Trials · 2019
Smoking cessation opportunities in severe mental illness (tobacco intensive motivational and estimate risk - TIMER-): study protocol for a randomized controlled trial.
Протокол клинического исследованияСтатьяНазвание и аннотация: Перевод пока не подготовлен
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Jaén-Moreno María José, Feu Nuria, Redondo-Écija Justa, Montiel Francisco Javier, Gómez Cristina, Del Pozo Gloria I, Alcalá Jose Ángel, Gutiérrez-Rojas Luis, Balanzá-Martinez Vicente, Chauca Geli Marie, Carrión Laura, Osuna Maria Isabel, Sánchez María Dolores, Caro Inmaculada, Ayora Miriam, Valdivia Francisca, López María Soledad, Poyato Jose Manuel, Sarramea Fernando
Аннотация
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.
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.
Предметные рубрики MeSH
Bipolar DisorderHealth BehaviorHealth Knowledge, Attitudes, PracticeHumansLungMotivationMulticenter Studies as TopicPatient Education as TopicProspective StudiesPulmonary Disease, Chronic ObstructiveRandomized Controlled Trials as TopicSchizophreniaSchizophrenic PsychologySeverity of Illness IndexSmokingSmoking CessationSmoking PreventionSpainText MessagingTime FactorsTreatment Outcome