Smoking Cessation Clinical Trial
— STEADES-2Official title:
An Innovation Involving Self-Surveillance and Serious Gaming to Increase Smoking Quit Rate: Protocol for a Randomized Controlled Trial
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.
Status | Not yet recruiting |
Enrollment | 40 |
Est. completion date | December 2021 |
Est. primary completion date | December 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 21 Years to 100 Years |
Eligibility | Inclusion Criteria: 1. Subjects who smoke at least one cigarette per day 2. Current user of smartphone which STEADES mobile application can be downloaded 3. Willingness to use the STEADES-2 device to monitor the eCO at least once daily for smoking cessation 4. Willingness to engage the virtual coach at least once weekly during the study period 5. Willingness to play the serious games minimally once daily 6. Ability to provide informed consent and to return the STEADES-2 device to the study team upon completion of the study (for intervention group) Exclusion Criteria: 1. Non-smoker or ex-smoker who has not smoked any cigarette for the past one month 2. Current user of mobile phone which lacks the function to download mobile application 3. 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) 4. Any disability which renders the smoker incapable of providing informed consent independently |
Country | Name | City | State |
---|---|---|---|
Singapore | Ngiap Chuan Tan | Singapore |
Lead Sponsor | Collaborator |
---|---|
SingHealth Polyclinics | ITE College West, Taggle Pte Ltd |
Singapore,
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* Note: There are 11 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 |
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