Effectiveness of a Chat Bot for Smoking Cessation: a Pragmatic Trial in Primary Care.

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effectiveness of a Chat Bot for Smoking Cessation: a Pragmatic Trial in Primary Care.

Conditions
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Tobacco Use Cessation

Intervention / Treatment
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* Other: Chat bot
* Other: Usual care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: Communicative barriers. Addiction to other substances. Participation in another cessation program or other clinical trial during the study period.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: N = 460 smokers (230 in each arm), who will be recruited before randomization. Interventions: Intervention group: Use of an evidence-based chat bot for smoking cessation. Control group: Usual care (Madrid Health System Portfolio).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Use of an evidence-based chat bot for smoking cessation | Other: Chat bot<br>* Patients in intervention arm will use an evidence-based chat bot as an aid for smoking cessation<br>* Other names: Intervention arm;|
| Active Comparator: Control<br>Usual care (Madrid Health System Portfolio). | Other: Usual care<br>* Usual care given by their usual general practitioners and nurses of primary care health centres, as defined in Public Health System Portfolio.<br>* Other names: Active comparator arm;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Continuous tobacco abstinence at six months biochemically validated | 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 | Six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Continuous tobacco abstinence at six months referred by patient | Patient declares to have smoked less than five cigarettes in the last six months | Six months | 
| Descriptive improvement in patient´s quality of life | EuroQol 5D-5L questionary score descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. Patient is asked to indicate health state by ticking the box next to the most appropriate statement in each dimension. This results in a 1-digit number that expresses the level selected for that dimension. Digits can be combined into a 5-digit number that describes the patient's health state. | Six months | 
| Sujective improvement in patient´s quality of life | EuroQol 5D-5L questionary score visual analogue scale (EQ VAS). EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. Can be used as a quantitative measure of health outcome that reflect the patient's own judgement. | Six months | 
| QALYs | Quality-adjusted life years | Six months | 
| Number of therapeutic contacts | Number of contacts (therapist-patient or bot-patient) during the therapeutic process | Six months | 
| Time spent in therapy | Total amount of time spent (in minutes) during the therapeutic process | Six months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tobacco, cessation, medical apps for smartphones