An Innovation to Increase Smoking Quit Rate

NCT04630340 | Unknown

• 1 other identifier: 2020/2762
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

An Innovation involving Self-Surveillance and Serious Gaming to Increase Smoking Quit rate: Protocol for a randomized controlled trial. Abstract Introduction and study aims Smoking is a health hazard associated with cancer, vascular and lung diseases. Current methods to manage smoking cessation have limited success. A recent systematic review suggests increase in smoking cessation potential via serious gaming to attain desirable healthcare outcomes. Outcomes are limited in these studies to demonstrate, quantify, and understand these interventions. The investigators have demonstrated feasibility of a portable device ("STEADES-1") which allows smokers to measure their exhaled-breath carbon monoxide (eCO) levels, related to their cigarette-smoking intensities. They can relay the eCO measurements via smart-phone applications (app) to their virtual coach to report their smoking cessation progress. The investigators have created an enhanced STEADES-2 system, which incorporates gamification using the eCO data as game element and allows anonymized smokers to compete with each other for the game rewards. It has additional authentication functions and embeds an e-coaching program by trained healthcare professionals. Methods and analysis This pilot randomized controlled trial aims to evaluate the feasibility and outcomes of the STEADES-2 system in increasing smoking quit rate. The former includes assessing the smokers to monitor their eCO levels; leverage on telesupport via the e-Coaching to raise their motivation; reduce relapse tendencies by playing serious games with fellow smokers. The investigators postulate that the smoking quit rate in smokers in the STEADES-2 intervention group will be higher by 50% than the controls over 12 weeks. This trial will randomly select 20 smokers each into the intervention group and the control group. Smokers in both groups will be compared in terms of complete abstinence from cigarettes as the primary outcome at 12 weeks post-enrolment. Ethics and dissemination The Institutional Review Board approves the study. The results will be disseminated via conferences and publications.

Conditions

Smoking Cessation

Keywords

carbon monoxide; coach; surveillance; serious games

Outcome Measures

Primary Outcomes (3)

• Percentage of subjects with complete smoking cessation in the intervention and control arms

  Number of subjects with exhaled carbon monoxide level of 0 ppm and negative cotinine test divided by the total number of the enrolled subjects in each arm x100 (in percentage)

  12 weeks

• Percentage of subjects with Partial Smoking Cessation in then intervention and control arms

  Number of subjects with exhaled carbon monoxide level above 1ppm or positive cotinine test divided by the total number of enrolled subjects in each arm x100 (in percentage)

  12 weeks

• Percentage of subjects who fail Smoking Cessation in the intervention and control arms

  Number of subjects with exhaled carbon monoxide level above 1ppm and positive cotinine test Divided by the total number of enrolled subjects in each arm x 100 (In percentage)

  12 weeks

Study Arms (2)

STEADES-2 (Intervention) arm

ACTIVE COMPARATOR

Subjects in the intervention arm will fill up the questionnaire embedded in the STEADES app and be inducted to the use of STEADES-2 device by the CRC. The CRC will assist to download the STEADES app into the subject's smartphone; demonstrate the use of the app and the procedure for the serious games; and linkage to the virtual coach. The subject will use the STEADES-2 device to assess their smoking status and play the game according to the stipulations in the protocol. The STEADES-2 app provides a portal for the subject to interact with the assigned virtual coach and for motivation messages to be delivered to them. The primary outcome is total smoking cessation as measured by 1. exhaled breath carbon monoxide using the STEADES-2 device and 2. urine cotinine level which indicates the nicotine from the cigarette smoking The secondary outcome is the score using the System Usability Scale (SUS) to assess the use and experience in using the STEADES-2 system

Device: STEADES-2

Usual Care

NO INTERVENTION

In the control arm, the subjects will be enrolled into the existing smoking cessation program at the respective polyclinic, which covers smoking cessation advice, together with an exhaled breath analyzed using a commercially available eCO measurement device by a trained nurse counsellor. They will complete a questionnaire and their smoking status will be re-assessed at 12 weeks after their enrolment. The primary outcome is total smoking cessation at the end of the study: 1. as measured by the exhaled breath carbon monoxide level determined by the STEADES-2 device and 2. urine cotinine levels which is a marker of nicotine level from smoking

Interventions

STEADES-2 DEVICE

In this arm, the subjects will use a novel exhaled breath carbon monoxide measurement instrument (STEADES-2) for self surveillance of their smoking status. In addition, the subjects will download the STEADES-2 mobile phone application to pay serious games relating to smoking cessation, receive push-though motivational messages and e-coaching from trained healthcare professionals.

