Sevrage Tabagique à l'Aide Des Outils dédiés Selon la Préférence, un Essai randomisé contrôlé Pragmatique
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 167
- 试验地点
- 27
- 主要终点
- Smoking abstinence at 6 months after inclusion (yes/no)
研究概览
简要总结
- Objective:
Our study aims to evaluate the effectiveness of the "STOP" (Sevrage Tabagique à l'aide d'Outils dédiés selon la Préférence: Smoking Cessation using preference-based tools) intervention, a preference-based smoking cessation intervention for smokers with low socio-economic position (SEP).
- Methods :
STOP is a randomised, multi-centre, single blinded, intent-to-treat trial. Participating centres include primary care practices (community, municipal or general health clinics), hospital-based facilities, and healthcare institutions specialised in addiction treatment. Smokers with low SEP will be randomised into either the intervention or control group.
Persons randomised to the control group will be accompanied by their health professional according to standard practice.
Participants randomised to the intervention group will receive the same smoking cessation advice, drug (varenicline, champix,..) prescription and support as participants in the control group, but they will also have a choice of being given free Nicotine Replacement Therapy (NRT) (transdermal patch, gum, spray, inhaler, sublingual tablets/lozenges) and/or an electronic cigarette + e-liquid on the spot to aid their quit attempt.
Follow-up appointments will take place at around 7 to 14 days, 1 month, 3 months and 6 months after inclusion, according to the participant and health professional availability.
The main outcome measure of this study will be the 7-day point prevalence tobacco abstinence at 6 months after inclusion (yes/no), defined as self-reported abstinence for at least 7 days, This self-reported abstinence will be validated by measured exhaled carbon monoxide, unless this measurement is unavailable due to the ongoing covid-19 pandemic.
详细描述
This is a randomised, multi-centre, single blinded, intent-to-treat pragmatic trial.
- Recruitment:
Participants will be recruited by physicians in the different study centres starting March 2021. Physicians are therefore asked to present the study to their patients who might be eligible to participate in the study. Posters and flyers inviting smokers who wish to quit to talk to their physician about smoking cessation are also supplied to participating centres.
Physicians can also carry out a pre-inclusion questionnaire over the phone or during a remote consultation, prior to a face to face appointment. However study presentation, recruitment, and baseline measures are will only be done with patients physically present at the study centre.
In some centres (depending on declared need), a research assistant (RA) might help physicians in describing the project to each potential participant. After a presentation of the study objective, a written informed consent (supplementary material) will be asked from eligible patients before proceeding with randomisation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Daily smokers (5≥ cigarettes/day)
- •A low socio-economic position (meaning being unemployed or being a recipient of one of the state programs for low income individuals)
- •Being available for at least 4 appointments over a 6 month period
- •Affiliation to or benefiting from social security or state medical support
排除标准
- •Individuals who do not speak French, or who have cognitive impairments making it impossible to understand study information or a condition that makes it impossible for them to give informed consent.
- •Major citizens protected by law, adults unable to express their consent and subject to a protective measure (guardianship, curatorship, safeguard of justice)
- •Pregnant women or with a pregnancy project, mothers breastfeeding their child(ren).
- •Regular smokers who vape daily (at least once a day).
- •People who at the time of inclusion are already being managed for smoking cessation (whatever treatment: varenicline, electronic cigarette, NRT, hypnosis, acupuncture, psychotherapy, talk groups, etc.).
- •Patients who are already participating in another clinical study (self-reported).
结局指标
主要结局
Smoking abstinence at 6 months after inclusion (yes/no)
时间窗: 6 months after inclusion
Self-reported 7-day point prevalence tobacco abstinence, validated by measured exhaled carbon monoxide, if this measurement is available (depending on the sanitary measures in place due to the ongoing covid-19 pandemic).
次要结局
- Total number of days of abstinence at 6 months(6 months after inclusion)
- Smoking abstinence at 1 and 3 months after inclusion (yes/no)(1 and 3 months after inclusion)
- Number of relapses(3 and 6 months after inclusion)
- The number of cigarettes smoked per day(6 months after inclusion)
- Proportion of participants who have significantly reduced daily smoking(6 months after inclusion)
研究者
Fabienne El-Khoury
Senior researcher, principal investigator
Institut National de la Santé Et de la Recherche Médicale, France