Laura Carrasco?Hernández|Francisco Jódar?Sánchez|Francisco J. Núñez-Benjumea|Jesús Moreno-Conde|Marco Mesa González|A Balcells|Santiago Hors-Fraile|Carlos Calderón|Panagiotis D. Bamidis|Francisco Órtega Ruiz
A Mobile Health Solution Complementing Psychopharmacology-Supported Smoking Cessation: Randomized Controlled Trial
Centro de Investigación Biomédica en Red de Enfermedades Respiratorias|Hospital Universitario Virgen del Rocío|Instituto de Biomedicina de Sevilla|Hospital Universitario Virgen del Rocío|Universidad de Sevilla|Instituto de Biomedicina de Sevilla|Hospital Universitario Virgen del Rocío|Universidad de Sevilla|Instituto de Biomedicina de Sevilla|Hospital Universitario Virgen del Rocío|Universidad de Sevilla|Hospital Universitario Virgen del Rocío|Universidad de Sevilla|Instituto de Biomedicina de Sevilla|Hospital Universitario Virgen del Rocío|Universidad de Sevilla|Aristotle University of Thessaloniki|Hospital Universitario Virgen del Rocío
background smoking cessation persistent leading public health challenge mobile health mhealth solutions emerging improve smoking cessation treatments previous approaches proposed supporting cessation tailored motivational messages managed provide shortterm improvements smoking cessation yet approaches either static terms personalization humanbased nonscalable solutions additionally longterm effects neither presented assessed combination existing psychopharmacological therapies objective study aimed analyze longterm efficacy mobile app supporting psychopharmacological therapy smoking cessation complementarily assess involved innovative technology methods 12month randomized openlabel parallelgroup trial comparing smoking cessation rates performed virgen del roco university hospital seville spain smokers randomly allocated control group cg receiving usual care psychopharmacological treatment n120 intervention group ig receiving psychopharmacological treatment using mobile app providing artificial intelligencegenerated tailored smoking cessation support messages n120 secondary objectives analyze healthrelated quality life monitor healthy lifestyle physical exercise habits safety assessed according presence adverse events related pharmacological therapy perprotocol intentiontotreat analyses performed incomplete data multinomial regression analyses performed assess variables influencing participant cessation probability technical solution assessed according precision tailored motivational smoking cessation messages user engagement cessation cessation subgroups compared using tests voluntary satisfaction questionnaire administered end intervention participants completed trial results ig abstinence 275 times higher adjusted 345 p01 perprotocol analysis 215 times higher adjusted 313 p002 intentiontotreat analysis lost data analysis multinomial logistic models showed different patterns participants dropped regarding safety 14 120 117 ig participants 13 120 108 cg participants 19 23 adverse events respectively p84 none clinical secondary objective measures showed relevant differences groups system able learn tailor messages improved effectiveness supporting smoking cessation unable reduce time message sent opened either case relevant difference cessation cessation subgroups however significant difference found system engagement 6 months p04 subsequent months high system appreciation reported end study conclusions proposed mhealth solution complementing psychopharmacological therapy showed greater efficacy achieving 1year tobacco abstinence compared psychopharmacological therapy alone provides basis artificial intelligencebased future approaches trial registration clinicaltrialsgov nct03553173 httpsclinicaltrialsgovct2shownct03553173 international registered report identifier irrid rr210219612464