- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT05297370
Mixed and Match vs One-size-fits-all
22 mars 2022 mis à jour par: Dr Katherine Lam, The Hong Kong Polytechnic University
Mixed and Match Versus One-size-fits-all: A Randomized Controlled Trial of Self-determination Theory on a Menu of Smoking Cessation Options (SDTM) Among Adult Smokers
Most existing smoking cessation services are based on '5A's' and '5R's' models which are recognized by the World Health Organization as a standardized tool for smoking cessation.
While there are more techniques that are known to be effective and could be incorporated in existing smoking cessation interventions to further promote their effectiveness.
This study is to examine the effectiveness SDTM in assisting adult smokers in Hong Kong to quit.
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Intervention / Traitement
Description détaillée
A randomized controlled trial (RCT) will be conducted.
One-hundred adult smokers aged 25 or above will be recruited from smoking hotspots in Hong Kong.
Participants in the intervention group will be contacted by our trained research assistant to receive a telephone counselling session at baseline.
Participants can choose to receive their own smoking cessation treatment options from our menu.
Control group participants will only receive a self-help quitting leaflet
Type d'étude
Interventionnel
Inscription (Anticipé)
500
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Katherine Lam, PhD
- Numéro de téléphone: 27666420
- E-mail: kwkatlam@polyu.edu.hk
Sauvegarde des contacts de l'étude
- Nom: Eva Ho, PhD
- Numéro de téléphone: 27666417
- E-mail: kyeva.ho@polyu.edu.hk
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
25 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Oui
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
- have smoking in the previous 30 days.
- be above 25 years old
- able to speak Cantonese and read Chinese
Exclusion Criteria:
- who are receiving current smoking cessation services
- report psychological disorders
- at risk of suicide
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Autre: Mixed and Match
Participants can choose to receive their own smoking cessation treatment options from our menu.
|
Participants will receive a brief 15-minute counselling session based on the 5A's' and '5R's' models by our trained research assistant.
Participants will be able to choose their smoking cessation treatment options from our menu.
|
Autre: Control
Participants will receive a self-help quitting leaflet
|
Participants in the control group will receive a self-help quitting leaflet issued by the TACO
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Self-reported abstinence at 6-month follow-up
Délai: At 6-month follow-up
|
participants will be asked about their self-reported abstinence in the past 7 and 30 days
|
At 6-month follow-up
|
Biochemically validated abstinence
Délai: At 6 months follow-up
|
validate the self-reported abstinence if the level of carbon monoxide in expired air was less than 4 parts per million and saliva cotinine level was less than100 ng/mL in parallel tests
|
At 6 months follow-up
|
Self-efficacy at 6-month follow-up
Délai: At 6-month follow-up
|
Participants will be asked about their self-efficacy in quitting.
The score ranges from 0 to 10. Higher scores represent a higher self-efficacy.
|
At 6-month follow-up
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Screening rate
Délai: at day 1
|
calculated as the number of smokers screened at smoking hotspots by the RA divided by number of smokers available
|
at day 1
|
Eligibility rate
Délai: at day 1
|
calculated by dividing the number of smokers who are eligible by the number who are screened.
|
at day 1
|
Randomization rate
Délai: at day 1
|
calculated by dividing the number of smokers who are randomized into intervention and control groups by those who provide consent.
|
at day 1
|
Attendance rate
Délai: Immediately after the training workshop
|
calculated by dividing the number of smokers who complete the intervention by those who are randomized.
