- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01569477
Striving to Quit-Wisconsin Tobacco Quit Line
Striving to Quit: Wisconsin Tobacco Quit Line Tobacco Cessation Research
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Aim 1: To determine the extent to which contingent financial "treatment incentives" (i.e., incentives for biochemical verification visits, treatment engagement, and abstinence) versus "attendance incentives" (i.e., incentives for only attending the biochemical verification visits), increase rates of smoking cessation . Participants will be BadgerCare Plus tobacco users who enroll in Wisconsin Tobacco Quit Line (WTQL) services.
Aim 2: To determine the extent to which treatment incentives vs. attendance incentives increase rates of engagement in smoking cessation treatment through the WTQL when offered to BadgerCare Plus members who smoke.
Aim 3: To determine the cost-effectiveness of the smoking cessation program when paired with treatment incentives and when paired with attendance incentives.
Aim 4: To identify moderating and mediational effects regarding the clinical benefit of incentivized smoking treatment
Aim 5: To determine the reach of an incentivized smoking cessation treatment that depends upon primary care clinic staff, a fax-to-quit referral mechanism and a state quit line.
Tipo de estudio
Fase
- No aplica
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- enrollment in Wisconsin Medicaid (BadgerCare Plus)
- resides in study area (one of 25 counties)
- member of participating HMOs
- 18 or older
- English speaking
- has smoked daily (at least 5 cigarettes each day) over the last week
- willingness to attend visits at his/her PCC (primary care clinic) every 6 months (3 times over a 12 month period), provide urine samples, and complete follow-up phone calls
- willingness to inform the WTQL as to any change in address, phone number, clinic attended, or health plan.
Exclusion Criteria:
- not enrolled in Wisconsin Medicaid (BadgerCare Plus)
- not reside in study area
- not a member participating HMOs
- less than 18 years of age
- not English speaking
- does not smoke daily (at least 5 cigarettes each day) over the last week
- not willing to attend visits at his/her PCC (primary care clinic) every 6 months (3 times over a 12 month period), provide urine samples, and complete follow-up phone calls.
- not willing to inform the WTQL as to any change in address, phone number, clinic attended, or health plan.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: Treatment incentives
Incentives for biochemical verification visits, treatment engagement, and abstinence
|
Treatment incentives - incentives for biochemical verification visits, treatment engagement and abstinence
|
Comparador activo: Attendance incentive
Incentives for only attending the biochemical verification visits
|
Attendance Incentives - incentives for only attending the biochemical verification visits
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Abstinence from smoking
Periodo de tiempo: Measured 6 months after enrollment at follow-up assessment
|
The data will be the biochemically confirmed reports of abstinence for the past 7 days (i.e., 7-day point-prevalence abstinence)
|
Measured 6 months after enrollment at follow-up assessment
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Engagement in treatment
Periodo de tiempo: Measured 12 months after enrollment at follow-up assessment
|
The primary analyses will compare number of calls completed
|
Measured 12 months after enrollment at follow-up assessment
|
Cost-effectiveness
Periodo de tiempo: Measured 12 months after enrollment
|
The primary analysis will contrast the incremental costs of the treatment vs. attendance conditions by computing the Incremental Cost-Effectiveness Ratio (ICER) with regard to attaining 6-month abstinence.
|
Measured 12 months after enrollment
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Timothy B Baker, PhD, University of Wisconsin, Madison
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Anticipado)
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
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2012-0198
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
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. .