Effectiveness of a Conversational Chatbot (Dejal@bot) for the Adult Population to Quit Smoking: Pragmatic, Multicenter, Controlled, Randomized Clinical Trial in Primary Care

Eduardo Olano-Espinosa, Jose Francisco Avila-Tomas, Cesar Minue-Lorenzo, Blanca Matilla-Pardo, María Encarnación Serrano Serrano, F Javier Martinez-Suberviola, Mario Gil-Conesa, Isabel Del Cura-González, Dejal@ Group, L Molina Alameda, C Andrade Rosa, M Espejo Romero, J L Hernandez Garcia, E Perez Perez, J Zambrano Alvarez, F J Sanchez Jimenez, M Garcia Silva, I Martin Gomez, N Puyo Rodriguez, I Sanchez Vazquez, M T Garcia Alegre, C Moral Moraleda, O Perez Gandia, S Hernandez Rodriguez, J Aparicio Velasco, E Cerezo Pascual, C Marin Osorio, E Prieto Villegas, J Rodriguez Donoso, A Rodriguez Huete, F J Romero Blanco, S J Castillo Portales, R Collados Navas, P Gutierrez Sordo, M Sanchez Quejido, C Abad Schilling, M Capitan Jurado, M A Regalado del Valle, H C Alache Zuñiga, B Jaenes Barrios, M Ortiz Sánchez, M L Santiago Hernando, S Arjona Pérez, R Díaz Martin, B Fandiño García, M C Gómez Ortiz, M T López-Martin Aragón, M A Miguel Abanto, M Noguerol Álvarez, S Parra Roman, S Rey Rodríguez, E Aguilar Hurtado, M Aguilera Rubio, A I Carbonero Martín, M Esteban García, C Esteban De la Peña, C García Contreras, M J Rojas Giraldo, Y B Sánchez Fernández, M Alonso Ovies, N García Arpa, O González-Carpio Paredes, M J Grandes Muñoz, M Jara Peñacoba, A Lopez Villalvilla, M J Parellada Ruiz de la Cuesta, M Rodríguez Bastida, S Vicente Pérez, B Martín Porras, A González Valls, A Joglar Alcubilla, J Santa Cruz Hernández, C Castilla Álvarez, M García Viada, M A García-Abad Fernández, V Molina Bárcena, I Sepúlveda Gómez, P Cuadrado González, C Linares Sánchez, B Solans Aisa, T Francisco Romanillos, A García Ortego, P Hernández García-Alcalá, F Huguet Vivas, M L Juarez Zapatero, C López García, M J Manzano Martín, J A Martínez Torres, M Miguel Garzón, M P Rodrigo Rodrigo, M A Ruano Domínguez, D Aguilera Lafuente, N Altares Arriola, R Aranzo Pacheco, M Escudero Araus, C Fuentes Manrique, S Guijarro Abanades, A M López Carabaño, G D Moneva Vicente, M Pérez Fernández, T Rubio Rubio, M F Venegas Gato, M Blas Escribano, M M Castro Fouz, B Castro Sánchez, L Domínguez Pérez, P A García Gómez, A Herrero Dios, M Lor Leandro, I Lozano Marín, S Pacho Pinto, R Pastor Sánchez, M D Moreno Chaparro, E Yagüe Fernández, A Mateo Madruga, P Pumar Sainz, C Aragon Marente, M A Gomez Medina, J A Granados Garrido, I Gutierrez Sanchez, M J Heras Alonso, M R Herrero Pacheco, B Martín Peces, S Misericordia Garcia, S Ochoa Vilor, C Vargas Machuca, M A González Bellido, B Goncalves Molina, F Morata Cruz, L Moreno Carreras, M V Alda de la Fuente, L Hebeisen Andrés, O Fernández-Montes López-Morato, C Marcos de Frutos, V Ruiz Pascual, A Cayuela Maté, R M Fernández García, A Góngora Marín, S Perez Cuadrado, A Redondo Horcajo, I Á Rosario Pacheco, R M Villena Romero, O Hakami Hakami, M M Álvarez Villalba, M J Bedoya Frutos, A Hormigos Agraz, M T López López, B Perez Vallejo, M P Tardaguila Lobato, A Ballarín González, Y Fernández Fernández, I Ferrer Zapata, E Gómez Suárez, F Morales Ortiz, C Peláez Laguno, J L Quintana Gómez, E Rioja Delgado, J I Aza Pascual, D Fuente Arriarán, R A García Pérez, A Gárriz Aguirre, S Gómez Díaz, N Gonzalez Sanchez, C Sanz Velasco, J