|
Immediately after the training workshop
|
Retention rate at 1-week follow-up
Délai: At 1-week follow-up
|
calculated by dividing the number of smokers who remain in the study by those who are randomized
|
At 1-week follow-up
|
Retention rate at 1-month follow-up
Délai: At 1-month follow-up
|
calculated by dividing the number of smokers who remain in the study by those who are randomized
|
At 1-month follow-up
|
Retention rate at 6-month follow-up
Délai: At 6-month follow-up
|
calculated by dividing the number of smokers who remain in the study by those who are randomized
|
At 6-month follow-up
|
Retention rate at 3-month follow-up
Délai: At 3-month follow-up
|
calculated by dividing the number of smokers who remain in the study by those who are randomized
|
At 3-month follow-up
|
Adherence to intervention protocol at 1-week follow-up
Délai: At 1-week follow-up
|
calculated by dividing the number of smokers who follow and practice the chosen treatment options by those who are randomized
|
At 1-week follow-up
|
Adherence to intervention protocol at 1-month follow-up
Délai: At 1-month follow-up
|
calculated by dividing the number of smokers who follow and practice the chosen treatment options by those who are randomized
|
At 1-month follow-up
|
Adherence to intervention protocol at 3-month follow-up
Délai: At 3-month follow-up
|
calculated by dividing the number of smokers who follow and practice the chosen treatment options by those who are randomized
|
At 3-month follow-up
|
Adherence to intervention protocol at 6-month follow-up
Délai: At 6-month follow-up
|
calculated by dividing the number of smokers who follow and practice the chosen treatment options by those who are randomized
|
At 6-month follow-up
|
Complete rate at 1-week follow-up
Délai: At 1-week follow-up
|
calculated by dividing the number of smokers who returned questionnaires by the number of questionnaires distributed
|
At 1-week follow-up
|
Complete rate at 1-month follow-up
Délai: At 1-month follow-up
|
calculated by dividing the number of smokers who returned questionnaires by the number of questionnaires distributed
|
At 1-month follow-up
|
Complete rate at 3-month follow-up
Délai: At 3-month follow-up
|
calculated by dividing the number of smokers who returned questionnaires by the number of questionnaires distributed
|
At 3-month follow-up
|
Complete rate at 6-month follow-up
Délai: At 6-month follow-up
|
calculated by dividing the number of smokers who returned questionnaires by the number of questionnaires distributed
|
At 6-month follow-up
|
Missing data at 1-week follow-up
Délai: At 1-week follow-up
|
calculated as the percentage of missing values in the dataset
|
At 1-week follow-up
|
Missing data at 1-month follow-up
Délai: At 1-month follow-up
|
calculated as the percentage of missing values in the dataset
|
At 1-month follow-up
|
Missing data at 3-month follow-up
Délai: At 3-month follow-up
|
calculated as the percentage of missing values in the dataset
|
At 3-month follow-up
|
Missing data at 6-month follow-up
Délai: At 6-month follow-up
|
calculated as the percentage of missing values in the dataset
|
At 6-month follow-up
|
Adverse events at 6-month follow-up
Délai: At 6-month follow-up
|
Participants will report any unfavorable and unintended events
|
At 6-month follow-up
|
Adverse events at 1-week follow-up
Délai: At 1-week follow-up
|
Participants will report any unfavorable and unintended events
|
At 1-week follow-up
|
Adverse events at 1-month follow-up
Délai: At 1-month follow-up
|
Participants will report any unfavorable and unintended events
|
At 1-month follow-up
|
Adverse events at 3-month follow-up
Délai: At 3-month follow-up
|
Participants will report any unfavorable and unintended events
|
At 3-month follow-up
|
Self-reported abstinence at 1-week follow-up
Délai: At 1-week follow-up
|
Participants will be asked about their self-reported abstinence in the past 7 and 30 days
|
At 1-week follow-up
|
Self-reported abstinence at 1-month follow-up
Délai: At 1-month follow-up
|
participants will be asked about their self-reported abstinence in the past 7 and 30 days
|
At 1-month follow-up
|
Self-reported abstinence at 3-month follow-up
Délai: At 3-month follow-up
|
participants will be asked about their self-reported abstinence in the past 7 and 30 days
|
At 3-month follow-up
|
Self-efficacy at 1-week follow-up
Délai: at 1-week follow-up
|
Participants will be asked about their self-efficacy in quitting.
The score ranges from 0 to 10. Higher scores represent a higher self-efficacy.
|
at 1-week follow-up
|
Self-efficacy at 1-month follow-up
Délai: at 1-month follow-up
|
Participants will be asked about their self-efficacy in quitting.
The score ranges from 0 to 10. Higher scores represent a higher self-efficacy.
|
at 1-month follow-up
|
Self-efficacy at 3-month follow-up
Délai: at 3-month follow-up
|
Participants will be asked about their self-efficacy in quitting.
The score ranges from 0 to 10. Higher scores represent a higher self-efficacy.
|
at 3-month follow-up
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Katherine Lam, PhD, The Hong Kong Polytechnic University
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Anticipé)
1 juillet 2022
Achèvement primaire (Anticipé)
31 décembre 2023
Achèvement de l'étude (Anticipé)
31 décembre 2023
Dates d'inscription aux études
Première soumission
18 mai 2021
Première soumission répondant aux critères de contrôle qualité
22 mars 2022
Première publication (Réel)
28 mars 2022
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
28 mars 2022
Dernière mise à jour soumise répondant aux critères de contrôle qualité
22 mars 2022
Dernière vérification
1 mars 2022
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- SDTM-adult
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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