Care Program for Dementia Caregivers

(CECP Trial)

Overseen By Nicole McPherson

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ceresti Health, Inc.

Disqualifiers: Disenrollment plans, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new digital program designed to support Spanish-speaking caregivers of people with dementia. The program, called the Spanish-language Caregiver-Enabled Care Program (CECP), provides personalized education, coaching, and remote monitoring through a tablet at no cost. It aims to enhance caregivers' confidence and skills in caring for their loved ones. Spanish-speaking caregivers supporting a family member with dementia may be well-suited for this trial. As an unphased trial, this study offers a unique opportunity to access innovative support tools specifically designed for Spanish-speaking caregivers.

Do I have to stop taking my current medications for this trial?

The trial does not specify whether you need to stop taking your current medications. It focuses on a nonmedical digital health program for caregivers, so it's unlikely that medication changes are required.

What prior data suggests that this digital health intervention is safe for caregivers?

Research has shown that the Spanish-language Caregiver-Enabled Care Program (CECP) is a digital tool that avoids drugs or medical procedures, making it generally safer. The program offers personalized education, coaching, and support through a tablet. As a digital health program, it is user-friendly and has no significant safety concerns or reported issues. The goal is to enhance caregivers' skills and confidence, not to provide medical treatment, which typically ensures a high level of safety for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional dementia care options that typically focus on the patient, the Spanish-language Caregiver-Enabled Care Program (CECP) shifts the spotlight to the caregivers themselves. This program is unique because it provides caregivers with personalized health education, proactive coaching, and remote monitoring, all delivered through a dedicated tablet. Researchers are excited about this approach because it empowers caregivers, enhancing their skills and confidence in managing their loved one's dementia, potentially leading to better outcomes for both caregivers and patients.

What evidence suggests that the Spanish-language Caregiver-Enabled Care Program (CECP) is effective for dementia caregivers?

Research has shown that the Spanish-language Caregiver-Enabled Care Program (CECP), which participants in this trial will receive, is designed to assist Spanish-speaking caregivers of people with dementia by offering personalized support and education. This program aims to enhance caregivers' knowledge, skills, and confidence in managing daily challenges. Although specific results from past studies are not available, digital tools and one-on-one coaching have improved caregiver well-being and reduced stress. The CECP provides practical support by offering resources and remote monitoring through a tablet, potentially leading to better care for loved ones with dementia and improving caregivers' quality of life. ^{1 2 3 6 7}

Who Is on the Research Team?

Dirk Soenksen

Principal Investigator

CEO

Are You a Good Fit for This Trial?

This trial is for Spanish-speaking caregivers in the U.S. who are part of a PACE or dementia support network, caring for someone with dementia. Caregivers must be adults willing to engage with a digital health program and able to read and write Spanish.

Inclusion Criteria

Caregiver's primary language is Spanish. Able to speak, read, and write Spanish

Caregiver consents to participate in the study

Patient is a participant of a Program of All-Inclusive Care for the Elderly (PACE) or dementia support network or provider in the United States

Exclusion Criteria

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in the Spanish-language Caregiver-Enabled Care Program (CECP) for 6 months, which includes personalized education, proactive coaching, and remote monitoring via a dedicated tablet.

6 months

Follow-up

Participants are monitored for engagement and outcomes such as loneliness, caregiver activation, and health status.

6 months

What Are the Treatments Tested in This Trial?

Interventions

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

Trial Overview The study tests a nonmedical digital intervention called CECP, which offers personalized education, coaching, and remote monitoring via tablet for caregivers of persons with dementia.

How Is the Trial Designed?

Group I: Caregiver-Enabled Care Group Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Ceresti Health, Inc.

Lead Sponsor

Trials

1

Recruited

270+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Published Research Related to This Trial

A scoping review identified 26 brief Spanish language cognitive screening tools, highlighting that tools like the 7-Minute Screen and Mini-Cog are more effective in classifying dementia compared to the Mini-Mental Status Examination and Montreal Cognitive Assessment.

The review emphasizes the need for nation-specific validation and normative data for these cognitive screeners, as their sensitivity and specificity can vary significantly across different countries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Utility of Cognitive Screeners in the Detection of Dementia Spectrum Disorders in Spanish-Speaking Populations. Burke, SL., Grudzien, A., Burgess, A., et al.[2023]

A Spanish language adaptation of a virtual Mentalizing Imagery Therapy (MIT) program was successfully implemented for 12 Spanish-speaking family caregivers of people with dementia, showing high satisfaction and full participation in the program.

The caregivers experienced a significant reduction in depressive symptoms by week three, which was maintained at a 4-month follow-up, along with improvements in mindfulness, caregiver burden, and overall well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual mentalizing imagery therapy for Spanish language Latino family dementia caregivers: A feasibility and acceptability study. Ramirez-Gomez, L., Johnson, JK., Ritchie, C., et al.[2023]

The El Portal Latino Alzheimer's Project effectively reduced barriers to care for Latino caregivers of dementia-affected adults in Los Angeles County, leading to increased utilization of services.

