Smoking cessation opportunities in severe mental illness (tobacco intensive motivational and estimate risk — TIMER—): study protocol for a randomized controlled trial

Abstract Background There is an increased risk of premature death in people with severe mental illness (SMI). Respiratory disorders and cardiovascular disease are leading causes of increased mortality rates in these patients, and tobacco consumption remains the most preventable risk factor involved....

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Main Authors: María José Jaén-Moreno, Nuria Feu, Justa Redondo-Écija, Francisco Javier Montiel, Cristina Gómez, Gloria I. del Pozo, Jose Ángel Alcalá, Luis Gutiérrez-Rojas, Vicente Balanzá-Martinez, Geli Marie Chauca, Laura Carrión, Maria Isabel Osuna, María Dolores Sánchez, Inmaculada Caro, Miriam Ayora, Francisca Valdivia, María Soledad López, Jose Manuel Poyato, Fernando Sarramea
Format: Article
Language:English
Published: BMC 2019-01-01
Series:Trials
Subjects:
Online Access:http://link.springer.com/article/10.1186/s13063-018-3139-9
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author María José Jaén-Moreno
Nuria Feu
Justa Redondo-Écija
Francisco Javier Montiel
Cristina Gómez
Gloria I. del Pozo
Jose Ángel Alcalá
Luis Gutiérrez-Rojas
Vicente Balanzá-Martinez
Geli Marie Chauca
Laura Carrión
Maria Isabel Osuna
María Dolores Sánchez
Inmaculada Caro
Miriam Ayora
Francisca Valdivia
María Soledad López
Jose Manuel Poyato
Fernando Sarramea
author_facet María José Jaén-Moreno
Nuria Feu
Justa Redondo-Écija
Francisco Javier Montiel
Cristina Gómez
Gloria I. del Pozo
Jose Ángel Alcalá
Luis Gutiérrez-Rojas
Vicente Balanzá-Martinez
Geli Marie Chauca
Laura Carrión
Maria Isabel Osuna
María Dolores Sánchez
Inmaculada Caro
Miriam Ayora
Francisca Valdivia
María Soledad López
Jose Manuel Poyato
Fernando Sarramea
author_sort María José Jaén-Moreno
collection DOAJ
description Abstract Background There is an increased risk of premature death in people with severe mental illness (SMI). Respiratory disorders and cardiovascular disease are leading causes of increased mortality rates in these patients, and tobacco consumption remains the most preventable risk factor involved. Developing new tools to motivate patients towards cessation of smoking is a high priority. Information on the motivational value of giving the lung age and prevention opportunities is unknown in this high-risk population. Methods/design This article describes in detail a protocol developed to evaluate an intensive motivational tool, based on the individual risks of pulmonary damage and prevention opportunities. It is designed as a randomized, 12-month, follow-up, multicenter study. A minimum of 204 smokers will be included, aged 40 years and older, all of whom are patients diagnosed with either schizophrenia or bipolar disorder (BD). Chronic obstructive pulmonary disease (COPD) will be evaluated using spirometry, and the diagnosis will then be validated by a pneumologist and the lung age estimated. Based on this value, a motivational message about prevention will be issued for the intervention group, which will be reinforced by individualized text messages over a period of 3 months. The efficacy of the method and the pulmonary damage variables will be evaluated: smoking cessation at the end of follow-up will be confirmed by cooximetry, and the COPD diagnosis and the severity of the staging for disease will be assessed. Discussion In the context of community care, screening and early detection of lung damage could potentially be used, together with mobile technology, in order to produce a prevention message, which may provide patients with SMI with a better chance of quitting smoking. Trial registration ClinicalTrials.gov, ID: NCT03583203. Registered on 11 July 2018. Trial status: recruitment.
