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Boosting Chinese Healthcare Service Providers' Utilization of Smoking Cessation Interventions by 'WeChat WeQuit' Program

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ClinicalTrials.gov Identifier: NCT03556774
Recruitment Status : Recruiting
First Posted : June 14, 2018
Last Update Posted : August 12, 2020
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Yanhui Liao, Sir Run Run Shaw Hospital

Tracking Information
First Submitted Date  ICMJE April 29, 2018
First Posted Date  ICMJE June 14, 2018
Last Update Posted Date August 12, 2020
Actual Study Start Date  ICMJE April 1, 2019
Estimated Primary Completion Date August 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 2, 2018)
The effectiveness of 'WeChat WeQuit' training program. [ Time Frame: 52 weeks ]
The utilization rate (i.e. rate=smokers treated divided by smokers seen) of behavioral and pharmacotherapy interventions by HSP for smoking patients from 8 to 52-week.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 15, 2018)
Prevalence of smoking abstinence [ Time Frame: 24 weeks ]
The proportion of smoking patients with 7-day point prevalence smoking abstinence (not even a puff of smoke, for the last 7 days) at 4, 8, 12, 16, 20 and continuously abstinence assessed at 24-weeks follow-up.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 2, 2018)
Prevalence of smoking abstinence [ Time Frame: 24 weeks ]
The proportion of smoking patients with 7-day point prevalence smoking abstinence (not even a puff of smoke, for the last 7 days) at 4, 8, 12, 16, 20 and continuously abstinence assessed at 6-months follow-up.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Boosting Chinese Healthcare Service Providers' Utilization of Smoking Cessation Interventions by 'WeChat WeQuit' Program
Official Title  ICMJE Boosting Chinese Healthcare Service Providers' Utilization of Behavioral and Pharmacotherapy Interventions for Cigarette Smoking Cessation by 'WeChat WeQuit' Program
Brief Summary In this single-blind, randomized trial, undertaken in China with 8-week interventions and follow-up to 52 weeks, about 2,200 providers will be randomly allocated to the intervention or control group.
Detailed Description

Previous studies have been showed that providing behavioral and pharmacotherapy interventions for cigarette smoking patients was effective but rare among Chinese healthcare service providers. In order to minimize the huge gap between the shortage and demand for smoking cessation training program and smoking cessation service, this 'WeChat WeQuit' smoking cessation training program has been designed to assess whether it will increase Chinese healthcare service providers' utilization of behavioral and pharmacotherapy interventions for cigarette smoking cessation or not.

In this single-blind, randomized trial, about 2200 HSPs will be randomly selected (by randomizeR, https://CRAN.R-project.org/package=randomizeR) to 8-week intervention (behavioral and pharmacotherapy interventions for cigarette smoking patients to help them quit smoking) group or control group that only communicates without any standard smoking cessation practices related messages, and follow-up to 52 weeks. The trial will be carried out in into two phases, the first phase is the pilot study (n=200, 8-week intervention and follow-up to 16 weeks) and the second is the main study (n=2000, 8-week intervention and follow-up to 52 weeks). It is hypothesized that 'WeChat WeQuit' training program will improve Chinese HSPs' utilization of behavioral and pharmacotherapy interventions for cigarette smoking cessation and increase quit rate for smoking patients.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Health Services Research
Condition  ICMJE
  • Smoking Cessation Intervention
  • Smoking Abstinence
Intervention  ICMJE Behavioral: 'WeChat WeQuit' smoking cessation training program
Providing 'WeChat WeQuit' smoking cessation training program for healthcare service providers (HSPs) and assessing their utilization of behavioral and pharmacotherapy interventions for cigarette smoking cessation.
Study Arms  ICMJE
  • Experimental: With smoking cessation training
    Participants who allocate to the intervention group will receive regular smoking cessation training program messages by professional team. One to six messages will be sent per day for 8 weeks. Hand copy of behavioral and pharmacotherapy interventions manual will send to each HSP by mail after randomization. One to three messages will be sent per week until the end of the 1-year follow-up. They will also be encouraged to communicate the experience of using behavioral and pharmacotherapy interventions in their group.
    Intervention: Behavioral: 'WeChat WeQuit' smoking cessation training program
  • No Intervention: Without smoking cessation training
    Control group participants will not receive any smoking cessation messages by professional team. They will receive messages of thanking them for being in the study and reminding them of the time until 52-week follow-up. One to six messages will be sent per week for 8 weeks. They will be encouraged to communicate the experience of helping patients quit smoking in their group.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 2, 2018)
2200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 30, 2021
Estimated Primary Completion Date August 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Chinese-speaking healthcare service providers
  2. Know how to use WeChat
  3. Use WeChat on a daily basis
  4. Willing to provide informed consent to participate in the study -

Exclusion Criteria:

  1. Non-Chinese speakers
  2. Not healthcare service providers
  3. Do not use WeChat
  4. Unwilling to participate in the study -
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Yanhui Liao, MD +8615116225099 tangliaoyanhui@163.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03556774
Other Study ID Numbers  ICMJE 2017S094
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Yanhui Liao, Sir Run Run Shaw Hospital
Study Sponsor  ICMJE Sir Run Run Shaw Hospital
Collaborators  ICMJE Pfizer
Investigators  ICMJE Not Provided
PRS Account Sir Run Run Shaw Hospital
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP