Evaluación de un programa de telemedicina para dejar de fumar en prácticas rurales de atención primaria
4 de octubre de 2012 actualizado por: Kimber Richter, PhD, MPH, MA
Telemedicina para dejar de fumar en atención primaria rural
Las personas que fuman cigarrillos y viven en áreas rurales pueden no tener acceso a una amplia variedad de recursos para ayudarlos a dejar de fumar.
Este estudio evaluará dos programas para dejar de fumar, un programa de telemedicina basado en Internet y un programa de línea telefónica para dejar de fumar, entre residentes rurales.
Descripción general del estudio
Estado
Terminado
Condiciones
Descripción detallada
Las personas que viven en áreas rurales tienen más probabilidades de fumar cigarrillos que las personas que viven en áreas urbanas y suburbanas. Sin embargo, es posible que muchos recursos y programas para dejar de fumar no estén disponibles para los residentes de áreas rurales. Se ha comprobado que las líneas telefónicas gratuitas para dejar de fumar ayudan a las personas a dejar de fumar y están disponibles para casi todas las personas que viven en los Estados Unidos, pero solo entre el 1 % y el 5 % de los fumadores realmente las usan. Otra opción para ayudar a las personas a dejar de fumar puede implicar que los médicos proporcionen programas para dejar de fumar en sus consultorios o clínicas; sin embargo, la mayoría de los consultorios médicos no cuentan con los recursos para brindar este tipo de servicio. La telemedicina proporciona información médica por teléfono o por Internet mediante el uso de diversas tecnologías, incluidas cámaras web o equipos de videoconferencia. Se ha utilizado con éxito para brindar atención psiquiátrica y asesoramiento sobre adicciones, pero no se han realizado estudios que hayan examinado la eficacia de un programa de telemedicina para dejar de fumar. El propósito de este estudio es comparar la efectividad de un programa de telemedicina para dejar de fumar que se lleva a cabo en el consultorio de un médico versus la efectividad de un programa tradicional de línea telefónica para dejar de fumar entre fumadores rurales.
El estudio se llevará a cabo en 25 consultorios médicos rurales en Kansas. Los participantes serán asignados al azar para participar en un programa de línea telefónica para dejar de fumar o un programa de telemedicina. Los participantes en el programa de la línea telefónica para dejar de fumar recibirán cuatro sesiones de asesoramiento telefónico para dejar de fumar de parte de consejeros para dejar de fumar durante un período de 8 semanas. Los participantes en el programa de telemedicina recibirán cuatro sesiones de asesoramiento de telemedicina de parte de consejeros para dejar de fumar durante un período de 8 semanas, que se entregarán a través de cámaras web bidireccionales en computadoras en los consultorios médicos. Todos los participantes recibirán folletos educativos y planes para dejar de fumar personalizados, incluida información sobre medicamentos para dejar de fumar. Al inicio del estudio y en los Meses 3, 6 y 12, todos los participantes participarán en entrevistas telefónicas con los investigadores del estudio para evaluar los hábitos de fumar. Al inicio y al mes 12, los participantes enviarán por correo una muestra de saliva a los investigadores con el fin de determinar el nivel de nicotina en el cuerpo.
Tipo de estudio
Intervencionista
Inscripción (Actual)
566
Fase
- Fase 3
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Kansas
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Kansas City, Kansas, Estados Unidos, 66160
- University of Kansas Medical Center
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Criterios de inclusión:
- fuma cigarrillos todos los dias
- Fuma cinco o más cigarrillos por día.
- Ha fumado cigarrillos durante al menos 1 año antes de ingresar al estudio
- Tiene domicilio y número de teléfono
- Dispuesto a participar en evaluaciones telefónicas
- Dispuesto a ser asignado a cualquiera de los dos programas de estudio.
Criterio de exclusión:
- embarazada o amamantando
- Otro miembro del hogar está inscrito en el estudio.
- Mudanza fuera del área de residencia en los 14 meses posteriores al ingreso al estudio
- El proveedor de atención primaria no participa en el estudio
- Uso de otras formas de productos de tabaco (por ejemplo, cigarros, saliva, rapé) además de cigarrillos
- Uso de un medicamento para dejar de fumar
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: 1
Los participantes participarán en un programa de telemedicina para dejar de fumar.
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Los participantes recibirán cuatro sesiones de asesoramiento para dejar de fumar por telemedicina durante un período de 8 semanas.
Las sesiones de telemedicina se realizarán mediante cámaras web bidireccionales montadas en computadoras de escritorio en los consultorios médicos.
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Comparador activo: 2
Los participantes participarán en un programa para dejar de fumar en una línea telefónica para dejar de fumar.
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Los participantes recibirán cuatro sesiones de asesoramiento para dejar de fumar por teléfono en sus hogares durante un período de 8 semanas.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Abstinencia de prevalencia puntual de 7 días
Periodo de tiempo: Medido en los meses 3, 6 y 12
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Medido en los meses 3, 6 y 12
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Abstinencia prolongada
Periodo de tiempo: Medido en los meses 3, 6 y 12
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Medido en los meses 3, 6 y 12
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Kimber P. Richter, PhD, MPH, MA, University of Kansas
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
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Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de junio de 2009
Finalización primaria (Actual)
1 de abril de 2012
Finalización del estudio (Actual)
1 de abril de 2012
Fechas de registro del estudio
Enviado por primera vez
12 de febrero de 2009
Primero enviado que cumplió con los criterios de control de calidad
12 de febrero de 2009
Publicado por primera vez (Estimar)
13 de febrero de 2009
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
5 de octubre de 2012
Última actualización enviada que cumplió con los criterios de control de calidad
4 de octubre de 2012
Última verificación
1 de octubre de 2012
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- 625
- R01HL087643-01A2 (Subvención/contrato del NIH de EE. UU.)
- HL087643-01A2
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. .