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Efficacy of Smartphone App for Smoking Cessation in China

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ClinicalTrials.gov Identifier: NCT04421170
Recruitment Status : Recruiting
First Posted : June 9, 2020
Last Update Posted : January 24, 2022
Sponsor:
Information provided by (Responsible Party):
Yanhui Liao, Sir Run Run Shaw Hospital

Tracking Information
First Submitted Date  ICMJE June 4, 2020
First Posted Date  ICMJE June 9, 2020
Last Update Posted Date January 24, 2022
Actual Study Start Date  ICMJE February 23, 2021
Estimated Primary Completion Date August 30, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 5, 2020)
Biologically verified continuously smoking abstinence at week 26 [ Time Frame: 26 weeks ]
Participants in this study will be considered to be biologically verified continuously smoking abstinence if they report smoking no more than 5 cigarettes since the quit date and have an expired carbon monoxide concentration of less than 10 ppm (for local participants who will be able to go to the PI affiliated hospital) or a urine cotinine cutoff point of 200 ng/ml (cotinine urine dipsticks will be mailed to each participant's address, and test will be confirmed by video call and by family members) at week 26 (6 months) after quit date. This abstinence has been applied by the Society for Research on Nicotine and Tobacco (SRNT) (Hughes, Keely et al. 2003) and the 'Russell Standard' (West, Hajek et al. 2005).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 5, 2020)
  • 7-day point prevalence smoking abstinence [ Time Frame: 26 weeks ]
    7-day Point prevalence of smoking abstinence: not even a puff of smoke, for the last seven consecutive days, at 1, 2, 3, 4, 8, 12, 16, 20 and 26 weeks.
  • Self-reported continuous smoking abstinence [ Time Frame: 26 weeks ]
    Self-reported continuous smoking abstinence: a self-report of smoking ≤ 5 cigarettes from the past 1, 2, 3, 4, 8, 12, 16, 20 and 26 weeks.
  • Reductions in number of cigarettes smoked per day [ Time Frame: 26 weeks ]
    Reductions in number of cigarettes smoked per day: will be assessed by comparing the number of cigarettes smoked per day at baseline and at 26 weeks. Cigarettes smoked per day: number of cigarettes smoked per day within seven days or the approximate total number of smoked cigarettes within seven days if not smoked daily.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy of Smartphone App for Smoking Cessation in China
Official Title  ICMJE Efficacy of Cognitive Behavioral Therapy-based Smartphone App for Smoking Cessation in China: a Study Protocol of a Randomized Controlled Trial
Brief Summary This study aims to evaluate the efficacy of cognitive behavioral therapy (CBT)-based cigarette smoking cessation smartphone app for treatment seeking smokers in China.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Cigarette Smoking
  • Smartphone App-based Smoking Cessation
Intervention  ICMJE Behavioral: smartphone app for smoking cessation
Paticipants will receive 12-week app-based smoking cessation intervention with follow-up to 26 weeks.
Study Arms  ICMJE
  • Experimental: Intervention Group
    Participants from the intervention group will receive CBT based smoking cessation. It provides both mandatory information of evidence-based and guideline-based smoking cessation interventions, and optional information about quitting benefits, tips for quitting et al. The app will be available for the participants in the intervention group until 26-week post-quit date follow-up. After this period, the app will automatically stop the data collection, but they can continue to use it if they want. As the participants progressed through the study, smoking cessation related information will be gradually reduced until 12 weeks after quit date, and follow-up messages will be sent at 16, 20 and 26 weeks after quit date. Participants from intervention group can also seek for help at any time by text or WeChat, or make a phone call.
    Intervention: Behavioral: smartphone app for smoking cessation
  • No Intervention: Control group
    Participants from the control group will only receive information of thanking them for being in the study and reminding them of the time until their free month at the end of follow up. In order to measure the outcomes between two groups, continuous smoking abstinence, point prevalence of abstinence, how many cigarettes per day during the last week if they are still smoking will be checked at week 1, 2, 3, 4, 8, 12, 16, 20 and 26 points after quit date by ePRO software. Biochemically verified continuously abstinence will also be checked if they have reported continuous smoking abstinence at week 26 points after quit date.
Publications * Liao Y, Tang J. Efficacy of cognitive behavioural therapy-based smartphone app for smoking cessation in China: a study protocol of a randomised controlled trial. BMJ Open. 2021 Jan 13;11(1):e041985. doi: 10.1136/bmjopen-2020-041985.

*   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 5, 2020)
1200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 28, 2023
Estimated Primary Completion Date August 30, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Cigarette smokers (smoked more than 100 cigarettes in their lifetime, and currently smoke five or more cigarettes a day)
  2. 25 years of age or older
  3. Being able to read and write in Chinese
  4. Owning a smartphone
  5. Have experience of using apps
  6. Expressing an interest in quitting smoking within the next month
  7. Willing to provide informed consent to participate in the study

Exclusion Criteria:

  1. Nonsmokers
  2. Only use electronic cigarettes
  3. Smokers without attempts to quit smoking
  4. Participants with severe mental illness
  5. Participants who had already started their quit attempt or using any smoking cessation treatment at the time of registration
  6. Unable to use smartphone and apps
  7. Unable to read and write in Chinese
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 25 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Yanhui Liao, MD 8615116225099 tangliaoyanhui@163.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04421170
Other Study ID Numbers  ICMJE 20200129-33
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: Yes
Plan Description: All collected IPD, all IPD that underlie results in a publication.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Supporting Materials: Analytic Code
Time Frame: Starting 1 month after publication.
Access Criteria: Yanhui Liao will review requests and criteria for reviewing requests
Current Responsible Party Yanhui Liao, Sir Run Run Shaw Hospital
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Sir Run Run Shaw Hospital
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Yanhui Liao, MD Department of Psychiatry, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
PRS Account Sir Run Run Shaw Hospital
Verification Date January 2022

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