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This trial was funded by the Fondo de Investigaciones Sanitarias (FIS) del Instituto de Salud Carlos III (ISCIII), the European Regional Development Fund (ERDF) under registration number PI17/01942. The funders had no role in the study design or in the decision to submit the report for publication. Also, they will not take part in the collection or analysis of data, nor in the assessment of the outcomes. The funding body has already performed a peer-review of the trial protocol.; The main researcher received a grant from the Fundacion para la Investigacion e Innovacion Biomedica en Atencion Primaria (FIIBAP) 2018 Call for grants for promoting research programs.

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

Publicated to:Bmc Medical Informatics And Decision Making. 19 (1): 249- - 2019-12-03 19(1), DOI: 10.1186/s12911-019-0972-z

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

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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.

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