Clinical trial NCT03445507: Effectiveness of a Chat Bot for Smoking Cessation: a Pragmatic Trial in Primary Care.
Official title: Effectiveness of a Chat Bot for Smoking Cessation: a Pragmatic Trial in Primary Care.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tobacco Use Cessation
Keywords: tobacco
cessation
medical apps for smartphones
Lead sponsor: Gerencia de Atención Primaria, Madrid
Sponsor class: OTHER_GOV
Collaborators: name: Instituto de Salud Carlos III
First posted: 2018-02-26
Enrollment: 542
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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).
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Continuous tobacco abstinence at six months biochemically validated
timeFrame: Six months
Secondary outcomes:
measure: Continuous tobacco abstinence at six months referred by patient
timeFrame: Six months
measure: Descriptive improvement in patient´s quality of life
timeFrame: Six months
measure: Sujective improvement in patient´s quality of life
timeFrame: Six months
measure: QALYs
timeFrame: Six months
measure: Number of therapeutic contacts
timeFrame: Six months
measure: Time spent in therapy
timeFrame: Six months
Other outcomes:
Locations:
city: Alcorcón
country: Spain
facility: Eduardo Olano-Espinosa
state: Madrid
Study officials:
affiliation: GAP Madrid
name: José F Ávila-Tomás, Doctor
role: STUDY_CHAIR
affiliation: Cantabria University
name: Francisco J Ayesta-Ayesta, Doctor
role: STUDY_CHAIR
affiliation: GAP Madrid
name: Francisco J Martínez-Suverbiola, Doctor
role: STUDY_CHAIR
References:
citation: Olano-Espinosa E, Avila-Tomas JF, Minue-Lorenzo C, Matilla-Pardo B, Serrano Serrano ME, Martinez-Suberviola FJ, Gil-Conesa M, Del Cura-Gonzalez I; Dejal@ Group. Effectiveness of a Conversational Chatbot (Dejal@bot) for the Adult Population to Quit Smoking: Pragmatic, Multicenter, Controlled, Randomized Clinical Trial in Primary Care. JMIR Mhealth Uhealth. 2022 Jun 27;10(6):e34273. doi: 10.2196/34273.
citation: Avila-Tomas JF, Olano-Espinosa E, Minue-Lorenzo C, Martinez-Suberbiola FJ, Matilla-Pardo B, Serrano-Serrano ME, Escortell-Mayor E; Group Dej@lo. Effectiveness of a chat-bot for the adult population to quit smoking: protocol of a pragmatic clinical trial in primary care (Dejal@). BMC Med Inform Decis Mak. 2019 Dec 3;19(1):249. doi: 10.1186/s12911-019-0972-z.