- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT00668590
Improving Diabetes Care With Patient Decision Aids - A Trial in Community-based Primary Care
Improving Diabetes Care With Patient Decision Aids - A Randomized Controlled Trial in Community-based Primary Care
Mounting evidence documents the positive impact of using patient decision aids (PtDA) to facilitate shared decision-making (SDM) between patients and physicians in preference sensitive contexts. But overall use of PtDAs across the broader US healthcare system remains low. More compelling evidence is needed to make the case for policies that would accelerate adoption of PtDAs in routine clinical practice in primary care settings that serve diverse and economically disadvantaged populations. The investigators believe that it is now time to move beyond the subjective evaluations of PtDAs that are commonly reported in clinical trials of PtDAs, to evaluate whether these tools can also change health behavior and improve health outcomes. Therefore, the investigators will build on their expertise in working with community-based physicians to evaluate a newly developed PtDA focused on diabetes, using a mixed-methods approach. The investigators patient sample will be drawn from primary care practices serving African American, Latino and Caucasian patients. The investigators will conduct a 2-group randomized controlled trial to evaluate the effects of the diabetes PtDA, combined with telephone coaching, in increasing patient self-care and self-efficacy, increasing diabetes knowledge and improving clinical measures including glycosylated hemoglobin A1c, lipids and blood pressure. The investigators will also explore variation in effects of the patient decision aid, comparing African American, Latino and Caucasian patients and conduct in-depth interviews with a randomly selected subset of trial participants to explore patient perceptions of the decision aid and variation across racial/ethnic groups. The investigators hypothesize that, compared to the control condition, participants assigned to receiving the video PtDA program and telephone coaching will report: greater self-efficacy and diabetes knowledge, more engagement in self-care behaviors, better glycemic control as measured by hemoglobin A1c, as well as lower quantitative LDL and blood pressure levels. The conceptual model guiding the investigators trial is the Integrative Model of Behavior Change. The model includes three primary determinants of behavior:
- attitudes toward performing the behavior
- perceived social norms about performing the behavior
- self-efficacy. The investigators expect the diabetes PtDA to affect each of these constructs directly or indirectly.
Visão geral do estudo
Status
Condições
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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California
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Los Angeles, California, Estados Unidos, 90024
- UCLA Internal Medicine practices
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Los Angeles, California, Estados Unidos, 90291
- Community-based primary care practices
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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:
- At least 40 years old.
- Diagnosed with Type 2 diabetes at least 1 year ago.
- Attending the clinic for a routine diabetes follow-up visit.
- Completed at least 2 clinic visits in the past 12 months.
- Glycosylated hemoglobin A1c equal or greater than 8.0%
- Owns a DVD player and television at home
- Willing to provide informed consent.
Exclusion Criteria:
- Primary language other than English.
- Severe visual impairment
- Currently enrolled in a diabetes education or support program, or participated in a diabetes education or support program in the last 6 months.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: 1
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The decision aid is a 30 minute video program that educates patients about their role in diabetes care.
Telephone coaching will assist patients in initiating behavior change.
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Comparador Ativo: 2
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The printed brochure is an educational brochure developed by the NIH.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
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Hemoglobina a1c
Prazo: 6 meses
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6 meses
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Medidas de resultados secundários
Medida de resultado |
Prazo |
---|---|
Diabetes self-care behaviors
Prazo: 6 months
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6 months
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Dominick L Frosch, Ph.D., University of California, Los Angeles
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
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 (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
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
- G08-01-038-01
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 .