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

Lydia Roig,Itadi Study Group ,Gemma Prieto,Santiago Perez,Mamta Advani,Elena Briones,Josep Maria Manresa,Angelina Armengol,Carlos Martin,Pilar Roura

doi:10.1186/1471-2458-10-58

Abstract

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

Highlights

It is a priority to achieve smoking cessation in diabetic smokers, given that this is a group of patients with elevated cardiovascular risk
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

Summary

Introduction

It is a priority to achieve smoking cessation in diabetic smokers, given that this is a group of patients with elevated cardiovascular risk. 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. The aim of the present study is to evaluate the effectiveness of an intensive smoking cessation intervention in diabetic patients in primary care. It is known that tobacco is the principal isolated cause of avoidable morbimortality in developed countries. The morbimortality observed in diabetics is related to macro and microvascular complications, and tobacco has a multiplying effect on these vascular complications. A number of studies have found evidence relating tobacco consumption to the development of nephropathies in type 1 and 2 diabetes mellitus [4]. It has been shown that the tobacco consumption is a risk factor for the development and progression of diabetic neuropathies [5]

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