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They also did not find clinical trials, published or in-progress, studying the effectiveness of applications app for mobile phones or tablets, despite their proliferation. The de of the study does not allow for masking the patient to the received treatment. Although it is not a new technology, the recent technical revolution for the interpretation of natural languages, together with the above-mentioned advantages and certain downsides of apps, make chat-bots ideal tools for the purposes of this intervention.

However, to achieve this, a resource backed by scientific evidence and easy to access must be available, such as the tobacco cessation consultations in the British National Health System NHS. The boom in information and communication technologies, like the internet or smartphones, open up new therapeutic perspectives.

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Additionally, the chat-bot incorporates gamification elements games for adults for acquiring new knowledge and skillsincluding a system to earn scores and badges that will provide access to specific information depending on the abstinence period and the needs of the individual. This will take place with different periodicity depending on the quit date and other characteristics of the patient personal choice, type of tobacco use, personal risk situation, prescribed medication, abstinence-related symptoms, and the evolution of coping with abstinence.

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Tobacco use is the main cause of preventable morbidity and mortality in the world, directly ing for five million deaths yearly [ 1 ]. Withdrawn patients will not be excluded from the intention-to-treat analysis. The wide scale and severity of consequences of tobacco use, benefits derived from cessation, low rates of intervention by healthcare professionals, and new opportunities stemming from novel communications technologies in addition to the absence of scientific evidence on its effectiveness and the lack of such tools deed by experts according to the guidelines of the evidence-based clinical practice guidelines are the main factors motivating this project.

In a review about the adequacy of scientific evidence for existing apps to aid people cease smoking in the USA at the time, Abroms et al. The chat is bidirectional, employs multiple media formats, and provides patients with automatic, science-based advice on cognitive-behavioral, motivational, relapse-preventative, and problem-solving techniques. Ina new review [ 16 ] aimed to assess the scientific content of the most used commercial apps in the USA for helping to quit smoking as well as the ones available.

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Such components form an integral part of science-based chats recommended by clinical practice guidelines [ 34 ]. Control group: Usual treatment according to the protocol for tobacco cessation by the Madrid Regional Health Service Main variable: Continuous nicotine withdrawal with free validation carbon monoxide in exhaled air. The second part consists of a visual analog scale VAS ranging from 0 worst possible condition to best possible health condition.

All the information will be recorded on a form created for the trial DCN. Each sex is measured on a 5-level scale. The sample size was calculated based on the outcome of a clinical trial recently conducted of usual clinical care in Madrid public health system that employs a similar definition of continuous abstinence as our study [ 5 ].

Intention-to-treat analysis. This way, they are capable of returning a personalized answer and add a component of user loyalty and usability of the tool [ 1819 ]. This way, all patients will be questioned in person about their tobacco addiction, receive advice from their doctor or nurse to cease smoking, and their willingness to quit will be evaluated. A cost-utility study will be conducted from the perspective of the funder for a 1-year timeframe.

The chat-bot to be evaluated in this trial has been specifically deed by experts in tobacco addiction and artificial intelligence incorporating gamification, cognitive-behavioral, motivational, problem-solving, and relapse-preventing components. The higher the score the better the health condition. To assess the intervention effectiveness in terms of improved adherence to pharmacological treatment for tobacco cessation.

The collaborating healthcare professionals will deliver their data prior to the beginning of the study.

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Many patients respond positively to this proposal, even those who had not considered making an attempt ly to the offer [ 9 ]. The intervention will be organized into several follow-up sessions, either on-line via the chat-bot in which case the patient can access the intervention at their convenience or face-to-face with their healthcare professional in the healthcare center.

It will last one year, six months for recruiting and six months of follow-up. The clinical trial will be pragmatic, randomized, controlled, and multicentric. The evaluated trials were based on interventions mainly using Short Message Service SMSalthough one employed videos, and all were sex in high-income chats with strong policies for tobacco control. From these five questions, a single weighed score is obtained, the so-called utility index.

The chat-bot also offers information about useful medication to quit smoking prescribed by their healthcare professional, and will recommend how to face problems related to the cessation process through advice and relaxation exercises available in different formats, such as video, computer graphics, games, and web links. Each healthcare professional will select patients who smoke, attend the health center for any reason within the recruitment period, and meet the inclusion criteria.

From an ethics perspective, this new type of intervention must be backed by scientific evidence to circumvent pressures from the market or free interests, improve patient safety, and follow the standards of correct practices for clinical interventions. A chat-bot is not a software that needs to be installed in a smartphone or tablet, it respects the privacy of the patient scrupulously, and its learning curve is very short [ 17 ].

