A Spanish-language Caregiver-Enabled Care Program (CECP)

Ceresti Health, Inc.

Status: Active, not recruiting

Conditions: Alzheimer Disease; Caregiver Burden; Dementia Alzheimers; Caregiver; Dementia

Treatments: Behavioral: Spanish-language Caregiver-Enabled Care Program (CECP)

Study type: Interventional

Funder types: Industry; NIH

Identifiers

NCT06631144

CER-2024-111-001

1R43AG088143-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 270 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Exclusion Criteria:

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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270 participants in 1 patient group

Caregiver-Enabled Care Group

Experimental group

Description:

Caregiver participants will receive Ceresti's Caregiver-Enabled Care Program. (CECP) is a 6-month non-medical digital program that promotes the wellness of family caregivers, and increases their knowledge, skills and confidence ("activation") in caring for a loved one with dementia. CECP delivers personalized health education, access to resources, proactive coaching, personalized support, and remote monitoring via a dedicated tablet that is shipped to the caregiver's home.

Treatment:

Behavioral: Spanish-language Caregiver-Enabled Care Program (CECP)