An Innovation Involving Self-Surveillance and Serious Gaming to Increase Smoking Quit Rate: Protocol for a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Percentage of subjects with Partial Smoking Cessation in then intervention and control arms
研究概览
简要总结
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.
详细描述
This overarching aim of this pilot randomized controlled trial is to determine the feasibility of implementing the STEADES system (device and app) in smokers and to compare its effectiveness in increasing their smoking quit rate between the intervention and control groups. Feasibility is demonstrated by quantifying the self-surveillance, serious gaming and engagement of the virtual coaches in the STEADES-2 system. Thus the feasibility is evaluated by the utility rate of the STEADES-2 device by the smokers, transmission rate of the eCO data and frequency of interaction with their virtual coach and gamification rate.
Aims The study aims to determine the proportion of smokers with total abstinence of smoking in the STEADES-2 intervention arm compared to those in the control arm at the end of 12 weeks after study enrolment.
Hypothesis The proportion of smokers with total smoking abstinence in the intervention arm will be 50% higher than those in the control arm at the end of 12 weeks from the time of study recruitment. The total smoking abstinence is defined by both the eCO measurement (0-1pmm) from the STEADES-2 device and the negative result based on the cotinine test kit at 12 weeks.
Method The study is a pilot randomized controlled trial in ambulatory setting at public primary care clinics (polyclinics) in a densely populated, urbanised community in Singapore.
Study sites:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- •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
结局指标
主要结局
Percentage of subjects with Partial Smoking Cessation in then intervention and control arms
时间窗: 12 weeks
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)
Percentage of subjects who fail Smoking Cessation in the intervention and control arms
时间窗: 12 weeks
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)
Percentage of subjects with complete smoking cessation in the intervention and control arms
时间窗: 12 weeks
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)
次要结局
未报告次要终点
研究者
Tan Ngiap Chuan
Director- Research
SingHealth Polyclinics