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- Ensaio Clínico NCT06257082
Intervenção de educação do paciente baseada em vídeo para exames oftalmológicos de diabéticos em comunidades latinas
Desenvolvimento de uma intervenção culturalmente adaptada e baseada em vídeo para educação do paciente para aumentar a triagem ocular de diabéticos e o uso de teleoftalmologia em comunidades latinas
An online survey (n=1,500) and 4 focus groups will be conducted with Latinx patients with diabetes (n=20) to obtain preliminary data regarding whether and how patient and clinician video testimonial interventions (n=6) increase eye health literacy and trust in healthcare.
Visão geral do estudo
Descrição detalhada
3 Latinx patients with diabetes and 3 Latinx clinicians will be recruited to videotape testimonials regarding the importance of diabetic eye screening and teleophthalmology use from their personal experiences. The investigators will structure the testimonials as a series of responses to a brief set of interview questions, or prompts, designed to elicit key messages previously identified by our community stakeholders as being particularly important, based on our prior studies and those of others and conducted in Spanish (with English subtitles).
After the Latinx patient and clinician video testimonials are recorded, a community outreach specialist bilingual in Spanish and English will facilitate a series of 4 community stakeholder meetings (90 min. each) to develop the culturally-adapted, video-based patient education intervention to increase diabetic eye screening and teleophthalmology use among Latinos.
After patient education videos are developed, an online survey will be conducted (n=1500) to test 3 versions of the video-based patient education intervention: (1) patient + clinician combined testimonials, (2) patient testimonials only, (3) clinician testimonials only, and compare them to 2 control conditions: (1) a standard educational video, publicly available online from the National Eye Institute, and (2) pre-video questionnaire-only control in a mixed-effects randomized design with pre- and post-measures (video conditions treated as the between-subjects factor).
Finally, a community outreach specialist bilingual in Spanish and English will facilitate focus groups (60-90 minutes) in the participants' preferred language (participants will be grouped based on their preference for either Spanish or English). Focus groups will begin by having each participant complete a brief survey instrument that will be read aloud and adapted from validated survey instruments for eye health literacy and trust in healthcare (CADEES and T-HCT scale). Participants will then silently view the video-based, patient education intervention (patient + clinician combined version). Afterwards, they will complete the same brief survey instrument to obtain a pre-/post-comparison of any differences in their responses that may result from viewing the video intervention.
Together with the online survey results, the investigators will test the intervention's ability to increase eye health literacy and trust in healthcare for obtaining eye care.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Wisconsin
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Madison, Wisconsin, Estados Unidos, 53792
- UW Hospital and Clinics
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-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria (online survey participants):
- Self-Identifies as Hispanic or Latino
Inclusion Criteria (patient video testimonials):
- Self-Identifies as Hispanic or Latino
- diagnosed with diabetes
- treated at Access Community Health Centers and UW Health in Madison, WI
Inclusion Criteria (clinician video testimonials):
- Self-Identifies as Hispanic or Latino
- clinician who treats patients with diabetes at Access Community Health Centers and UW Health in Madison, WI
Inclusion Criteria (focus group participants):
- Self-Identifies as Hispanic or Latino
- diagnosed with type 1 or type 2 diabetes
Exclusion Criteria:
-
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Pesquisa de serviços de saúde
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Comparador Ativo: Depoimentos apenas para médicos
|
Participants must self-identify as Latinx adults and complete a brief online survey adapted from validated survey instruments for eye health literacy and trust in healthcare (CADEES and T-HCT scale) both before and after viewing the video-based, patient education intervention to obtain a pre to post-comparison of any differences in their responses. |
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Comparador Ativo: Depoimentos apenas de pacientes
|
Participants must self-identify as Latinx adults and complete a brief online survey adapted from validated survey instruments for eye health literacy and trust in healthcare (CADEES and T-HCT scale) both before and after viewing the video-based, patient education intervention to obtain a pre to post-comparison of any differences in their responses. |
|
Comparador Ativo: Controle de vídeo do National Eye Institute
|
Participants must self-identify as Latinx adults and complete a brief online survey adapted from validated survey instruments for eye health literacy and trust in healthcare (CADEES and T-HCT scale) both before and after viewing the video-based, patient education intervention to obtain a pre to post-comparison of any differences in their responses. |
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Comparador Ativo: Controle apenas do questionário pré-vídeo
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Participants must self-identify as Latinx adults and complete a brief online survey adapted from validated survey instruments for eye health literacy and trust in healthcare (CADEES and T-HCT scale) both before and after viewing the video-based, patient education intervention to obtain a pre to post-comparison of any differences in their responses. |
|
Comparador Ativo: Patient plus Clinician Combined Testimonials
In addition to being randomized for online survey participants, focus groups will view patient plus clinician combined testimonials. |
Participants must self-identify as Latinx adults and complete a brief online survey adapted from validated survey instruments for eye health literacy and trust in healthcare (CADEES and T-HCT scale) both before and after viewing the video-based, patient education intervention to obtain a pre to post-comparison of any differences in their responses. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change in Eye Health Literacy as measured by Compliance with Annual Diabetic Eye Exams Survey (CADEES)
Prazo: pre and post video testimonial intervention (up to 90 minutes)
|
CADEES is scored from 1-5 where higher scores indicate increase eye health literacy. |
pre and post video testimonial intervention (up to 90 minutes)
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change in Trust in Healthcare as measured by Trust in the Health Care Team (T-HCT) scale score
Prazo: pre and post video testimonial intervention (up to 90 minutes)
|
T-HCT is scored from 1-5 where higher scores indicate increased trust in healthcare. |
pre and post video testimonial intervention (up to 90 minutes)
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Yao Liu, MD, MS, University of Wisconsin, Madison
Publicações e links úteis
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
- 2024-1566
- A536000 (Outro identificador: UW Madison)
- 1UG1EY032446-01 (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 data regarding patient demographics, whether they obtained diabetic eye screening, had teleophthalmology performed, any vision-threatening eye condition identified by teleophthalmology, and whether they followed-up for in-person eye care if they screened positive will be available to share.
Prazo de Compartilhamento de IPD
up to 7 years after the completion of the primary outcome
Critérios de acesso de compartilhamento IPD
contact study PI for access
Tipo de informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
- SEIVA
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