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A Pilot Study of the Learn, Connect, and Quit Mobile Application

9 de junio de 2020 actualizado por: University of Wisconsin, Madison
This research study aims to develop and test the effectiveness of a mobile application for patients who smoke to use while waiting in the clinic exam room to see their provider. The application will present patients with a variety of videos designed to increase their engagement in evidence-based smoking cessation treatment and offer them action steps to engage in smoking-related treatment or discussions with their provider.

Descripción general del estudio

Estado

Terminado

Condiciones

Descripción detallada

The overarching goal of this study is to develop a novel, effective mobile application for patients to use while waiting in the clinic exam room to see their provider and to access on-line after their visit. The Learn, Connect, and Quit (LCQ) application will present patients with a variety of videos designed to increase their understanding of, and engagement in, evidence-based smoking cessation treatment (e.g., videos that address barriers to cessation and explain treatment options). The LCQ app will also be coordinated within the clinical care system to allow patients to self-refer for smoking treatment and will serve as a prompt to begin a conversation with the provider thereby connecting smokers to evidence-based treatment with minimal staff burden, thus, increasing the feasibility and sustainability of this intervention. This research will pursue the following specific aims:

Specific Aim 1: Develop the Learn, Connect, and Quit mobile application to: 1) present educational and motivational content in an easily accessible manner (i.e., via videos); and 2) provide avenues for smokers to connect to evidence-based treatment (e.g., request a referral to the Wisconsin Tobacco Quitline via the app, initiate a discussion with their provider).

Specific Aim 2: Identify optimal implementation procedures and clinical workflows to facilitate the use of the LCQ app within the clinical setting.

Specific Aim 3: Establish the feasibility, acceptability, and preliminary effects of the Learn, Connect, and Quit app among smokers in a primary care clinic to support an NIH R01 application.

This research will create an innovative, patient-driven intervention that can be integrated into healthcare systems and leverage the patient wait times in traditional clinical settings to provide motivational content and treatment information to increase: motivation, smoking treatment engagement, and connections with evidence-based treatment resources. This innovative product will then be tested in larger implementation trials with external funding.

Tipo de estudio

De observación

Inscripción (Actual)

16

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

    • Wisconsin
      • Madison, Wisconsin, Estados Unidos, 53711
        • University of Wisconsin Center for Tobacco Research and Intervention

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

Sí

Géneros elegibles para el estudio

Todos

Método de muestreo

Muestra no probabilística

Población de estudio

The Smoker Participant Group will consist of adult English-speaking smokers attending a clinic visit at their primary care clinic.

The Clinic Staff Group will consist of adult staff (rooming staff and clinical providers) at the primary care clinic where Smoker Participant Group participants will be recruited.

Descripción

Inclusion Criteria for Smoker Participant Group:

  • participant be age 18 or older, speak and understand English, smoke cigarettes, and complete the referral form agreeing to be contacted for an assessment

Exclusion Criteria:

  • none

Inclusion Criteria for Clinic Staff Group:

  • must be either rooming staff or clinical provider (e.g., physician, nurse practitioner, etc.)

Exclusion Criteria:

  • none

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

Cohortes e Intervenciones

Grupo / Cohorte
Intervención / Tratamiento
Patients Who Smoke
This group will consist of up to 100 English-speaking adult smokers recruited from their primary care clinic who are willing to complete a brief phone-based interview about their experience in using the "Learn, Connect, and Quit" (LCQ) tablet-based mobile application. The LCQ app presents smoking and cessation-related educational and motivational content in an easily accessible manner (i.e., via videos) and provides avenues for smokers to connect to evidence-based treatment.
The Learn, Connect, and Quit (LCQ) Mobile Application is an application for electronic tablets that can: assess smokers' interest in quitting; answer smokers' questions about smoking, quitting, and available treatments; provide information about treatment options; communicate information about patients' smoking status, concerns, and treatment interest to their provider; and connect patients with treatment options including the Wisconsin Tobacco Quitline (WTQL), and other smoking intervention resources provided by their healthcare system.
Clinic Staff
Rooming staff and physicians from the primary care clinic (where "Patients Who Smoke" group participants are recruited) will be asked to participate in interviews about the feasibility of implementing the LCQ app including implementation burden, impact on clinical workload, and clinical utility of the app (i.e., Did patients ask more questions about smoking treatment? How challenging was it to try to give all smokers the app to explore?).
The Learn, Connect, and Quit (LCQ) Mobile Application is an application for electronic tablets that can: assess smokers' interest in quitting; answer smokers' questions about smoking, quitting, and available treatments; provide information about treatment options; communicate information about patients' smoking status, concerns, and treatment interest to their provider; and connect patients with treatment options including the Wisconsin Tobacco Quitline (WTQL), and other smoking intervention resources provided by their healthcare system.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Total time spent watching videos
Periodo de tiempo: One day
Total minutes spent watching videos presented on the Learn, Connect, and Quit Mobile Application
One day

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Clinical Utility of the Learn, Connect, and Quit Mobile Application
Periodo de tiempo: One day
Clinic staff rating of whether they would like to see use of the LCQ app continue (yes/no)
One day

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

  • Investigador principal: Megan E Piper, PhD, University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public Health

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 (Actual)

18 de junio de 2019

Finalización primaria (Actual)

2 de octubre de 2019

Finalización del estudio (Actual)

19 de diciembre de 2019

Fechas de registro del estudio

Enviado por primera vez

5 de junio de 2019

Primero enviado que cumplió con los criterios de control de calidad

5 de junio de 2019

Publicado por primera vez (Actual)

7 de junio de 2019

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

11 de junio de 2020

Última actualización enviada que cumplió con los criterios de control de calidad

9 de junio de 2020

Última verificación

1 de junio de 2020

Más información

Términos relacionados con este estudio

Palabras clave

Otros números de identificación del estudio

  • 2019-0274
  • A534253 (Otro identificador: UW- Madison)
  • SMPH/MEDICINE/GEN INT MD (Otro identificador: UW Madison)
  • R35CA197573 (Subvención/contrato del NIH de EE. UU.)
  • Protocol Version 1/22/2019 (Otro identificador: UW Madison)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

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. .

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