This community-based program highlights the importance of culturally sensitive outreach and coordinated services, addressing the unique needs of Latino families dealing with dementia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

El Portal Latino Alzheimer's Project: model program for Latino caregivers of Alzheimer's disease-affected people. Aranda, MP., Villa, VM., Trejo, L., et al.[2021]

A culturally tailored patient navigator intervention significantly supported Hispanic family caregivers of patients with Alzheimer's disease, helping them manage caregiving challenges and improve their awareness of available resources.

The study revealed that caregivers often face strain due to cultural expectations and lack of shared responsibilities, highlighting the importance of tailored support to enhance palliative care access for underserved populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reality of Family Caregiving for Hispanics With Alzheimer's Disease and Related Dementias: A Qualitative Analysis. Fink, RM., Valenti, KG., Kline, DM., et al.[2023]

Older primary caregivers and those with additional informal support or significant health issues are more likely to attend psychoeducational support groups, indicating that their specific needs drive participation.

Mexican American caregivers showed lower attendance in English-language groups compared to Anglo American caregivers, but their attendance in Spanish-language groups was comparable, highlighting the importance of language and cultural relevance in caregiver support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Caregiver support groups: factors affecting use of services. Monahan, DJ., Greene, VL., Coleman, PD.[2021]

A new website, Cuidatecuidador.com, was created to provide bilingual information specifically for Spanish-speaking caregivers of individuals with dementia, addressing a significant gap in culturally appropriate resources.

Evaluation of the website by caregivers from three countries indicated that access to this information may lead to increased feelings of mastery and a decrease in depressive symptoms among caregivers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of an online community to provide support to caregivers of people with dementia. Pagán-Ortiz, ME., Cortés, DE., Rudloff, N., et al.[2022]

Latino dementia caregivers often experience limited family support, which is linked to higher risks of burnout and distress, with many caregivers reporting that neuropsychiatric symptoms of dementia hinder family unity.

Caregivers with extensive support benefit from larger family sizes and shared caregiving responsibilities, highlighting the need for culturally competent interventions that enhance communication and problem-solving skills among family members.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characteristics and Consequences of Family Support in Latino Dementia Care. Rote, S., Angel, J., Hinton, L.[2023]

The Savvy Caregiver Program significantly improved caregiver competence and reduced depression among English-speaking caregivers from Hispanic, Black/African American, and Asian/Pacific Islander backgrounds over a 12-month period.

Caregivers reported better management of their situations and increased tolerance for their care recipients' memory problems, demonstrating that the program is effective across diverse ethnic groups, similar to its impact on Caucasian caregivers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Savvy Caregiver Program: impact of an evidence-based intervention on the well-being of ethnically diverse caregivers. Kally, Z., Cote, SD., Gonzalez, J., et al.[2021]

The cultural adaptation of the Adult Day Service Plus intervention for Hispanic/Latino caregivers is crucial, as it goes beyond mere translation to incorporate cultural nuances and care preferences, enhancing the intervention's relevance and effectiveness.

Incorporating cultural elements into supportive care interventions can improve participation and outcomes for Hispanic/Latino caregivers and their families, ensuring that evidence-based programs are equitably accessible and effective.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

It's More Than Language: Cultural Adaptation of a Proven Dementia Care Intervention for Hispanic/Latino Caregivers. Parker, LJ., Marx, KA., Nkimbeng, M., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06631144

A Spanish-language Caregiver-Enabled Care Program The purpose of the study is to develop and test the feasibility of a nonmedical digital health intervention, the Spanish-language Caregiver-Enabled Care ...

2. reporter.nih.gov reporter.nih.gov/project-details/10923735

Improving health equities for Hispanic/Latino families living ... Improving health equities for Hispanic/Latino families living with dementia by validating a Spanish-language Caregiver-Enabled Care Program (CECP) in PACE ...

3. sbir.gov sbir.gov/awards/213384

Award | SBIR Improving health equities for Hispanic/Latino families living with dementia by validating a Spanish-language Caregiver-Enabled Care Program (CECP) in PACE ...

4. reporter.nih.gov reporter.nih.gov/search/14E9CE024F8FC5D27598B8961CAA4A01A2FFCEB861BF/project-details/10923735

Improving health equities for Hispanic/Latino ... - NIH RePORTER Project Narrative Hispanics/Latinos are projected to experience the largest increase in dementia prevalence of any ethnic group, with an 832% growth from ...

5. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06631144/a-spanish-language-caregiver-enabled-care-program

A Spanish-language Caregiver-Enabled Care Program The purpose of the study is to develop and test the feasibility of a nonmedical digital health intervention, the Spanish-language ...

6. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/2829720

Health System, Community-Based, or Usual Dementia ... In this randomized clinical trial of dementia care programs, there were no significant differences between a health system–based vs a community-based care ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT06631144?term=alzheimer

A Spanish-language Caregiver-Enabled Care Program The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure.