Um programa de cuidados habilitado para cuidadores em espanhol (CECP)
Melhorando a igualdade de saúde para famílias hispânicas/latinas que vivem com demência, validando um programa de cuidados habilitados para cuidadores (CECP) em espanhol em participantes do PACE
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.
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
California
-
Carlsbad, California, Estados Unidos, 92010
- Ceresti Health
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Cuidados de suporte
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
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. |
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. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Longitudinal Engagement
Prazo: 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. |
From the date of enrollment in the program until the last assessment, assessed up to 6 months.
|
|
Intensity of Engagement
Prazo: 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. |
From the date of enrollment in the program until the last assessment, assessed up to 6 months.
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Centers for Disease Control and Prevention (CDC) Healthy Days Measure (Spanish version)
Prazo: From the date of enrollment until the last monthly assessment, assessed every month up to 6 months
|
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)
Prazo: From the date of enrollment until the last monthly assessment, assessed every month up to 6 months
|
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)
Prazo: From From the date of enrollment until the last monthly assessment, assessed every month up to 6 months
|
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
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Dirk Soenksen, CEO
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- CER-2024-111-001
- 1R43AG088143-01 (Concessão/Contrato do NIH dos EUA)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
De-identified, aggregated, summarized data will be made available for sharing.
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .