严重精神疾病患者的戒烟机会（烟草强化动机与风险评估——TIMER）：一项随机对照试验的研究方案

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

作者信息

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

机构信息

Instituto Maimónides de Investigación Biomédica de Córdoba (IMIBIC), Córdoba, Spain.

Departamento de Ciencias Sociosanitarias, Radiología y Medicina Física, Universidad de Córdoba, Córdoba, Spain.

出版信息

Trials. 2019 Jan 14;20(1):47. doi: 10.1186/s13063-018-3139-9.

DOI:10.1186/s13063-018-3139-9

PMID:30642365

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6332915/

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.

摘要

背景

重症精神疾病（SMI）患者过早死亡的风险增加。呼吸系统疾病和心血管疾病是这些患者死亡率上升的主要原因，而烟草消费仍然是最可预防的风险因素。开发新工具以促使患者戒烟是当务之急。在这一高危人群中，关于提供肺龄和预防机会的激励价值的信息尚不清楚。

方法/设计：本文详细描述了一项为评估基于肺部损伤个体风险和预防机会的强化激励工具而制定的方案。它被设计为一项随机、为期12个月的随访多中心研究。将纳入至少204名年龄在40岁及以上的吸烟者，他们均为被诊断患有精神分裂症或双相情感障碍（BD）的患者。将使用肺活量测定法评估慢性阻塞性肺疾病（COPD），然后由肺科医生对诊断进行验证并估算肺龄。基于这一数值，将为干预组发布一条关于预防的激励信息，并在3个月的时间内通过个性化短信加以强化。将评估该方法的疗效和肺部损伤变量：随访结束时的戒烟情况将通过一氧化碳测定法确认，COPD诊断和疾病分期的严重程度将得到评估。