STEADES-2 (Intervention) arm

Eligibility Criteria

• Age: 21 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects who smoke at least one cigarette per day
• Current user of smartphone which STEADES mobile application can be downloaded
• Willingness to use the STEADES-2 device to monitor the eCO at least once daily for smoking cessation
• Willingness to engage the virtual coach at least once weekly during the study period
• Willingness to play the serious games minimally once daily
• Ability to provide informed consent and to return the STEADES-2 device to the study team upon completion of the study (for intervention group)

You may not qualify if:

• Non-smoker or ex-smoker who has not smoked any cigarette for the past one month
• Current user of mobile phone which lacks the function to download mobile application
• Inability to commit to the study completion or return of the STEADES-2 device at the end of the study (for subjects randomized to the intervention group)
• Any disability which renders the smoker incapable of providing informed consent independently

Sponsors & Collaborators

• SingHealth Polyclinics: lead
• Taggle Pte Ltd: collaborator
• ITE College West: collaborator

Study Sites (1)

Ngiap Chuan Tan

Singapore, 150167, Singapore

Location

Related Publications (11)

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  PMID: 23176746 BACKGROUND

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  PMID: 26966391 BACKGROUND

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  PMID: 11841136 BACKGROUND

• Buchhalter AR, Fant RV, Henningfield JE. Novel pharmacological approaches for treating tobacco dependence and withdrawal: current status. Drugs. 2008;68(8):1067-88. doi: 10.2165/00003495-200868080-00005.

  PMID: 18484799 BACKGROUND

• Kenny PJ, Markou A. Neurobiology of the nicotine withdrawal syndrome. Pharmacol Biochem Behav. 2001 Dec;70(4):531-49. doi: 10.1016/s0091-3057(01)00651-7.

  PMID: 11796152 BACKGROUND

• Daoud N, Jung YE, Sheikh Muhammad A, Weinstein R, Qaadny A, Ghattas F, Khatib M, Grotto I. Facilitators and barriers to smoking cessation among minority men using the behavioral-ecological model and Behavior Change Wheel: A concept mapping study. PLoS One. 2018 Oct 24;13(10):e0204657. doi: 10.1371/journal.pone.0204657. eCollection 2018.

  PMID: 30356254 BACKGROUND

• Tan JW, Zary N. Diagnostic Markers of User Experience, Play, and Learning for Digital Serious Games: A Conceptual Framework Study. JMIR Serious Games. 2019 Jul 16;7(3):e14620. doi: 10.2196/14620.

  PMID: 31313660 BACKGROUND

• Lu AS, Kharrazi H. A State-of-the-Art Systematic Content Analysis of Games for Health. Games Health J. 2018 Feb;7(1):1-15. doi: 10.1089/g4h.2017.0095. Epub 2018 Jan 2.

  PMID: 29293368 BACKGROUND

• Derksen ME, van Strijp S, Kunst AE, Daams JG, Jaspers MWM, Fransen MP. Serious games for smoking prevention and cessation: A systematic review of game elements and game effects. J Am Med Inform Assoc. 2020 May 1;27(5):818-833. doi: 10.1093/jamia/ocaa013.

  PMID: 32330255 BACKGROUND

• Xi ZX, Spiller K, Gardner EL. Mechanism-based medication development for the treatment of nicotine dependence. Acta Pharmacol Sin. 2009 Jun;30(6):723-39. doi: 10.1038/aps.2009.46. Epub 2009 May 11.

  PMID: 19434058 RESULT

MeSH Terms

Conditions

Smoking Cessation

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Study Officials

• Ngiap Chuan Tan

  SingHealth Polyclinics

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ngiap Chuan Tan, FCFP

CONTACT

63507597; Tan.ngiap.chuan@singhealth.com.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director- Research

Model Details: Randomized Controlled Feasibility Trial

Study Record Dates

• First Submitted: September 14, 2020
• First Posted: November 16, 2020
• Study Start: January 1, 2021
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: November 24, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)