Clinical trial NCT06631144: A Spanish-language Caregiver-Enabled Care Program
Official title: Improving Health Equities for Hispanic/Latino Families Living With Dementia by Validating a Spanish-language Caregiver-Enabled Care Program (CECP) in PACE Participants
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dementia
Dementia Alzheimers
Alzheimer Disease
Caregiver
Caregiver Burden
Keywords: Digital Health Intervention
Spanish
Lead sponsor: Ceresti Health, Inc.
Sponsor class: INDUSTRY
Collaborators: name: National Institute on Aging (NIA)
First posted: 2024-10-08
Enrollment: 270
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A single-arm feasibility study to test a non-medical digital health intervention
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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

Primary outcomes:
measure: Longitudinal Engagement
timeFrame: From the date of enrollment in the program until the last assessment, assessed up to 6 months.
measure: Intensity of Engagement
timeFrame: From the date of enrollment in the program until the last assessment, assessed up to 6 months.
Secondary outcomes:
measure: Centers for Disease Control and Prevention (CDC) Healthy Days Measure (Spanish version)
timeFrame: From the date of enrollment until the last monthly assessment, assessed every month up to 6 months
measure: Caregiver Activation Scale (in Spanish)
timeFrame: From the date of enrollment until the last monthly assessment, assessed every month up to 6 months
measure: Loneliness Scale (in Spanish)
timeFrame: From From the date of enrollment until the last monthly assessment, assessed every month up to 6 months
Other outcomes:
Locations:
city: Carlsbad
country: United States
facility: Ceresti Health
state: California
Study officials:
affiliation: CEO
name: Dirk Soenksen
role: PRINCIPAL_INVESTIGATOR
References: