A Spanish-language Caregiver-Enabled Care Program

NCT06631144 | Active Not Recruiting

• 2 other identifiers: CER-2024-111-0011R43AG088143-01
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 1

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.

Conditions

Dementia; Dementia Alzheimers; Alzheimer Disease; Caregiver; Caregiver Burden

Keywords

Digital Health Intervention; Spanish

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• 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 Arms (1)

Caregiver-Enabled Care Group

EXPERIMENTAL

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)

Interventions

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

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.

Caregiver-Enabled Care Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

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

Sponsors & Collaborators

• Ceresti Health, Inc.: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Ceresti Health

Carlsbad, California, 92010, United States

Location

MeSH Terms

Conditions

Dementia; Alzheimer Disease; Caregiver Burden

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Tauopathies; Neurodegenerative Diseases; Stress, Psychological; Behavioral Symptoms; Behavior

Study Officials

• Dirk Soenksen

  CEO

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A single-arm feasibility study to test a non-medical digital health intervention

Study Record Dates

• First Submitted: August 27, 2024
• First Posted: October 8, 2024
• Study Start: December 4, 2024
• Primary Completion: January 22, 2026
• Study Completion: February 27, 2026
• Last Updated: August 12, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)