caregivers living in historically marginalized communities. Scalable, evidence-based, solutions leveraging existing assets are urgently needed to meaningfully reach all caregivers. Our approach to addressing these unmet needs, CommunityRxDpeer, is an information technology-based, low-intensity, health system-initiated community resource navigation intervention delivered to caregivers by peer caregiver navigators remotely over time. Essential components include education about common social, including caregiving needs, activation of personalized community resource information and ongoing navigation-focused support. The CRxDpeer intervention components are informed by evidence-based "processes" identified in the Grey et al. Self- and Family Management Framework that are known to promote desirable health outcomes among people living or caring for others with chronic health conditions, including dementia. Prior CommunityRx trials have successfully deployed community members, clinicians and researchers to deliver the intervention in real-world and research settings with positive outcomes in a wide-range of populations. In this pragmatic trial, experienced and willing dementia caregivers from the CRxDementia cohort (2020-24) will be recruited and trained as peer navigators to deliver CRxDpeer. Using a hybrid effectiveness implementation design with a double-blind RCT, we will evaluate the effectiveness of CRxDpeer versus usual care on caregiver health and well-being, healthcare utilization and social care outcomes. In parallel, we will evaluate the adoption, fidelity and cost of CRxDpeer and, using mixed methods, characterize perceived mechanisms of impact on caregivers delivering and receiving CRxDpeer. The specific objectives are to demonstrate that CRxDpeer can be delivered in the real world with fidelity and to assess the effectiveness of this approach on important outcomes. Resource referral and peer support IT platforms deployed for intervention delivery are already in commercial use, paving a viable path to replication and scale as a stand-alone or adjunct to other caregiver interventions, like the Center for Medicare & Medicaid Guiding an Improved Dementia Experience (GUIDE) Model test, which aims to enable people with dementia to age at home by supporting family caregivers with education and resources. CRxDpeer has the potential to improve the health and well-being of millions of dementia caregivers and their care recipients by meaningfully connecting them to vital social and caregiving resources and creating opportunity for willing and experienced caregivers to support with others.

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
Double (Participant, Outcomes Assessor)

盲法说明

Double-Blind randomized controlled trial where the data collectors are blinded to the condition to which the subject has been assigned. The subject is also blinded to the condition they are assigned.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Self-identifies as a caregiver of a home-dwelling person with Alzheimer's disease or related dementias (ADRD)
  • Resides in the target geographic region of the study
  • Has access to a cell phone and agrees to receive text messages from the study
  • Has an email address that they can receive emails from
  • Individuals under the age of 18 who are emancipated minors in the state of Illinois and a caregiver of a person with dementia

排除标准

  • Minors who are not emancipated in the state of Illinois.
  • Previously participated in the intervention arm of the CommunityRx-Dementia clinical trial

研究组 & 干预措施

Cases

Experimental

Usual care + CommunityRx-Dpeer

干预措施: CommunityRx-Dpeer (Other)

Control

No Intervention

Usual Standard Care

结局指标

主要结局

Caregiver loneliness at 6 months

时间窗: 6 months

Loneliness is measured using the 3-item UCLA Loneliness Scale (Hughes et al. 2004). Responses to each of the items are scored 1= "Hardly ever", 2= "Some of the time", or 3= "Often". A total score is generated by summing the individual items, with a possible range of 3-9 and higher scores = greater loneliness.

Caregiver's self-efficacy for finding end of life/advance care planning resources for the person with dementia at 12 months

时间窗: 12 months

Self-efficacy is measured using a single item question developed for this study: "How confident are you that you can find resources to help \[name of care recipient\] put into writing their medical wishes if they were very sick or near the end of their life?". Responses are measured on a 4-point scale of 1="Not at all confident", 2="Not very confident", 3="Somewhat confident", or 4="Completely confident" \[higher score = greater self-efficacy\].

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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