- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01331226
Support Person Intervention to Promote a Smoking Helpline (ClearWay #4)
Support Person Effectiveness Study to Promote Smoker Utilization of the QUITPLAN Helpline
Descripción general del estudio
Estado
Condiciones
Descripción detallada
We will conduct a randomized clinical trial within the ongoing service of the QUITPLAN® Helpline. Our primary aim is to examine the efficacy of two levels of telephone counseling for support persons (1 or 3 sessions) compared with a control condition on the proportion of smokers who call the Helpline over the 7 month follow-up period. We hypothesize a dose response relationship between number of telephone sessions provided to the support persons and smoker calls to the Helpline. Additional aims are to examine smoker quit attempts and cessation, and cost-effectiveness of the interventions.
Nonsmoking adult support persons (N=1020) residing in Minnesota will be enrolled and randomly assigned to one of three study conditions: (1) control condition -written self-help materials, (2) written materials plus one telephone session, or (3) written materials plus three telephone sessions. Outcome assessments will be completed by support persons and smokers at post-treatment (week 4) and at 7 month follow-up.
This design will allow for evaluation of whether results from our previous trial (Patten et al., in press, AJPM) can be replicated when the intervention is implemented within a "real-world" setting. That is all support person intervention calls will be delivered by the Helpline. Moreover, we will examine the potential efficacy and cost-effectiveness of a streamlined version of the intervention (i.e., 1 call). Furthermore, the proposed study will provide new data on quit attempts and cessation among the smokers. Ultimately, positive findings from this line of research could serve as the basis for expanding the range of helpline services to nonsmokers.
Tipo de estudio
Inscripción (Anticipado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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-
Minnesota
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Rochester, Minnesota, Estados Unidos, 55905
- Mayo Clinic
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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:
The support person must
- reside in Minnesota
- be 18 years of age or older
- provide written informed consent
- be a never or former cigarette smoker (no cigarette smoking in the past 6 months)
- want to support a current cigarette smoker (has smoked a total of >1 cigarettes during the past 7 days) who is 18 years of age or older, resides in Minnesota, and has not been enrolled in a helpline or any other cessation program in the last 3 months
- be able and willing to participate in all aspects of the study
- have access to a working telephone
- have current and anticipated contact (any combination of face-to-face, telephone, text messaging, or electronic mail) with the smoker on at least 3 days a week for the 30 week study duration.
Exclusion Criteria:
- Support persons will be excluded if another support person from the same household has enrolled.
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: 3 session telephone counseling
|
3 sessions of telephone counseling
|
|
Experimental: 1 session telephone counseling
|
1 session of telephone counseling
|
|
Comparador activo: written materials
|
written materials only
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
helpline utilization
Periodo de tiempo: At 7 month follow-up
|
smoker calls to the helpline
|
At 7 month follow-up
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
smoker quit attempts and cessation
Periodo de tiempo: 7 month follow-up
|
7 month follow-up
|
Colaboradores e Investigadores
Patrocinador
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
Otros números de identificación del estudio
- 11-001796
- 10-008318 (Otro identificador: Mayo Clinic)
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