Viewing Study NCT06631144



Ignite Creation Date: 2024-10-26 @ 3:42 PM
Last Modification Date: 2024-10-26 @ 3:42 PM
Study NCT ID: NCT06631144
Status: NOT_YET_RECRUITING
Last Update Posted: None
First Post: 2024-08-27

Brief Title: A Spanish-language Caregiver-Enabled Care Program
Sponsor: None
Organization: None

Study Overview

Official Title: Improving Health Equities for HispanicLatino Families Living With Dementia by Validating a Spanish-language Caregiver-Enabled Care Program CECP in PACE Participants
Status: NOT_YET_RECRUITING
Status Verified Date: 2024-10
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: No
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: CECP
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 11 human coaching and remote monitoring all delivered via a dedicated tablet shipped to the caregivers home at no cost to the caregiver or PWD For this study the investigators are recruiting 135 patientcaregiver dyads
Detailed Description: For HispanicLatino families in the United States US 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 HispanicLatino families in the US To address health disparities in dementia care for HispanicLatino families in the US 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 caregiverdementia-patient dyads living in the US 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None