Randomized Controlled Trial for Smartphone-based Smoking Cessation Program – QuitSure
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- IIT BOMBAY
- 入组人数
- 500
- 试验地点
- 6
- 主要终点
- cessation of smoking.
研究概览
简要总结
| The proposed topic of research: Randomized Controlled Trial for Smartphone-based Smoking Cessation Program – QuitSure |
The objective of the proposed research:
A. To assess the impact of the QuitSure program on short-term and long-term smoking cessation.
B. To determine the level of engagement with the QuitSure smartphone app and
C. To assess the feasibility of the QuitSure program.
Background of the present study: Tobacco smoking remains one of the leading causes of preventable death worldwide. The most effective tobacco cessation programs require personalized human intervention combined with costly pharmaceutical supplementation, making them unaffordable and/or inaccessible to most tobacco users. Thus, digital interventions, delivered through smartphones, offer a promising alternative to these traditional methods. We would like to understand whether text and video-based content, delivered via a smartphone application, with minimal to zero human intervention, can be used to reverse the psychological dependence on nicotine (via smoking or vaping) at scale. To answer this, we propose to conduct a randomized controlled trial of the QuitSure smartphone-app-based tobacco cessation program.
Methodology: A two-arm, single-blinded, randomized controlled trial design on adult everyday smokers (at least 1 cigarette per day on average and have smoked at least 100 cigarettes). Eligible participants will be randomly assigned to either do the QuitSure program [the IG] or will simply be given brief advice to quit smoking [the CG]. Both point prevalence (PPA) abstinence and prolonged abstinence (PA) outcomes will be recorded via self-reporting via phone, online, or in-person at the 7-day, 30-day, 3-month, and 6-month time points post the quit date (in the case of the IG) or post the quit date defined in by the CG. At the 30-day and 6- month time points we will also biochemically verify self-reported data by testing saliva cotinine (non-invasive test) in the participants.
Expected outcome: We expect the Quitsure program to be efficacious and feasible for both short-term and long-term cessation of smoking
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •(i) Smokes at least 1 cigarette per day on average and has smoked at least 100 cigarettes till date.
- •(ii) Agrees to participate in a smoking cessation treatment program with written informed consent (iii) Must be an adult over 18 years of age (iv) Are, at minimum, proficient in the written and spoken English Language (v) Must be an everyday smoker: Should currently smoke 01 (one) or more cigarettes per day on an average (indicating sufficient dependence on nicotine) and have smoked at least 100 cigarettes (indicating sufficient exposure of the body to nicotine) on a regular basis.
- •(vi) Have daily access to an Android or iOS smartphone.
- •(vii) Salivary cotinine test positive on the first visit.
- •(viii) Can use a smartphone without difficulty.
- •(ix) Rinsed mouth thoroughly with water 10 minutes before sample is collected.
- •(x) Inclusion criteria for controls: Age and gender matched controls.
排除标准
- •(i) Has already quit smoking and is currently not smoking.
- •(ii) If a doctor has advised the participant not to quit cold-turkey.
- •(iii) History of severe mental illness/ psychiatric illness or under current treatment for psychiatric illness such as schizophrenia or other primary psychotic disorders, BPAD, catatonia, OCD, dissociative disorders, eating disorders, personality disorders.
- •(iv) Unable to attend follow-up clinic visits during the study period.
- •(v) Started taking a smoking cessation medication within 1 year before the registration.
- •(vi) Planned to use any smoking cessation aids and/or to participate in any kind of smoking-cessation activities (not limited to smoking cessation therapy) outside of the trial.
- •(vii) Consumed a major meal within 60 minutes before the test.
- •(viii) Consumed alcohol within 12 hours before the test.
- •(ix) Consumed foods like broccoli, cabbage, mustard, garlic, radishes, almonds and horseradish within 12 hours.
- •(x) Persons working with metal, the related occupations include electroplaters and people who refine precious metals.
- •(xi) Tobacco workers.
结局指标
主要结局
cessation of smoking.
时间窗: after 4 weeks and 24 weeks.
次要结局
- Any form of nicotine and / or smokeless tobacco consumption.(06 months and 12 months.)