Basic Area of Health La Llagosta, Catalan Institute of Health, (Carrer Vic, s/n), La Llagosta, (08120), Spain.
BMC Public Health. 2010 Feb 4;10:58. doi: 10.1186/1471-2458-10-58.
It is a priority to achieve smoking cessation in diabetic smokers, given that this is a group of patients with elevated cardiovascular risk. Furthermore, tobacco has a multiplying effect on micro and macro vascular complications. Smoking abstinence rates increase as the intensity of the intervention, length of the intervention and number and diversity of contacts with the healthcare professional during the intervention increases. However, there are few published studies about smoking cessation in diabetics in primary care, a level of healthcare that plays an essential role in these patients. Therefore, the aim of the present study is to evaluate the effectiveness of an intensive smoking cessation intervention in diabetic patients in primary care.
METHODS/DESIGN: Cluster randomized trial, controlled and multicentric. Randomization unit: Primary Care Team.
546 diabetic smokers older than 14 years of age whose disease is controlled by one of the primary care teams in the study.
Continuous tobacco abstinence (a person who has not smoked for at least six months and with a CO level of less than 6 ppm measured by a cooximeter) , evolution in the Prochaska and DiClemente's Transtheoretical Model of Change, number of cigarettes/day, length of the visit. Point of assessment: one- year post- inclusion in the study.
Brief motivational interview for diabetic smokers at the pre-contemplation and contemplation stage, intensive motivational interview with pharmacotherapy for diabetic smokers in the preparation-action stage and reinforcing intevention in the maintenance stage.
A descriptive analysis of all variables will be done, as well as a multilevel logistic regression and a Poisson regression. All analyses will be done with an intention to treatment basis and will be fitted for potential confounding factors and variables of clinical importance. Statistical packages: SPSS15, STATA10 y HLM6.
The present study will try to describe the profile of a diabetic smoker who receives the most benefit from an intensive intervention in primary care. The results will be useful for primary care professionals in their usual clinical practice.
Clinical Trials.gov Identifier: NCT00954967.
鉴于糖尿病吸烟者心血管风险较高，该人群应优先戒烟。此外，烟草会使微血管和大血管并发症恶化。随着干预的强度、干预的持续时间以及干预期间与医护人员的接触次数和种类的增加，戒烟率会提高。然而，在初级保健中，很少有关于糖尿病患者戒烟的研究，而初级保健在这些患者中起着至关重要的作用。因此，本研究旨在评估强化戒烟干预在初级保健中糖尿病患者中的有效性。
方法/设计：整群随机对照试验，设对照和多中心。随机单位：基层医疗团队。
年龄大于 14 岁且疾病通过研究中一个基层医疗团队控制的糖尿病吸烟者。
持续烟草戒断（指至少 6 个月未吸烟且一氧化碳仪检测的 CO 水平低于 6ppm 的个体）、Prochaska 和 DiClemente 改变阶段理论模型中的变化、每日吸烟量、就诊时间。评估点：研究纳入后 1 年。
对处于未考虑和考虑阶段的糖尿病吸烟者进行简短动机性访谈，对处于准备-行动阶段的糖尿病吸烟者进行强化动机性访谈和药物治疗，并在维持阶段进行强化干预。
将对所有变量进行描述性分析，还将进行多水平逻辑回归和泊松回归。所有分析均基于意向治疗原则，并针对潜在混杂因素和临床重要变量进行拟合。统计软件：SPSS15、STATA10 和 HLM6。
本研究将尝试描述从初级保健强化干预中获益最大的糖尿病吸烟者的特征。研究结果将对初级保健专业人员的日常临床实践有用。
ClinicalTrials.gov 标识符：NCT00954967。