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spelling doaj.art-7c6ce8f78b414a8ab97808dc3793e8af2022-12-21T18:52:13ZengBMCTrials1745-62152019-01-0120111110.1186/s13063-018-3139-9Smoking cessation opportunities in severe mental illness (tobacco intensive motivational and estimate risk — TIMER—): study protocol for a randomized controlled trialMaría José Jaén-Moreno0Nuria Feu1Justa Redondo-Écija2Francisco Javier Montiel3Cristina Gómez4Gloria I. del Pozo5Jose Ángel Alcalá6Luis Gutiérrez-Rojas7Vicente Balanzá-Martinez8Geli Marie Chauca9Laura Carrión10Maria Isabel Osuna11María Dolores Sánchez12Inmaculada Caro13Miriam Ayora14Francisca Valdivia15María Soledad López16Jose Manuel Poyato17Fernando Sarramea18Instituto Maimónides de Investigación Biomédica de Córdoba (IMIBIC)Unidad de Gestión Clínica de Neumología, Hospital Universitario Reina SofíaUnidad de Drogas y Adicciones, Instituto Provincial de Bienestar Social, Diputación de CórdobaUnidad de Gestión Clínica de Salud Mental, Complejo Hospitalario de JaénUnidad de Gestión Clínica de Salud Mental, Complejo Hospitalario de JaénUnidad de Gestión Clínica de Salud Mental, Hospital Universitario Reina SofíaUnidad de Gestión Clínica de Salud Mental, Hospital Universitario Reina SofíaGrupo de Investigación Psiquiatría y Neurociencias (CTS-549), Instituto de Neurociencias, Universidad de GranadaÁrea de Psiquiatría y Psicología Médica. Departamento de Medicina, Servicio de Psiquiatría, Universidad de Valencia, CIBERSAM, Hospital Universitario y Politécnico La FeUnidad de Gestión Clínica de Salud Mental, Hospital Infanta MargaritaUnidad de Gestión Clínica de Salud Mental, Hospital Infanta MargaritaUnidad de Gestión Clínica de Salud Mental, Hospital Universitario Virgen de la VictoriaUnidad de Gestión Clínica de Salud Mental, Complejo Hospitalario de JaénUnidad de Gestión Clínica de Salud Mental, Hospital Universitario Virgen de la VictoriaUnidad de Psiquiatría del niño y del adolescente, Hospital Universitario Gregorio MarañónUnidad de Gestión Clínica de Salud Mental, Hospital Universitario Reina SofíaUnidad de Gestión Clínica de Salud Mental, Hospital Infanta MargaritaUnidad de Gestión Clínica de Salud Mental, Hospital Universitario Reina SofíaInstituto Maimónides de Investigación Biomédica de Córdoba (IMIBIC)Abstract Background There is an increased risk of premature death in people with severe mental illness (SMI). Respiratory disorders and cardiovascular disease are leading causes of increased mortality rates in these patients, and tobacco consumption remains the most preventable risk factor involved. Developing new tools to motivate patients towards cessation of smoking is a high priority. Information on the motivational value of giving the lung age and prevention opportunities is unknown in this high-risk population. Methods/design This article describes in detail a protocol developed to evaluate an intensive motivational tool, based on the individual risks of pulmonary damage and prevention opportunities. It is designed as a randomized, 12-month, follow-up, multicenter study. A minimum of 204 smokers will be included, aged 40 years and older, all of whom are patients diagnosed with either schizophrenia or bipolar disorder (BD). Chronic obstructive pulmonary disease (COPD) will be evaluated using spirometry, and the diagnosis will then be validated by a pneumologist and the lung age estimated. Based on this value, a motivational message about prevention will be issued for the intervention group, which will be reinforced by individualized text messages over a period of 3 months. The efficacy of the method and the pulmonary damage variables will be evaluated: smoking cessation at the end of follow-up will be confirmed by cooximetry, and the COPD diagnosis and the severity of the staging for disease will be assessed. Discussion In the context of community care, screening and early detection of lung damage could potentially be used, together with mobile technology, in order to produce a prevention message, which may provide patients with SMI with a better chance of quitting smoking. Trial registration ClinicalTrials.gov, ID: NCT03583203. Registered on 11 July 2018. Trial status: recruitment.http://link.springer.com/article/10.1186/s13063-018-3139-9SchizophreniaBipolar disorderTobacco cessationChronic obstructive pulmonary diseaseScreeningMobile technology
spellingShingle María José Jaén-Moreno
Nuria Feu
Justa Redondo-Écija
Francisco Javier Montiel
Cristina Gómez
Gloria I. del Pozo
Jose Ángel Alcalá
Luis Gutiérrez-Rojas
Vicente Balanzá-Martinez
Geli Marie Chauca
Laura Carrión
Maria Isabel Osuna
María Dolores Sánchez
Inmaculada Caro
Miriam Ayora
Francisca Valdivia
María Soledad López
Jose Manuel Poyato
Fernando Sarramea
Smoking cessation opportunities in severe mental illness (tobacco intensive motivational and estimate risk — TIMER—): study protocol for a randomized controlled trial
Trials
Schizophrenia
Bipolar disorder
Tobacco cessation
Chronic obstructive pulmonary disease
Screening
Mobile technology
title Smoking cessation opportunities in severe mental illness (tobacco intensive motivational and estimate risk — TIMER—): study protocol for a randomized controlled trial
title_full Smoking cessation opportunities in severe mental illness (tobacco intensive motivational and estimate risk — TIMER—): study protocol for a randomized controlled trial
title_fullStr Smoking cessation opportunities in severe mental illness (tobacco intensive motivational and estimate risk — TIMER—): study protocol for a randomized controlled trial
title_full_unstemmed Smoking cessation opportunities in severe mental illness (tobacco intensive motivational and estimate risk — TIMER—): study protocol for a randomized controlled trial
title_short Smoking cessation opportunities in severe mental illness (tobacco intensive motivational and estimate risk — TIMER—): study protocol for a randomized controlled trial
title_sort smoking cessation opportunities in severe mental illness tobacco intensive motivational and estimate risk timer study protocol for a randomized controlled trial
topic Schizophrenia
Bipolar disorder
Tobacco cessation
Chronic obstructive pulmonary disease
Screening
Mobile technology
url http://link.springer.com/article/10.1186/s13063-018-3139-9
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