- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01569477
Striving to Quit-Wisconsin Tobacco Quit Line
Striving to Quit: Wisconsin Tobacco Quit Line Tobacco Cessation Research
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Phase
- N'est pas applicable
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Treatment incentives
Incentives for biochemical verification visits, treatment engagement, and abstinence
|
Treatment incentives - incentives for biochemical verification visits, treatment engagement and abstinence
|
|
Comparateur actif: Attendance incentive
Incentives for only attending the biochemical verification visits
|
Attendance Incentives - incentives for only attending the biochemical verification visits
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Abstinence from smoking
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Engagement in treatment
Délai: 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
Délai: 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
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Timothy B Baker, PhD, University of Wisconsin, Madison
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Anticipé)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2012-0198
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
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