Vázquez Gallego, C Fernandez Durán, N Peña Antón, J M Blanco Canseco, E Minguela Puras, Eduardo Olano-Espinosa, Jose Francisco Avila-Tomas, Cesar Minue-Lorenzo, Blanca Matilla-Pardo, María Encarnación Serrano Serrano, F Javier Martinez-Suberviola, Mario Gil-Conesa, Isabel Del Cura-González, Dejal@ Group, L Molina Alameda, C Andrade Rosa, M Espejo Romero, J L Hernandez Garcia, E Perez Perez, J Zambrano Alvarez, F J Sanchez Jimenez, M Garcia Silva, I Martin Gomez, N Puyo Rodriguez, I Sanchez Vazquez, M T Garcia Alegre, C Moral Moraleda, O Perez Gandia, S Hernandez Rodriguez, J Aparicio Velasco, E Cerezo Pascual, C Marin Osorio, E Prieto Villegas, J Rodriguez Donoso, A Rodriguez Huete, F J Romero Blanco, S J Castillo Portales, R Collados Navas, P Gutierrez Sordo, M Sanchez Quejido, C Abad Schilling, M Capitan Jurado, M A Regalado del Valle, H C Alache Zuñiga, B Jaenes Barrios, M Ortiz Sánchez, M L Santiago Hernando, S Arjona Pérez, R Díaz Martin, B Fandiño García, M C Gómez Ortiz, M T López-Martin Aragón, M A Miguel Abanto, M Noguerol Álvarez, S Parra Roman, S Rey Rodríguez, E Aguilar Hurtado, M Aguilera Rubio, A I Carbonero Martín, M Esteban García, C Esteban De la Peña, C García Contreras, M J Rojas Giraldo, Y B Sánchez Fernández, M Alonso Ovies, N García Arpa, O González-Carpio Paredes, M J Grandes Muñoz, M Jara Peñacoba, A Lopez Villalvilla, M J Parellada Ruiz de la Cuesta, M Rodríguez Bastida, S Vicente Pérez, B Martín Porras, A González Valls, A Joglar Alcubilla, J Santa Cruz Hernández, C Castilla Álvarez, M García Viada, M A García-Abad Fernández, V Molina Bárcena, I Sepúlveda Gómez, P Cuadrado González, C Linares Sánchez, B Solans Aisa, T Francisco Romanillos, A García Ortego, P Hernández García-Alcalá, F Huguet Vivas, M L Juarez Zapatero, C López García, M J Manzano Martín, J A Martínez Torres, M Miguel Garzón, M P Rodrigo Rodrigo, M A Ruano Domínguez, D Aguilera Lafuente, N Altares Arriola, R Aranzo Pacheco, M Escudero Araus, C Fuentes Manrique, S Guijarro Abanades, A M López Carabaño, G D Moneva Vicente, M Pérez Fernández, T Rubio Rubio, M F Venegas Gato, M Blas Escribano, M M Castro Fouz, B Castro Sánchez, L Domínguez Pérez, P A García Gómez, A Herrero Dios, M Lor Leandro, I Lozano Marín, S Pacho Pinto, R Pastor Sánchez, M D Moreno Chaparro, E Yagüe Fernández, A Mateo Madruga, P Pumar Sainz, C Aragon Marente, M A Gomez Medina, J A Granados Garrido, I Gutierrez Sanchez, M J Heras Alonso, M R Herrero Pacheco, B Martín Peces, S Misericordia Garcia, S Ochoa Vilor, C Vargas Machuca, M A González Bellido, B Goncalves Molina, F Morata Cruz, L Moreno Carreras, M V Alda de la Fuente, L Hebeisen Andrés, O Fernández-Montes López-Morato, C Marcos de Frutos, V Ruiz Pascual, A Cayuela Maté, R M Fernández García, A Góngora Marín, S Perez Cuadrado, A Redondo Horcajo, I Á Rosario Pacheco, R M Villena Romero, O Hakami Hakami, M M Álvarez Villalba, M J Bedoya Frutos, A Hormigos Agraz, M T López López, B Perez Vallejo, M P Tardaguila Lobato, A Ballarín González, Y Fernández Fernández, I Ferrer Zapata, E Gómez Suárez, F Morales Ortiz, C Peláez Laguno, J L Quintana Gómez, E Rioja Delgado, J I Aza Pascual, D Fuente Arriarán, R A García Pérez, A Gárriz Aguirre, S Gómez Díaz, N Gonzalez Sanchez, C Sanz Velasco, J Vázquez Gallego, C Fernandez Durán, N Peña Antón, J M Blanco Canseco, E Minguela Puras

