- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02613689
Addressing Tobacco Use Disparities Through an Innovative Mobile Phone Intervention
Addressing Tobacco Use Disparities Through an Innovative Mobile Phone Intervention: The Text to Forgo Smokeless Tobacco
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Participants will be randomized to either the Scheduled Gradual Reduction (SGR) group or the control group. All participants in both groups will complete surveys at the baseline, end of program, and 6 month time points. All participants in both groups will also receive supportive counseling text messages at various times during the day over a period of 4 weeks.
Participants assigned to the SGR intervention group will receive their intervention, in addition to the supportive counseling messages received by the control group, via text message over a period of four weeks. Participants will initially report their smokeless tobacco use according to their usual habit, and over the course of the intervention be directed via text message precise times to start and stop each instance of smokeless tobacco use, gradually reducing the occurrences of use.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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North Carolina
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Durham, North Carolina, Estados Unidos, 27710
- Duke University School of Nursing
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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:
- Over 18 years of age
- Have used smokeless tobacco for the last year, currently (past 30 days) uses smokeless tobacco daily, and use of at least one or more tins/cans per week
- Have an address in a rural census tract defined by a RUCA code of 4-10.
- Interested in participating in a cessation program
- Have access to a cell phone with unlimited texting ability and have knowledge of text messaging
Exclusion Criteria:
- Non-English speaking
- Have smoked cigarettes or used any other tobacco product in the past 30 days (i.e., dual user)
- Currently participating in a smokeless tobacco cessation study
- Family member participating in a smokeless tobacco cessation study
Plan de estudios
¿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 |
---|---|
Experimental: Scheduled Gradual Reduction (SGR)
Subjects will receive the Scheduled Gradual Reduction (SGR) intervention, as well as SMS support text messages.
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Participants in this group will group will receive the Scheduled Gradual Reduction (SGR) smokeless tobacco cessation reduction intervention via text message over a period of four weeks.
Participants will initially report their smokeless tobacco use according to their usual habit, and over the course of the intervention be directed via text message precise times to start and stop each instance of smokeless tobacco use, gradually reducing the occurrences of use.
In addition, this group will also receive the support messages that are sent to the control group.
Participants in this group will receive text messages about smokeless tobacco cessation in the form of counseling messages at various times throughout the day over a period of four weeks.
|
Comparador activo: Control Group
Subjects will receive SMS support text messages
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Participants in this group will receive text messages about smokeless tobacco cessation in the form of counseling messages at various times throughout the day over a period of four weeks.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Proportion of Return Text Messages sent in Response to SGR Intervention
Periodo de tiempo: 1 month
|
Assessed via text history
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1 month
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Proportion of Support Messages Read by Participants
Periodo de tiempo: 1 month
|
Self-report
|
1 month
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Ratings of Usefulness of the Intervention Received
Periodo de tiempo: 1 month
|
Ratings will be assessed via patient questionnaire.
|
1 month
|
Quit Rate at 1 month
Periodo de tiempo: 1 month
|
Quit rate will be assessed by participant self report via questionnaires.
Participants will also be asked to provide a saliva sample to check for nicotine if they report that they have quit using smokeless tobacco.
|
1 month
|
Quit Rate at 6 Months
Periodo de tiempo: 6 months
|
Quit rate will be assessed by participant self report via questionnaires.
Participants will also be asked to provide a saliva sample to check for nicotine if they report that they have quit using smokeless tobacco.
|
6 months
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Devon Noonan, PhD, Duke University School of Nursing
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
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 (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- Pro00063791
- 1R15CA198841-01 (Subvención/contrato del NIH de EE. UU.)
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. .