Effectiveness of a Chat Bot for Smoking Cessation: a Pragmatic Trial in Primary Care.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 542
- 试验地点
- 2
- 主要终点
- Continuous tobacco abstinence at six months biochemically validated
研究概览
简要总结
This study aims to evaluate the effectiveness of an intervention to help people to quit smoking throughout an chat bot compared with usual assistance to increase long-term rates of nicotine abstinence in smoking outpatients with biochemical validation at 6 months.
Half of participants(control group) will receive usual care by their usual general practitioners and nurses, and the other half (intervention group) will use an evidence-based chat bot specifically designed to help people quit smoking.
详细描述
An array of interventions have been shown to be both cost-effective and efficacious in helping patients quit smoking and so are included in usual care given by general practitioners and nurses. However, in the primary care setting, this sort of interventions are less common than they should be, due to many circunstances, and solutions must be found due to the huge dimensions of tobacco use challenge.
On the other hand,new kinds of information tecnology give a chance to intervene with less costs and more specific tools. Actually, there are a lot of mobile apps and other devices designed to help people to improve their health in many ways, but without scientific evidence of their effects.
This is a pragmatic, randomised, controled and multicentric clinical trial that tries to evaluate in general population the effectiveness of a chat bot that incorporates evidence based interventions and interacts by a text application instaled in patients mobile phone (intervention group).
Investigators have decided to compare with usual care delivered by the usual general practisioners and nurses of Spanish Public Health Centres, because this interventions have shown their effectiveness (control group).
Efficiency and impact on quality of life will also be compared on both groups.
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
盲法说明
Intervention can´t be masked. We will objectify primary outcome by biochemistry validation, and statistician conducting the analysis will not know to which study arm a given patient has been assigned.
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
- •18 years or more
- •Smoked more than one cigarette per day last month.
- •Accepts help to quit smoking next month.
- •Owns a mobile phone with the ability to install a messaging application.
- •Does not anticipate changing address in the next 6 months.
- •Understands spoken and written spanish language.
- •Accepts to participate and signs the informed consent.
排除标准
- •Communicative barriers.
- •Addiction to other substances.
- •Participation in another cessation program or other clinical trial during the study period.
结局指标
主要结局
Continuous tobacco abstinence at six months biochemically validated
时间窗: Six months
Patient declares to have smoked less than five cigarettes in the last six months and have less than 10 parts per million (ppm) of carbon monoxide in exhaled air measured by a Pico+TM Smokerlyzer® cooximeter
次要结局
- Continuous tobacco abstinence at six months referred by patient(Six months)
- Number of therapeutic contacts(Six months)
- Time spent in therapy(Six months)
- Descriptive improvement in patient´s quality of life(Six months)
- Sujective improvement in patient´s quality of life(Six months)
- QALYs(Six months)
研究者
Eduardo Olano
Phd in Medicine. Family and Community Medicine Specialist
Gerencia de Atención Primaria, Madrid