Cluster randomized trial in smoking cessation with intensive advice in diabetic patients in primary care. ITADI Study.
BACKGROUND
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
Cluster randomized trial, controlled and multicentric. Randomization unit: Primary Care Team.


METHODS
546 diabetic smokers older than 14 years of age whose disease is controlled by one of the primary care teams in the study.


METHODS
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.


METHODS
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.


METHODS
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.


CONCLUSIONS
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.


BACKGROUND
Clinical Trials.gov Identifier: NCT00954967.
Basic Area of Health La Llagosta, Catalan Institute of Health, (Carrer Vic, s/n), La Llagosta, (08120), Spain.
Lydia
L
Roig
Santiago
S
Perez
Gemma
G
Prieto
Carlos
C
Martin
Mamta
M
Advani
Angelina
A
Armengol
Pilar
P
Roura
Josep Maria
JM
Manresa
Elena
E
Briones
D001294:Attitude to Health; D003625:Data Collection; D003920:Diabetes Mellitus; D005260:Female; D006801:Humans; D007407:Interviews as Topic; D008297:Male; D009042:Motivation; D010348:Patient Care Team; D018579:Patient Selection; D011320:Primary Health Care; D012107:Research Design; D012907:Smoking / Q000628:therapy; D016540:Smoking Cessation