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Healthcare professionals are very effective and efficient in their interventions on the smoker, with over threefold success rates of long-term abstinence. The patient can contact the chat-bot at any time, so the and total time of interactions are a priori unknown and will be recorded as secondary variables. The resulting opportunities create a new framework to empower the patient and improve clinical outcomes and health expenditure [ 12 ]. This computer software has a conversation interface that can both answer questions posed by the user in a natural language that commonly used by people with all their variants and ask them questions [ 18 ].

Those who accept will be asked to provide informed written consent.

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Additionally, researchers in charge of the statistical analysis will be blinded to the identity of patients in each treatment group. In case they decline, their gender, age, and reason for declining will be recorded. However, only 1 in 20 chat to quit is supervised by a professional [ 2 ]. In terms of proactive contacts, the patient can choose their timing and frequency. However, this limitation is compensated by the objective measure of the main outcome variable smoking abstinence and the random allocation of patients into study arms.

Intervention group: use of a chat-bot with evidence-based contents to sex quit smoking. The chat-bot will guide them through all the stages of the dishabituation process. : First expected in January Providing science-based evidence on the effectiveness of clinical interventions via information technologies, without the physical presence of a professional, is essential.

We also estimate that this type of intervention will improve the accessibility of patients to an evidence-based treatment. It detected an abstinence rate of 9. De: Randomized, controlled, free, pragmatic clinical trial, with a 6-month follow-up. They will inform patients about the characteristics of the trial and offer them to participate. of consultations and total time in minutes will be recorded in the DCN by the healthcare professional and automatically registered from the chat-bot.

The of abandonments and withdrawals, as well as the reasons for them, will be recorded.

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From this point, subjects will receive encouragement and acknowledgement messages that will be spaced out gradually until six chats of abstinence. We aim to assess whether the effectiveness of the usual intervention in primary care can be improved [ 2 ] by providing healthcare professionals with guidance to help patients accept the offer to quit smoking [ 10 ], so that their motivation to intervene on their patients will increase by decreasing their workload. Metrics details. In terms of free evidence, a systematic review of sex clinical trials on interventions to quit smoking via smartphones [ 13 ] concluded that text messages free the success rates of nicotine abstinence with biochemical validation, showing a risk ratio RR of 2.

The criteria for exclusion are: ificant communication barriers; Addiction to other substances; And participating in another dishabituation program or clinical trial during the study period. The group ased to the chat-bot will be the intervention group and those treated with usual care by their doctor or nurse will be the control group. To obtain this index, the algorithm proposed for Spain has been employed [ 22 ].

We estimate that the intervention to be assessed will double this fig [ 1314 ]. Factors related to these low intervention rates have been identified, and these include lack of training for healthcare professionals and their chat that such interventions are not useful and they lack the time to implement them [ 8 ]. Subjects will download a messaging application on their smartphone for this purpose and will access the chat-bot with an ased personal password. The recruiting participants will record patient data and will be also responsible for their follow-up. Patients who accept the offered help for the month following consultation will be randomly ased to the intervention or control group, where they will receive a personal intervention combining behavioral and pharmacological treatment based on scientific evidence [ 234 ].

Patients ased to the intervention group will use a chat-bot whose script for the smoking cessation process has been developed using contents based on current evidence. Participants will be able to abandon the study at any time and researchers will be able to withdraw any patient under the following circumstances: not meeting the inclusion criteria; Onset of a severe illness during the clinical trial; Sex adverse event, and inability to comply with the study requirements.

To evaluate the cost-utility ratio of the intervention compared to usual practice in primary healthcare.

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On the other hand, patients aspire to play a greater role in their health management and increasingly search for more information in the internet Table 1. Randomized allocation: Subjects will be allocated into the intervention or control group by simple randomization using a software installed in the data collection notebook DCN.

This will be done following the inclusion of patients and data collection in the DCN at the initial visit, which guarantees the masking of the randomization sequence to the professionals recruiting patients. Healthcare centers: Doctors and nurses from 34 healthcare centers in the Madrid Regional Health Service who agreed to participate, amounting to a total of participants. Combining behavioral and pharmacological treatment yields the best [ 234 ]. Various strategies will be implemented in order to increase adherence to the protocol by participating researchers, such us personal follow-up upon achievement of protocol objectives and acknowledgement of their effort via e-mail, and offers of certified training sessions.

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The wide scale and severity of consequences of tobacco use, benefits derived from cessation, low rates of intervention by healthcare professionals, and new opportunities stemming from novel communications technologies are the main factors motivating this project. Specific aspects of the game mechanics score, levels for different abstinence periods and dynamics rewards, acknowledgment will be developed.

In addition to being more efficient, the characteristics of these interventions can improve effectiveness, accessibility, and adherence to treatment. A logistic regression model will be built to adjust for confounding factors.