- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT03064724
Practice-based Intervention for Vietnamese and Korean Patients
22 de fevereiro de 2017 atualizado por: Thu Quach, Asian Health Services
This pilot project examined the feasibility of an multilingual interactive video education intervention "an interactive Mobile Doctor intervention (iMD)" to promote patient-provider discussion on tobacco use for Korean- and Vietnamese-speaking male patients at primary care settings.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Descrição detalhada
While California has made significant strides in tobacco control and is leading the nation in reducing smoking use, the decline is not observed in all groups.
Select groups still have much higher smoking rates and thus bear an unequal burden of tobacco-related illnesses and deaths.
Of important note, Asian American men as a combined group have a higher smoking rate than non-Hispanic Whites (22% vs. 18%, respectively); in particular, the highest smoking prevalence has been observed in Vietnamese (31%) and Korean (30%) men among major Asian subgroups.
Research also shows that smoking rates are higher for Asian American men with low acculturation (e.g., immigrant status, low English proficiency) than for those who are more acculturated; yet the reverse trend is observed in Asian American women.
These findings underscore the need for more targeted tobacco control efforts.
The scientific literature suggests that provider advice to quit smoking can influence a smoker's decision to quit.
However, research has shown that Asian Americans are less likely to receive such provider advice.
Providers often have very limited face-time with patients during the short clinic visit, which presents a challenge as to whether they can incorporate smoking cessation messages during the visit.
Overall, little research has focused on smoking cessation in the clinic setting, particularly research that focuses on Asian Americans.
The purpose of the pilot study was to develop a more streamlined smoking cessation intervention that can be integrated into the clinic visit, especially to maximize the time when patients are waiting to see their providers.
The research question was whether providing culturally appropriate video education that includes provider advice and was tailored to a patient's readiness for quitting smoking will increase whether a patient receives smoking cessation education according to the recommended Clinical Practice Guideline and whether this results in a decrease in tobacco use in low-income Vietnamese and Korean patients.
Using a community-based participatory research approach, the investigators created the iMD that delivers tailored in-language video messages via a mobile tablet to Korean and Vietnamese male smokers right before their clinic visit with a provider.
iMD delivers the "5 A's" and generates a bilingual tailored printout.
Participants were Korean- and Vietnamese-speaking patients who self-identify as daily smokers and receive primary care at a federally-qualified health center.
This study evaluated the feasibility and acceptability of iMD from the patients' perspectives.
This study examined patient-provider discussion on tobacco use from patients' self-report and electronic health record (EHR), and self-reported quit attempts and smoking abstinence at 3 months post iMD visit.
Tipo de estudo
Intervencional
Inscrição (Real)
47
Estágio
- Não aplicável
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos a 75 anos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Macho
Descrição
Inclusion Criteria:
- current smokers identified on electronic health records (EHR)
- have a scheduled primary care visit during the recruitment period
Exclusion Criteria:
- already quit smoking or not smoking daily in the past 7 days
- had already quit smoking or not smoking daily in the past 7 days
- had canceled or rescheduled their primary care visit outside of the study period
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: Smoking Cessation Group
Patients received the interactive mobile doctor (iMD) intervention.
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iMD delivers tailored interactive video education via a mobile tablet to smoking patients right before their clinic visit with a provider.
iMD delivers the "5 A's" (ask, advise, assess, assist, and arrange) and generates a bilingual tailored printout, which aims to increase patient-provider discussion on tobacco use and to promote smoking cessation.
This version of iMD delivers the intervention in Korean or Vietnamese languages as preferred by the patient.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Participation Rate
Prazo: Baseline
|
proportion of eligible participants consent to participate
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Baseline
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Acceptability
Prazo: through study completion, an average of 1 year
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proportion of participants who rated the intervention as moderately to extremely satisfied
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through study completion, an average of 1 year
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Patient-provider discussion
Prazo: "through study completion, an average of 1 year
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self-reported by patient whether discussion on tobacco use took place at the indexed clinical encounter
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"through study completion, an average of 1 year
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Physician delivery of 5As
Prazo: "through study completion, an average of 1 year
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EHR-documented physician's delivery of assess, advice, assist, or arrange at the indexed clinical encounter
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"through study completion, an average of 1 year
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Quit attempt
Prazo: 3-month
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self-reported at least one or more 24 hour quit attempts
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3-month
|
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Abstinence
Prazo: 3-month
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self-reported 7-day point prevalent smoking abstinence
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3-month
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Thu Quach, PhD, MPH, Asian Health Services
- Investigador principal: Janice Tsoh, University of California, San Francisco
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo
1 de agosto de 2012
Conclusão Primária (Real)
1 de julho de 2015
Conclusão do estudo (Real)
1 de julho de 2015
Datas de inscrição no estudo
Enviado pela primeira vez
20 de fevereiro de 2017
Enviado pela primeira vez que atendeu aos critérios de CQ
22 de fevereiro de 2017
Primeira postagem (Real)
27 de fevereiro de 2017
Atualizações de registro de estudo
Última Atualização Postada (Real)
27 de fevereiro de 2017
Última atualização enviada que atendeu aos critérios de controle de qualidade
22 de fevereiro de 2017
Última verificação
1 de fevereiro de 2017
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- 21BT-0056
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