- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT03501472
Pictorial Warning Labels, Numeracy, and Memory for Numeric Cigarette Health-risk Information Over Time
Aperçu de l'étude
Statut
Les conditions
Type d'étude
Inscription (Réel)
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:
- at least 18 years old
- have smoked 100+ lifetime cigarettes
- currently smoke "every day" or "some days."
- US resident
Exclusion Criteria:
- have not ever smoked a cigarette
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation factorielle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Expérimental: Text-only PWL, immediate post
Exposure to 4 FDA-mandated warning labels and numeric risk information for 8 outcomes related to those warnings (2 outcomes for each PWL; half as percentage, half as frequency) Posttest measures (e.g., memory, risk perceptions, quit intentions) administered immediately following last exposure to warning labels |
|
Expérimental: Text-only PWL, delay posttest
Exposure to 4 FDA-mandated warning labels and numeric risk information for 8 outcomes related to those warnings (2 outcomes for each PWL; half as percentage, half as frequency) Posttest measures (e.g., memory, risk perceptions, quit intentions) administered 6 weeks following last exposure to warning labels |
|
Expérimental: Low-emot PWL, immed post
Exposure to 4 FDA-mandated warning labels paired with images that elicit little emotion and numeric risk information for 8 outcomes related to those warnings (2 outcomes for each PWL; half as percentage, half as frequency) Posttest measures (e.g., memory, risk perceptions, quit intentions) administered immediately following last exposure to warning labels |
|
Expérimental: Low-emot PWL, delay posttest
Exposure to 4 FDA-mandated warning labels paired with images that elicit little emotion and numeric risk information for 8 outcomes related to those warnings (2 outcomes for each PWL; half as percentage, half as frequency) Posttest measures (e.g., memory, risk perceptions, quit intentions) administered 6 weeks following last exposure to warning labels |
|
Expérimental: High-emot PWL, immed posttest
Exposure to 4 FDA-mandated warning labels paired with images that elicit high emotion and numeric risk information for 8 outcomes related to those warnings (2 outcomes for each PWL; half as percentage, half as frequency) Posttest measures (e.g., memory, risk perceptions, quit intentions) administered immediately following last exposure to warning labels |
|
Expérimental: High-emot PWL, delay posttest
Exposure to 4 FDA-mandated warning labels paired with images that elicit high emotion and numeric risk information for 8 outcomes related to those warnings (2 outcomes for each PWL; half as percentage, half as frequency) Posttest measures (e.g., memory, risk perceptions, quit intentions) administered 6 weeks following last exposure to warning labels |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
numeric risk recall
Délai: immediately following last exposure or after 6-week delay
|
free recall for numeric risks presented in labels (e.g., ____% of smokers die before age 85), both for smokers and nonsmokers
|
immediately following last exposure or after 6-week delay
|
numeric risk recognition
Délai: immediately following last exposure or after 6-week delay
|
Participants answered one multiple choice question about the numeric risk for smokers and nonsmokers (combined in one question) for each of the 8 outcomes that had been paired with the PWLs.
For each question, there were four decoy responses.
|
immediately following last exposure or after 6-week delay
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
smoking risk perceptions
Délai: immediately following last exposure or after 6-week delay
|
Participants completed several scale items about how much risk they perceived smoking posed to them (e.g., "Compared to the average nonsmoker your age, gender, and race, how would you rate your chances of": 1) "getting a life threatening illness because of smoking," 2) "getting lung cancer," and 3) "dying at a younger age than average" (-3 = Much lower, +3 = Much higher)) They also gave verbal likelihood ratings for each of the 8 outcomes of smoking that had been paired with the labels (e.g., "Thinking of risks that you were shown in the warnings, what is the likelihood of a smoker [non-smoker] dying from heart disease?," 0=impossible, 11=certain) |
immediately following last exposure or after 6-week delay
|
smoking risk knowledge
Délai: immediately following last exposure or after 6-week delay
|
Participants listed as many risks of smoking as they could think of.
|
immediately following last exposure or after 6-week delay
|
quit intentions
Délai: immediately following last exposure or after 6-week delay
|
Participants intentions to quit smoking, Likelihood of smoking within next 30 days, next year (-3 = very unlikely, 3 = very likely)
|
immediately following last exposure or after 6-week delay
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- P50CA180908A2b
- P50CA180908 (Subvention/contrat des NIH des États-Unis)
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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