Feasibility, Acceptability, and Preliminary Effectiveness of a WeChat Quit Coach Smoking Cessation Intervention: A Pilot, Open-labeled, Randomized Controlled Trial Among Chinese Immigrant Smokers
WeChat Quit Coach
+ Optional Nicotine Replacement Therapy (NRT) Patches or Lozenges
+ Leaflet
Autre étude
Résumé
Date de début de l'étude : 10 février 2022
Date à laquelle le premier participant a commencé l'étude.The study team will develop and assess the feasibility and acceptability of a WeChat-based peer-group mobile messaging smoking cessation intervention targeting Chinese immigrant smokers in New York City (NYC). For Aim 1, the study team will develop a message library for the WeChat Quit Coach smoking cessation program and conduct in-depth interviews with 20 Chinese immigrant smokers in person to assess content relevance. For Aim 2, a two-arm, open-labeled, pilot randomized controlled trial (RCT) will be conducted to test the feasibility and acceptability of the WeChat Quit Coach intervention among 60 Chinese immigrant smokers. Participants will be randomized to intervention (n=40) or control group (n=20). Participants in the intervention group will receive a 6-week WeChat Quit Coach intervention through WeChat private group. Participants in the control group will receive a leaflet with information about existing smoking cessation programs that focus on Chinese American smokers. All the 60 participants will be offered a 4-week supple of nicotine replacement therapy (NRT) patches and/or lozenges. Participants will complete a baseline in-person survey at enrollment, a 6-week follow-up phone survey immediately after the intervention, and a 6-month follow-up phone survey. Biochemical test (exhaled carbon monoxide test) will be conducted to confirm abstinence among those who report no smoking in past 7-day at 6-week and 6-month follow-up surveys. Post-test in-depth interviews will be conducted with at least 20 participants in person from the intervention group at 6-week follow-up to obtain more information about the usability and perceptions about the WeChat Quit Coach program. For Aim 3, the investigators will conduct an open-labeled, 3-arm pilot RCT to test the preliminary effectiveness of the WeChat Quit Coach intervention with 90 Chinese immigrant smokers. Participants will be randomized to one of the three groups, including a 6-week intervention group A (IA; n = 30), a 12-week intervention group B (IB; n = 30), and a control group (n = 30). Participants in the intervention groups will either receive a 6-week (IA) or 12-week (IB) WeChat Quit Coach intervention through WeChat private groups. Participants in the control group will receive a leaflet with information of existing smoking cessation programs targeting Chinese American smokers. All 90 participants will be offered a 4-week free supply of NRT patches and/or lozenges. Participants will complete a baseline phone survey at enrollment, 12-week and 6-month follow-up phone surveys. A remote biochemical validation (saliva cotinine test) will be conducted at 12-week and 6-month follow-up to confirm smoking abstinence among those who self-report no smoking in the past 7 days. Post-test in-depth phone interviews will be conducted with up to 30 intervention participants to obtain more information about their perceptions and experience with the WeChat Quit Coach program.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.150 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Autre
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.De 18 à 80 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains non autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Critères
Inclusion Criteria: Aim 2: * Age 18-80 years * Chinese immigrant * Have smoked at least 100 cigarettes in a lifetime * Smoke ≥3 days per week * Be somewhat interested in quitting smoking * Has a Smartphone * Current WeChat user who uses WeChat on ≥3 days per week * Live in NYC * Can read and speak Chinese * Be able to provide consent Aim 3: * Age 18 years or above * Chinese immigrant * Have smoked at least 100 cigarettes in a lifetime * Smoke ≥1 days per week * Current WeChat user who uses WeChat on ≥3 days per week * Can read and speak Chinese Exclusion Criteria: Aim 2: * Current participation in other smoking cessation treatment program(s) * Be pregnant or breastfeeding Aim 3: * Current participation in other smoking cessation treatment program(s) * Be pregnant or breastfeeding * Having a household member who has enrolled in this study
Plan de l'étude
Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.3 groupes d'intervention sont désignés dans cette étude
Cette étude ne comporte pas de groupe placebo.
Groupes de traitement
Groupe I
ExpérimentalGroupe II
ExpérimentalGroupe III
Comparateur actifObjectifs de l'étude
Objectifs principaux
Objectifs secondaires
Centres d'étude
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