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Clinical Trials/NCT06631144
NCT06631144
Active, Not Recruiting
N/A

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.1 site in 1 country270 target enrollmentDecember 4, 2024

Overview

Phase
N/A
Intervention
Not specified
Conditions
Caregiver Burden
Sponsor
Ceresti Health, Inc.
Enrollment
270
Locations
1
Primary Endpoint
Longitudinal Engagement
Status
Active, Not Recruiting
Last Updated
8 months ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
December 4, 2024
End Date
February 27, 2026
Last Updated
8 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Ceresti Health, Inc.
Responsible Party
Sponsor

Eligibility Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

Longitudinal Engagement

Time Frame: 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

Time Frame: 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.

Secondary Outcomes

  • 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)

Study Sites (1)

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