Abstract

Background: Tobacco addiction is the leading cause of preventable morbidity and mortality worldwide, but only 1 in 20 cessation attempts is supervised by a health professional. The potential advantages of mobile health (mHealth) can circumvent this problem and facilitate tobacco cessation interventions for public health systems. Given its easy scalability to large populations and great potential, chatbots are a potentially useful complement to usual treatment.

Objective: This study aims to assess the effectiveness of an evidence-based intervention to quit smoking via a chatbot in smartphones compared with usual clinical practice in primary care.

Methods: This is a pragmatic, multicenter, controlled, and randomized clinical trial involving 34 primary health care centers within the Madrid Health Service (Spain). Smokers over the age of 18 years who attended on-site consultation and accepted help to quit tobacco were recruited by their doctor or nurse and randomly allocated to receive usual care (control group [CG]) or an evidence-based chatbot intervention (intervention group [IG]). The interventions in both arms were based on the 5A's (ie, Ask, Advise, Assess, Assist, and Arrange) in the US Clinical Practice Guideline, which combines behavioral and pharmacological treatments and is structured in several follow-up appointments. The primary outcome was continuous abstinence from smoking that was biochemically validated after 6 months by the collaborators. The outcome analysis was blinded to allocation of patients, although participants were unblinded to group assignment. An intention-to-treat analysis, using the baseline-observation-carried-forward approach for missing data, and logistic regression models with robust estimators were employed for assessing the primary outcomes.

Results: The trial was conducted between October 1, 2018, and March 31, 2019. The sample included 513 patients (242 in the IG and 271 in the CG), with an average age of 49.8 (SD 10.82) years and gender ratio of 59.3% (304/513) women and 40.7% (209/513) men. Of them, 232 patients (45.2%) completed the follow-up, 104/242 (42.9%) in the IG and 128/271 (47.2%) in the CG. In the intention-to-treat analysis, the biochemically validated abstinence rate at 6 months was higher in the IG (63/242, 26%) compared with that in the CG (51/271, 18.8%; odds ratio 1.52, 95% CI 1.00-2.31; P=.05). After adjusting for basal CO-oximetry and bupropion intake, no substantial changes were observed (odds ratio 1.52, 95% CI 0.99-2.33; P=.05; pseudo-R2=0.045). In the IG, 61.2% (148/242) of users accessed the chatbot, average chatbot-patient interaction time was 121 (95% CI 121.1-140.0) minutes, and average number of contacts was 45.56 (SD 36.32).

Conclusions: A treatment including a chatbot for helping with tobacco cessation was more effective than usual clinical practice in primary care. However, this outcome was at the limit of statistical significance, and therefore these promising results must be interpreted with caution.

Trial registration: Clinicaltrials.gov NCT03445507; https://tinyurl.com/mrnfcmtd.

International registered report identifier (irrid): RR2-10.1186/s12911-019-0972-z.

Keywords: artificial intelligence; chatbot; dialog systems; mHealth; primary care; smartphone use; smoking; tobacco; tobacco cessation.

Conflict of interest statement

Conflicts of Interest: JFA-T, EO-E, and CM-L designed the chatbot and own the intellectual property rights. The remaining research team members (authors, developers, and sponsors) were not involved in the development of the intervention.

©Eduardo Olano-Espinosa, Jose Francisco Avila-Tomas, Cesar Minue-Lorenzo, Blanca Matilla-Pardo, María Encarnación Serrano Serrano, F Javier Martinez-Suberviola, Mario Gil-Conesa, Isabel Del Cura-González, Dejal@ Group. Originally published in JMIR mHealth and uHealth (https://mhealth.jmir.org), 27.06.2022.

Figures

Figure 1
Figure 1
Study Flowchart.

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