Efficacy of Smartphone App for Smoking Cessation in China

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

Tracking Information

• First Submitted Date: June 4, 2020
• First Posted Date: June 9, 2020
• Last Update Posted Date: January 24, 2022
• Actual Study Start Date: February 23, 2021
• Estimated Primary Completion Date: August 30, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Efficacy of Smartphone App for Smoking Cessation in China
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Treatment

Condition

• Cigarette Smoking
• Smartphone App-based Smoking Cessation

Intervention

Behavioral: smartphone app for smoking cessation

Paticipants will receive 12-week app-based smoking cessation intervention with follow-up to 26 weeks.

Study Arms

• 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.

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: June 5, 2020): 1200
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: February 28, 2023
• Estimated Primary Completion Date: August 30, 2022 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 25 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Yanhui Liao, MD; 8615116225099; tangliaoyanhui@163.com

• Listed Location Countries: China

Administrative Information

• NCT Number: NCT04421170
• Other Study ID Numbers: 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

• 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: Sir Run Run Shaw Hospital
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• 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