DementiaCECPNCT06631144
A Spanish-language Caregiver-Enabled Care Program
A study testing Spanish-language Caregiver-Enabled Care Program (CECP) in people with Dementia and Dementia Alzheimers, run by Ceresti Health, Inc. at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dementia, Dementia Alzheimers, Alzheimer Disease
- What is being tested?
- Spanish-language Caregiver-Enabled Care Program (CECP)
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Dec 2024to 27 Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Patient plans to disenroll from the PACE program or dementia support network or provider in in less than 6 months
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Dementia, Dementia Alzheimers, Alzheimer Disease, Caregiver, Caregiver Burden
- Being tested
- Spanish-language Caregiver-Enabled Care Program (CECP)
- Keywords
- Digital Health Intervention, Spanish
- Medical subject headings
- Dementia, Alzheimer Disease, Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spanish-language Caregiver-Enabled Care Program (CECP)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Spanish-language Caregiver-Enabled Care Program (CECP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Longitudinal Engagement
Longitudinal Engagement for this study is assessed as the month-to-month continuation rate of Spanish-speaking caregivers enrolled in the CECP.
Measured: 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.
Measured: 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)
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.
Measured: 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.
Measured: 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.
Measured: From From the date of enrollment until the last monthly assessment, assessed every month up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2024
- Study start4 Dec 2024
- Primary completion22 Jan 2026 (estimated)
- Study completion27 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A single-arm feasibility study to test a non-medical digital health intervention
- Masking
- None (open label)
- Enrolment
- 270 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ceresti Health, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Dirk Soenksen, Principal investigator, CEO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06631144
- Sponsor's protocol ID
- CER-2024-111-001
- Other IDs
- 1R43AG088143-01
- Acronym
- CECP
- Status last verified
- Aug 2025
- First submitted
- 27 Aug 2024
- Last updated
- 12 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: De-identified, aggregated, summarized data will be made available for sharing.
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06631144
- Acronym / sponsor ID
- CECP / CER-2024-111-001
- Conditions
- Dementia, Dementia Alzheimers, Alzheimer Disease, Caregiver, Caregiver Burden
- Keywords
- Digital Health Intervention, Spanish
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 270 participants (actual)
- Lead sponsor
- Ceresti Health, Inc.Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 4 Dec 2024 (actual)
- Primary completion
- 22 Jan 2026 (estimated)
- Study completion
- 27 Feb 2026 (estimated)
- First posted
- 8 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A single-arm feasibility study to test a non-medical digital health intervention
| Arm | Type | Receives |
|---|---|---|
| Caregiver-Enabled Care Group | Experimental | Behavioral: Spanish-language Caregiver-Enabled Care Program (CECP)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 may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- Patient plans to disenroll from the PACE program or dementia support network or provider in in less than 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Caregiver-Enabled Care Group |
Primary outcome
Longitudinal Engagement
Time frame: From the date of enrollment in the program until the last assessment, assessed up to 6 months.
Longitudinal Engagement for this study is assessed as the month-to-month continuation rate of Spanish-speaking caregivers enrolled in the CECP.
Intensity of Engagement
Time frame: From the date of enrollment in the program until the last assessment, assessed up to 6 months.
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.
3 secondary outcomes
Centers for Disease Control and Prevention (CDC) Healthy Days Measure (Spanish version)
Time frame: From the date of enrollment until the last monthly assessment, assessed every month up to 6 months
Caregiver Activation Scale (in Spanish)
Time frame: From the date of enrollment until the last monthly assessment, assessed every month up to 6 months
Loneliness Scale (in Spanish)
Time frame: From From the date of enrollment until the last monthly assessment, assessed every month up to 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2025.
- Individual participant dataSharing planned: No. De-identified, aggregated, summarized data will be made available for sharing.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dirk Soenksen principal investigator
CEO
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spanish-language Caregiver-Enabled Care Program (CECP) in people with Dementia and Dementia Alzheimers, run by Ceresti Health, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 12 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Longitudinal Engagement (time frame: From the date of enrollment in the program until the last assessment, assessed up to 6 months.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2025.