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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Dementia; Alzheimer Disease; Caregiver Burden; Dementia Alzheimers; Caregiver
• Intervention / Treatment: Behavioral: Spanish-language Caregiver-Enabled Care Program (CECP)

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.

• Study Type: Interventional
• Enrollment (Actual): 270
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Carlsbad, California, United States, 92010
      • Ceresti Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Caregiver-Enabled Care Group; 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.

Behavioral: Spanish-language Caregiver-Enabled Care Program (CECP); CECP is a nonmedical digital population health intervention to support and engage family caregivers of persons with dementia. CECP consists of digital content, including health education videos and tutorials, that is delivered to caregivers on a dedicated tablet based on their specific needs. Caregivers are supported by a proactive human coach who provides support, access to resources, and performs risk mitigation measures as necessary. Alerts are shared with providers and/or care management teams via a data hub that makes it easy to track, manage and resolve alerts. CECP is delivered over a 6-month period via a dedicated tablet that is shipped to the caregiver's home at no cost to the caregiver or person with dementia. This study's CECP is in Spanish.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Longitudinal Engagement	Longitudinal Engagement for this study is assessed as the month-to-month continuation rate of Spanish-speaking caregivers enrolled in the CECP.	From the date of enrollment in the program until the last assessment, assessed up to 6 months.
Intensity of Engagement	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.	From the date of enrollment in the program until the last assessment, assessed up to 6 months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Centers for Disease Control and Prevention (CDC) Healthy Days Measure (Spanish version)	Centers for Disease Control and Prevention (CDC) Healthy Days Measure evaluates participants' health status over the past 30 days. For most questions, 0 days indicates the best health status, and 30 days indicates the worst health status. Higher scores on the Centers for Disease Control and Prevention (CDC) Healthy Days Measure generally indicate worse outcome, reflecting more days of poor physical and mental health. Additionally, participants identify their major health problem, indicate whether it limits daily living, and specify the level of assistance needed for personal care and routine activities by selecting one response from a provided list.	From the date of enrollment until the last monthly assessment, assessed every month up to 6 months
Caregiver Activation Scale (in Spanish)	Custom question developed by Ceresti to measure increase in caregiver knowledge, skills and confidence. Higher scores on the Caregiver Activation Scale indicate better outcome.	From the date of enrollment until the last monthly assessment, assessed every month up to 6 months
Loneliness Scale (in Spanish)	Custom questions developed by Ceresti to measure feelings of loneliness experienced in the past 30 days. Higher scores on the Loneliness Scale indicate worse outcome.	From From the date of enrollment until the last monthly assessment, assessed every month up to 6 months

Collaborators and Investigators

• Sponsor: Ceresti Health, Inc.
• Collaborators: National Institute on Aging (NIA)
• Investigators: Principal Investigator: Dirk Soenksen, CEO

Study record dates

Study Major Dates

• Study Start (Actual): December 4, 2024
• Primary Completion (Estimated): January 22, 2026
• Study Completion (Estimated): February 27, 2026

Study Registration Dates

• First Submitted: August 27, 2024
• First Submitted That Met QC Criteria: October 4, 2024
• First Posted (Actual): October 8, 2024

Study Record Updates

• Last Update Posted (Actual): August 12, 2025
• Last Update Submitted That Met QC Criteria: August 11, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Spanish; Digital Health Intervention
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Behavioral Symptoms; Neurocognitive Disorders; Tauopathies; Neurodegenerative Diseases; Stress, Psychological; Caregiver Burden; Alzheimer Disease; Dementia
• Other Study ID Numbers: CER-2024-111-001; 1R43AG088143-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: De-identified, aggregated, summarized data will be made available for sharing.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No