- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo 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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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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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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
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 activo: 2
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The printed brochure is an educational brochure developed by the NIH.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Hemoglobina a1c
Periodo de tiempo: 6 meses
|
6 meses
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Diabetes self-care behaviors
Periodo de tiempo: 6 months
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6 months
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Dominick L Frosch, Ph.D., University of California, Los Angeles
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- G08-01-038-01
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .