Effectiveness of a chat-bot for the adult population to quit smoking: protocol of a pragmatic clinical trial in primary care (Dejal@)

J F Avila-Tomas, E Olano-Espinosa, C Minué-Lorenzo, F J Martinez-Suberbiola, B Matilla-Pardo, M E Serrano-Serrano, E Escortell-Mayor, Group Dej@lo, A M Garcia-Mesa, C Gomez, E Liebana-Nistal, L Molina-Alameda, C Andrade-Rosa, A Caballero-Jiménez, G Escribano-Romo, M Espejo-Romero, A Ferrero-Brenes, J L Hernandez-Garcia, E Perez-Perez, J Zambrano-Alvarez, E Ayuso-Hernandez, M J Cuesta-Monedero, F J Sanchez-Jimenez, A Vigil-Escalera, S Casado-Nistal, M Garcia-Alva, I Martin-Gomez, N Puyo-Rodriguez, A Rodriguez-Cosio, I Sanchez-Vazquez, M A Alcala-Olmo, M T Garcia-Alegre, M Garcia-Alva, C Hurtado-Monterrubio, T Martin-Burillo, C Moral-Moraleda, E Ciria Holgado, C Hermoso-Duran, S Hernandez-Rodriguez, A L Lafraya-Puente, J L Melero-Serrano, M J Molina-Sanchez, E Muñiz-Dominguez, C Saiz-Loma-Osorio, J Aparicio-Velasco, E Cerezo-Pascual, L Fonte-Elizondo, M I Gomez-Martinez, C Marin-Osorio, P Orozco-Diaz, E Prieto-Villegas, J Rodriguez-Donoso, A Rodriguez-Huete, F J Romero-Blanco, J P Urbano-Fernandez, S J Castillo-Portales, R Collados-Navas, P Gutierrez-Sordo, M B Martin-Sacristan-Martin, M Sanchez-Quejido, C Abad-Schilling, S Arenas-Gonzalez, M E Calonge-Garcia, M Capitan-Jurado, S Menendez-Alvarez, M A Regalado-Valle, H C Alache-Zuñiga, E Cerrada-Cerrada, R Garcia-Camps, M J Gutierrez-Notario, J Mendez-Cabezas-Velazquez, J Molina-Paris, H Pensado-Freire, G Viñas-Fernandez, B Jaenes-Barrios, M Jurado-Sueiro, M Ortiz-Sanchez, M L Santiago-Hernando, S Arjona-Perez, I Delgado-Mellado, R Diaz-Martin, B Fandiño-Garcia, M C Gomez-Ortiz, M T Lopez-Martin-Aragon, C Martinez-Alvaro, M A Miguel-Abanto, M Noguerol-Alvarez, S Parra-Roman, Z Pascual-Garcia, A L Ranz-Granados, S Rey-Rodriguez, C Sanz-Perez, E Aguilar-Hurtado, M Aguilera-Rubio, A I Carbonero-Martin, M Esteban-Garcia, C Esteban-Peña, M Fernandez-Sanchez, C Garcia-Contreras, A M Hernandez-Sanchez, M L Herrera-Garcia, A Herrero-Fuentes, M Oria-Rodriguez, M S Parra-Martin, M J Rojas-Giraldo, A Saiz-Ordoño, Y B Sanchez-Fernandez, P Villasevil-Robledo, M Alonso-Ovies, A Diaz-Martin, N Garcia-Arpa, F Garcia-Rodriguez, O Gonzalez-Carpio-Paredes, M J Grandes-Muñoz, M Jara-Peñacoba, A Lopez-Villalbilla, M J Parellada-Ruiz-Cuesta, A I Rabadan-Velasco, M Rodriguez-Bastida, C Sobrado-Cemeño, A Valdez-Jaquez, S Vicente-Perez, B Matin-Porras, A Gonzalez-Valls, V Joglar-Alcubilla, J Santa-Cruz-Hernandez, M E Serrano-Serrano, C Castilla-Alvarez, M A Garcia-Abad-Fernandez, M Garcia-Viada, S Hernandez-Lachehab, L Lopez-Kollmer, A Miguel-Ballano, V Molina-Barcena, R Ortega-Pineda, I Sepulveda-Gomez, P Cuadrado-Gonzalez, M J Jimenez-Moreno, C Linares-Sanchez, M A Pardo-Garcia, F Sanchez-Martin, R Simon-Gutierrez, B Solans-Aisa, T Francisco-Romanillos, A Garcia-Ortega, P Hernandez-Garcia-Alcala, F Huguet-Vivas, M L Juarez-Zapatero, C Lopez-Garcia, M J Manzano-Martin, J A Martinez-Torres, M Miguel-Garzon, M P Rodrigo-Rodrigo, M A Ruano-Dominguez, A Serna-Urnicia, N Altares-Arriola, R Aranzo-Pacheco, C Casado-Rodriguez, C Cascao-Moutinho-Pereira, M Escudero-Araus, C Fuentes-Manrique, S Guijarro-Abanades, P Hombrados-Gonzalo, A M Lopez-Carabaño, M L Meiriño-Perez, G D Moneva-Vicente, I Noguera-Martinez, M Perez-Fernandez, M Robres-Olite, T Rubio-Rubio, M F Venegas-Gato, F Bernal-Hertfelder, M Blas-Escribano, M M Castro-Fouz, B Castro-Sanchez, L Dominguez-Perez, P A Garcia-Gomez, A Herrero-Dios, M Lor-Leandro, I Lozano-Martin, S Pacho-Pinto, R Pastor-Sanchez, M D Moreno-Chaparro, E Yagüe-Fernandez, M J Lopez, A Mateo-Madruga, J L Palancar-Torre, P Pumar-Sainz, C Aragon-Marente, M A Gomez-Medina, J A Granados-Garrido, I Gutierrez-Sanchez, M J Heras-Alonso, M J Lopez-Gomez, B Martin-Peces, F J Martinez-Suberbiola, A Medran-Gomez, G Nuevo-Rodriguez, S Ochoa-Vilor, C Vargas-Machuca, O Fernandez-Montes-Lopez-Morato, R Jimenez-Rojas, C Marcos-Frutos, C Minguet-Arenas, C Minue-Lorenzo, V Ruiz-Pascual, I Sanchez-Fonseca, J M Sanchez-Gonzalez, F Alba-Gomez, J F Avila-Tomas, A Cayuela-Mate, E Cidoncha-Calderon, A B Cifuentes-Muñoz, R M Fernandez-Garcia, J L Gala-Paniagua, A Gongora-Marin, P Herrero-Municio, E Moreno-Chocano-Garcia-Carpintero, S Perez-Cuadrado, A Redondo-Horcajo, C Vicente-Sanchez, R M Villena-Romero, O Hakami-Hakami, M M Alvarez-Villalba, M J Bedoya-Frutos, J Camarero-Palacios, M Escobar-Gallegos, A Hormigos-Agraz, J Innerarity-Martínez, M T Lopez-Lopez, B Perez-Ballesto, E Perez-Gutierrez, M P Tardaguila-Lobato, R Terron-Barbosa, A Ballarin-Gonzalez, Y Fernandez-Fernandez, I Ferrer-Zapata, E Gomez-Suarez, M Lamonaca-Guasch, F Morales-Ortiz, C Pelaez-Laguno, J L Quintana-Gomez, E Rioja-Delgado, J I Aza-Pascual, D Fuente-Arriaran, R A Garcia-Perez, A Garriz-Aguirre, S Gomez-Diaz, P Gonzalez-Palacios, N Gonzalez-Sanchez, G Peralta-Alvarez, C Sanz-Velasco, J Vazquez-Gallego, C Vazquez-Garcia, C Fernandez-Duran, N Peña-Anton, J M Blanco-Canseco, I Gamez-Cabero, E Minguela-Puras, J Serrano-Vega, J F Avila-Tomas, E Olano-Espinosa, C Minué-Lorenzo, F J Martinez-Suberbiola, B Matilla-Pardo, M E Serrano-Serrano, E Escortell-Mayor, Group Dej@lo, A M Garcia-Mesa, C Gomez, E Liebana-Nistal, L Molina-Alameda, C Andrade-Rosa, A Caballero-Jiménez, G Escribano-Romo, M Espejo-Romero, A Ferrero-Brenes, J L Hernandez-Garcia, E Perez-Perez, J Zambrano-Alvarez, E Ayuso-Hernandez, M J Cuesta-Monedero, F J Sanchez-Jimenez, A Vigil-Escalera, S Casado-Nistal, M Garcia-Alva, I Martin-Gomez, N Puyo-Rodriguez, A Rodriguez-Cosio, I Sanchez-Vazquez, M A Alcala-Olmo, M T Garcia-Alegre, M Garcia-Alva, C Hurtado-Monterrubio, T Martin-Burillo, C Moral-Moraleda, E Ciria Holgado, C Hermoso-Duran, S Hernandez-Rodriguez, A L Lafraya-Puente, J L Melero-Serrano, M J Molina-Sanchez, E Muñiz-Dominguez, C Saiz-Loma-Osorio, J Aparicio-Velasco, E Cerezo-Pascual, L Fonte-Elizondo, M I Gomez-Martinez, C Marin-Osorio, P Orozco-Diaz, E Prieto-Villegas, J Rodriguez-Donoso, A Rodriguez-Huete, F J Romero-Blanco, J P Urbano-Fernandez, S J Castillo-Portales, R Collados-Navas, P Gutierrez-Sordo, M B Martin-Sacristan-Martin, M Sanchez-Quejido, C Abad-Schilling, S Arenas-Gonzalez, M E Calonge-Garcia, M Capitan-Jurado, S Menendez-Alvarez, M A Regalado-Valle, H C Alache-Zuñiga, E Cerrada-Cerrada, R Garcia-Camps, M J Gutierrez-Notario, J Mendez-Cabezas-Velazquez, J Molina-Paris, H Pensado-Freire, G Viñas-Fernandez, B Jaenes-Barrios, M Jurado-Sueiro, M Ortiz-Sanchez, M L Santiago-Hernando, S Arjona-Perez, I Delgado-Mellado, R Diaz-Martin, B Fandiño-Garcia, M C Gomez-Ortiz, M T Lopez-Martin-Aragon, C Martinez-Alvaro, M A Miguel-Abanto, M Noguerol-Alvarez, S Parra-Roman, Z Pascual-Garcia, A L Ranz-Granados, S Rey-Rodriguez, C Sanz-Perez, E Aguilar-Hurtado, M Aguilera-Rubio, A I Carbonero-Martin, M Esteban-Garcia, C Esteban-Peña, M Fernandez-Sanchez, C Garcia-Contreras, A M Hernandez-Sanchez, M L Herrera-Garcia, A Herrero-Fuentes, M Oria-Rodriguez, M S Parra-Martin, M J Rojas-Giraldo, A Saiz-Ordoño, Y B Sanchez-Fernandez, P Villasevil-Robledo, M Alonso-Ovies, A Diaz-Martin, N Garcia-Arpa, F Garcia-Rodriguez, O Gonzalez-Carpio-Paredes, M J Grandes-Muñoz, M Jara-Peñacoba, A Lopez-Villalbilla, M J Parellada-Ruiz-Cuesta, A I Rabadan-Velasco, M Rodriguez-Bastida, C Sobrado-Cemeño, A Valdez-Jaquez, S Vicente-Perez, B Matin-Porras, A Gonzalez-Valls, V Joglar-Alcubilla, J Santa-Cruz-Hernandez, M E Serrano-Serrano, C Castilla-Alvarez, M A Garcia-Abad-Fernandez, M Garcia-Viada, S Hernandez-Lachehab, L Lopez-Kollmer, A Miguel-Ballano, V Molina-Barcena, R Ortega-Pineda, I Sepulveda-Gomez, P Cuadrado-Gonzalez, M J Jimenez-Moreno, C Linares-Sanchez, M A Pardo-Garcia, F Sanchez-Martin, R Simon-Gutierrez, B Solans-Aisa, T Francisco-Romanillos, A Garcia-Ortega, P Hernandez-Garcia-Alcala, F Huguet-Vivas, M L Juarez-Zapatero, C Lopez-Garcia, M J Manzano-Martin, J A Martinez-Torres, M Miguel-Garzon, M P Rodrigo-Rodrigo, M A Ruano-Dominguez, A Serna-Urnicia, N Altares-Arriola, R Aranzo-Pacheco, C Casado-Rodriguez, C Cascao-Moutinho-Pereira, M Escudero-Araus, C Fuentes-Manrique, S Guijarro-Abanades, P Hombrados-Gonzalo, A M Lopez-Carabaño, M L Meiriño-Perez, G D Moneva-Vicente, I Noguera-Martinez, M Perez-Fernandez, M Robres-Olite, T Rubio-Rubio, M F Venegas-Gato, F Bernal-Hertfelder, M Blas-Escribano, M M Castro-Fouz, B Castro-Sanchez, L Dominguez-Perez, P A Garcia-Gomez, A Herrero-Dios, M Lor-Leandro, I Lozano-Martin, S Pacho-Pinto, R Pastor-Sanchez, M D Moreno-Chaparro, E Yagüe-Fernandez, M J Lopez, A Mateo-Madruga, J L Palancar-Torre, P Pumar-Sainz, C Aragon-Marente, M A Gomez-Medina, J A Granados-Garrido, I Gutierrez-Sanchez, M J Heras-Alonso, M J Lopez-Gomez, B Martin-Peces, F J Martinez-Suberbiola, A Medran-Gomez, G Nuevo-Rodriguez, S Ochoa-Vilor, C Vargas-Machuca, O Fernandez-Montes-Lopez-Morato, R Jimenez-Rojas, C Marcos-Frutos, C Minguet-Arenas, C Minue-Lorenzo, V Ruiz-Pascual, I Sanchez-Fonseca, J M Sanchez-Gonzalez, F Alba-Gomez, J F Avila-Tomas, A Cayuela-Mate, E Cidoncha-Calderon, A B Cifuentes-Muñoz, R M Fernandez-Garcia, J L Gala-Paniagua, A Gongora-Marin, P Herrero-Municio, E Moreno-Chocano-Garcia-Carpintero, S Perez-Cuadrado, A Redondo-Horcajo, C Vicente-Sanchez, R M Villena-Romero, O Hakami-Hakami, M M Alvarez-Villalba, M J Bedoya-Frutos, J Camarero-Palacios, M Escobar-Gallegos, A Hormigos-Agraz, J Innerarity-Martínez, M T Lopez-Lopez, B Perez-Ballesto, E Perez-Gutierrez, M P Tardaguila-Lobato, R Terron-Barbosa, A Ballarin-Gonzalez, Y Fernandez-Fernandez, I Ferrer-Zapata, E Gomez-Suarez, M Lamonaca-Guasch, F Morales-Ortiz, C Pelaez-Laguno, J L Quintana-Gomez, E Rioja-Delgado, J I Aza-Pascual, D Fuente-Arriaran, R A Garcia-Perez, A Garriz-Aguirre, S Gomez-Diaz, P Gonzalez-Palacios, N Gonzalez-Sanchez, G Peralta-Alvarez, C Sanz-Velasco, J Vazquez-Gallego, C Vazquez-Garcia, C Fernandez-Duran, N Peña-Anton, J M Blanco-Canseco, I Gamez-Cabero, E Minguela-Puras, J Serrano-Vega

Abstract

Background: 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. Thus, the purpose of this study is to assess the effectiveness of an intervention that helps people cease smoking and increase their nicotine abstinence rates in the long term via a chat-bot, compared to usual practice, utilizing a chemical validation at 6 months.

Methods: Design: Randomized, controlled, multicentric, pragmatic clinical trial, with a 6-month follow-up.

Setting: Healthcare centers in the public healthcare system of the Community of Madrid (Madrid Regional Health Service).

Participants: Smokers > 18 years of age who attend a healthcare center and accept help to quit smoking in the following month. N = 460 smokers (230 per arm) who will be recruited prior to randomization. Intervention group: use of a chat-bot with evidence-based contents to help quit smoking.

Control group: Usual treatment (according to the protocol for tobacco cessation by the Madrid Regional Health Service Main variable: Continuous nicotine withdrawal with chemical validation (carbon monoxide in exhaled air). Intention-to-treat analysis. Difference between groups in continuous abstinence rates at 6 months with their corresponding 95% confidence interval. A logistic regression model will be built to adjust for confounding factors.

Results: First expected results in January 2020.

Discussion: Providing science-based evidence on the effectiveness of clinical interventions via information technologies, without the physical presence of a professional, is essential. In addition to being more efficient, the characteristics of these interventions can improve effectiveness, accessibility, and adherence to treatment. From an ethics perspective, this new type of intervention must be backed by scientific evidence to circumvent pressures from the market or particular interests, improve patient safety, and follow the standards of correct practices for clinical interventions.

Trial registration: ClinicalTrials.gov, reference number NCT03445507.

Keywords: Cell phone use; Chat-bot; Dialog systems; Primary care; Smoking; Tobacco cessation.

Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Protocol
Fig. 2
Fig. 2
Pat plot intervention Dej@lo

References

    1. Mathers C, World Health Organization . WHO global report mortality attributable to tobacco [internet] Geneva: World Health Organization; 2012.
    1. Aveyard P, West R. Managing smoking cessation. BMJ. 2007;335:37–41. doi: 10.1136/bmj.39252.591806.47.
    1. National Institute for Health and Clinical Excellence . Smoking cessation services in primary care, pharmacies, local authorities and workplaces, particularly for manual working groups, pregnant women and hard to reach communities. NICE public health guidance 10. London: NICE; 2008.
    1. Treating tobacco use and dependence: 2008 update - NCBI Bookshelf [Internet]. [cited 2012 Sep 28].
    1. Minué-Lorenzo C, Olano-Espinosa E, del Cura-González I, Vizcaíno-Sánchez J, Camarelles-Guillem F, Granados-Garrido J, et al. Subsidized pharmacological treatment for smoking cessation by the Spanish public health system: a randomized, pragmatic,clinical trial by clusters. Tob Induc Dis. 2019;17:64. doi: 10.18332/tid/111368.
    1. Thorndike AN, Regan S, Rigotti NA. The treatment of smoking by US physicians during ambulatory visits: 1994–2003. Am J Public Health. 2007;97:1878–1883. doi: 10.2105/AJPH.2006.092577.
    1. Brotons C, Bjorkelund C. BulcM, et al. Prevention and health promotion in clinical practice: the views of general practitioners in Europe. Prev Med. 2005;40(5):595–601. doi: 10.1016/j.ypmed.2004.07.020.
    1. Saito A. Health proffessionals perceptions of and potential barriers to smoking cessation care. BMC Res Notes. 2010;3:329. doi: 10.1186/1756-0500-3-329.
    1. Pisinger C, Vestbo J, Borch-Johnsen K, Thomsen T, Jørgensen T. Acceptance of the smoking cessation intervention in a large population-based study: the Inter99 study. Scand J Public Health. 2005;33(2):138–145. doi: 10.1080/14034940410028370.
    1. Aveyard P, Begh R, Parsons A, West R. Brief opportunistic smoking cessation interventions: a systematic review and meta-analysis to compare advice to quit and offer of assistance: Brief interventions for smoking cessation. Addiction. 2012;107(6):1066–1073. doi: 10.1111/j.1360-0443.2011.03770.x.
    1. The State of Broadband:Broadband catalyzing sustainable development. International Telecommunications Union. Septiembre 2018.
    1. Milani R, Franklin C. The Role of Technology in Healthy Living Medicine. Prog Cardiovasc Dis. 2017;59:487–491. doi: 10.1016/j.pcad.2017.02.001.
    1. Free C, Phillips G, Galli L, Watson L, Felix L, Edwards P, et al. The effectiveness of mobile-health technology-based health behaviour change or disease management interventions for health care consumers: a systematic review. PLoS Med. 2013;10(1):e1001362. doi: 10.1371/journal.pmed.1001362.
    1. Whittaker R, McRobbie H, Bullen C, Rodgers A, Gu Y. Mobile phone-based interventions for smoking cessation. Cochrane Database Syst Rev. 2016;4:CD006611.
    1. Abroms LC, Westmaas JL, Bontemps-Jones J, Ramani R, Mellerson J. A content analysis of popular smartphone apps for smoking cessation. Am J Prev Med. 2013;45:732–736. doi: 10.1016/j.amepre.2013.07.008.
    1. Haskins B, Lesperance D, Gibbons P, Boudreaux E. A systematic review of smartphone applications for smoking cessation. Transl Behav Med. 2017;7:292–299. doi: 10.1007/s13142-017-0492-2.
    1. Aplicación de algoritmos genéticos y sistemas expertos en medicina asistencial. Aplicaciones clínicas de la inteligencia artificial. Informes de evaluación de Tecnologías sanitarias. AETSA 2009 / 6. ISBN: 978–84–96990-87-6. Ed. Ministerio de Ciencia e Innovación, 2011. Available only in Spanish.
    1. Crutzen RY, Peters GJ, Portugal SD, Fisser EM, Grolleman J. An artificially intelligent chat agent that answers adolescents’ questions related to sex, drugs, and alcohol: an exploratory study. J Adolesc Health. 2011;48:514–519. doi: 10.1016/j.jadohealth.2010.09.002.
    1. Grolleman J, Van Dijk B, Nijholt A, et al. Break the habit! Designing an e-therapy intervention using a virtual coach in aid of smoking cessation. Lect Notes Comput Sci. 2006;3962:133–141. doi: 10.1007/11755494_19.
    1. West Rm Hayek P, Stead L, Stapleton J. Outcome criteria in smoking cessation trials: proposal for a common standard. Addiction. 2005;100(3):299–303. doi: 10.1111/j.1360-0443.2004.00995.x.
    1. Van Hout B, Janssen MF, Feng YS, et al. Interim scoring for the EQ-5D-5L: mapping the EQ-5D-5L to EQ-5D-3L value sets. Value Health. 2012;15(5):708–715. doi: 10.1016/j.jval.2012.02.008.
    1. Otero Lopez MJ, Codina JC, Tames Alonso MJ, et al. Medication errors: standarizing the terminology and taxomany. Ruiz Jarabo 2000 grand results. Farm Hosp. 2003;27(3):137–149.
    1. Moher D, Hopewell S, Schulz KF, Montori V, Gøtzsche PC, Devereaux PJ, Elbourne D, Egger M, Altman DG. CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. BMJ. 2010;340:c869. doi: 10.1136/bmj.c869.
    1. Barnes SA, Larsen MD, Schroeder D, Hanson A, Decker PA. Missing data assumptions and methods in a smoking cessation study. Addiction. 2010;105(3):431–437. doi: 10.1111/j.1360-0443.2009.02809.x.
    1. Thorpe KE, Zwarenstein M, Oxman AD, Treweek S, Furberg CD, Altman DG, et al. A pragmatic-explanatory continuum indicator summary (PRECIS): a tool to help trial designers. J Clin Epidemiol. 2009;62:464–475. doi: 10.1016/j.jclinepi.2008.12.011.

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