跳至主要内容
临床试验/NCT06631144
NCT06631144进行中(未招募)不适用

Improving Health Equities for Hispanic/Latino Families Living With Dementia by Validating a Spanish-language Caregiver-Enabled Care Program (CECP) in PACE Participants

Ceresti Health, Inc.2 个研究点 分布在 1 个国家目标入组 270 人开始时间: 2024年12月4日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
270
试验地点
2
主要终点
Longitudinal Engagement

研究概览

简要总结

The purpose of the study is to develop and test the feasibility of a nonmedical digital health intervention, the Spanish-language Caregiver-Enabled Care Program (CECP), with Spanish-speaking caregivers of persons with dementia (PWD). CECP is a nonmedical digital population health intervention that provides personalized education, proactive 1:1 human coaching, and remote monitoring, all delivered via a dedicated tablet shipped to the caregiver's home at no cost to the caregiver or PWD. For this study, the investigators are recruiting 135 patient/caregiver dyads.

详细描述

For Hispanic/Latino families in the United States (U.S.), care for a loved one with dementia is provided largely by family caregivers. Evidence-based resources that support and engage family caregivers are critical to improving care and outcomes for persons living with dementia and improving the wellness of their family caregiver. However, access to these vital resources is limited for Hispanic/Latino families in the U.S. To address health disparities in dementia care for Hispanic/Latino families in the U.S., the investigators are developing an approach for deploying the proven Caregiver-Enabled Care Program (CECP) to Spanish-speaking caregivers of patients with dementia. For this study, the investigators will enroll 135 Spanish-speaking family caregiver/dementia-patient dyads living in the U.S. who are participants in a Program for All-Inclusive Care for the Elderly (PACE) or dementia support network or provider. Participation for each caregiver enrolled in the study involves engaging in the Spanish-language CECP for 6 months. The overall duration of the research project is 12 months.

At the conclusion of the study, the investigators expect to show that the highly- scalable approach using Artificial Intelligence (AI) plus human validation provides a Spanish-language CECP that can achieve comparable engagement of the proven English-language CECP. The investigators will measure differences in how Spanish-speaking caregivers engage in education, coaching, and assessments compared to the engagement of English-speaking caregivers. Understanding these differences will allow the investigators to explore potential cultural differences in user engagement and inform future optimization of the program. This Phase 1 Small Business Innovation Research (SBIR) study is supported by the National Institute On Aging (NIA) of the National Institutes of Health (NIH) under Award Number R43AG088143.

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

入选标准

  • Patient/Caregiver Dyad Inclusion Criteria
  • Patient Inclusion Criteria:
  • Is a participant of a Program of All-Inclusive Care for the Elderly (PACE) or dementia support network or provider in the United States
  • Identifies as Hispanic/Latino
  • Has a Spanish-speaking familial caregiver (spouse, adult child, other family member, or friend) that is willing and able to participate in all aspects of this study
  • Has a diagnosis of dementia
  • Consents to participate in study, or has an Authorized Representative that consents
  • Caregiver Inclusion Criteria:
  • Is a Spanish-speaking family caregiver (spouse, adult child, other family member, friend) providing care/support for the person with dementia
  • Is an adult aged 18 or older
  • Primary language is Spanish. Able to speak, read, and write Spanish
  • Consents to participate in the study

排除标准

  • Patient plans to disenroll from the PACE program or dementia support network or provider in in less than 6 months

结局指标

主要结局

Longitudinal Engagement

时间窗: From the date of enrollment in the program until the last assessment, assessed up to 6 months.

Longitudinal Engagement for this study is assessed as the month-to-month continuation rate of Spanish-speaking caregivers enrolled in the CECP.

Intensity of Engagement

时间窗: From the date of enrollment in the program until the last assessment, assessed up to 6 months.

Intensity of Engagement for this study is assessed as the average weekly engagement time of enrolled Spanish-speaking caregivers in education, coaching and assessment of the CECP.

次要结局

  • Centers for Disease Control and Prevention (CDC) Healthy Days Measure (Spanish version)(From the date of enrollment until the last monthly assessment, assessed every month up to 6 months)
  • Caregiver Activation Scale (in Spanish)(From the date of enrollment until the last monthly assessment, assessed every month up to 6 months)
  • Loneliness Scale (in Spanish)(From From the date of enrollment until the last monthly assessment, assessed every month up to 6 months)

研究者

发起方
Ceresti Health, Inc.
申办方类型
Industry
责任方
Sponsor

研究点 (2)

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