Cluster randomized trial in smoking cessation with intensive advice in diabetic patients in primary care. ITADI Study

BMC Public Health

Study Protocol

Pilar Roura¹  Angelina Armengol²  Lydia Roig³  Santiago Perez⁴  Carlos Martin⁵  Gemma Prieto⁶  Mamta Advani⁷  Elena Briones⁸  Josep Maria Manresa⁹ 

[1] ABS Badia, Catalan Institute of Health (Carrer Bètica), Badia del Vallés, (08214), Spain;ABS Terrassa Nord, Catalan Institute of Health, (Carrer Mercè Rodoreda 24), (08207), Terrassa, Spain;Basic Area of Health La Garriga, Catalan Institute of Health, (Passeig de l'Ametlla,17), (08480), La Garriga, Spain;Basic Area of Health La Llagosta, Catalan Institute of Health, (Carrer Vic, s/n), (08120), La Llagosta, Spain;Basic Area of Health Passeig Sant Joan, Catalan Institute of Health, (Passeig Sant Joan 29), (08010), Barcelona, Spain;Gerencia de Atención Primaria de Ávila, Sanidad de Castilla y Léon, (Avenida Portugal 47), (05001), Àvila, Spain;Scientific Area, IDIAP Jordi Gol, (Gran Via de les Corts Catalanes 587), (08007), Barcelona, Spain;USR Barcelona, IDIAP Jordi Gol, (St Elies 42), (08006), Barcelona, Spain;USR Metropolitana Nord, IDIAP Jordi Gol, (08203), Sabadell, Spain;

关键词: Smoking Cessation;    Varenicline;    Tobacco Consumption;    Motivational Interview;    Smoking Abstinence;   

DOI  :  10.1186/1471-2458-10-58

 received in 2009-12-22, accepted in 2010-02-04,  发布年份 2010

来源: Springer

【 摘 要 】

BackgroundIt 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/DesignCluster randomized trial, controlled and multicentric. Randomization unit: Primary Care Team. Study population: 546 diabetic smokers older than 14 years of age whose disease is controlled by one of the primary care teams in the study. Outcome Measures: 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. Intervention: 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. Statistical Analysis: 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.DiscussionThe 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.Trial RegistrationClinical Trials.gov Identifier: NCT00954967

【 授权许可】

Unknown   
© Roig et al; licensee BioMed Central Ltd. 2010. This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.