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
BackgroundIntensive interventions on smoking cessation increase abstinence rates. However, few electronic mail (E-mail) based intensive interventions have been tested in smokers and none in primary care (PC) setting. The aim of the present study is to evaluate the effectiveness of an intensive E-mail based intervention in smokers attending PC services.Methods/designRandomized Controlled Multicentric Trial. Study population: 1060 smokers aged between 18–70 years from Catalonia, Salamanca and Aragón (Spain) who have and check regularly an E-mail account. Patients will be randomly assigned to control or intervention group. Intervention: Six phase intensive intervention with two face to face interviews and four automatically created and personal E-mail patients tracking, if needed other E-mail contacts will be made. Control group will receive a brief advice on smoking cessation. Outcome measures: Will be measured at 6 and 12 months after intervention: self reported continuous abstinence (confirmed by cooximetry), point prevalence abstinence, tobacco consumption, evolution of stage according to Prochaska and DiClemente's Stages of Change Model, length of visit, costs for the patient to access Primary Care Center. Statistical analysis: Descriptive and logistic and Poisson regression analysis under the intention to treat basis using SPSS v.17.DiscussionThe proposed intervention is an E-mail based intensive intervention in smokers attending primary care. Positive results could be useful to demonstrate a higher percentage of short and long-term abstinence among smokers attended in PC in Spain who regularly use E-mail. Furthermore, this intervention could be helpful in all health services to help smokers to quit.Trial RegistrationClinical Trials.gov Identifier: NCT01494246.
BackgroundLiterature shows that not only are traffic injuries due to accidents, but that there is also a correlation between different chronic conditions, the consumption of certain types of drugs, the intake of psychoactive substances and the self perception of risk (Health Belief Model) and the impact/incidence of traffic accidents. There are few studies on these aspects in primary health care.The objectives of our study are:Main aim: To outline the distribution of risk factors associated with Road Traffic Injuries (RTI) in a driving population assigned to a group of primary health care centres in Barcelona province.Secondly, we aim to study the distribution of diverse risk factors related to the possibility of suffering an RTI according to age, sex and population groups, to assess the relationship between these same risk factors and self risk perception for suffering an RTI, and to outline the association between the number of risk factors and the history of reported collisions.Methods/DesignDesign: Cross-sectional, multicentre study.Setting: 25 urban health care centres.Study population: Randomly selected sample of Spanish/Catalan speakers age 16 or above with a medical register in any of the 25 participating primary health care centres. N = 1540.Unit of study: Basic unit of care, consisting of a general practitioner and a nurse, both of whom caring for the same population (1,500 to 2,000 people per unit).Instruments of measurement: Data collection will be performed using a survey carried out by health professionals, who will use the clinical registers and the information reported by the patient during the visit to collect the baseline data: illnesses, medication intake, alcohol and psychoactive consumption, and self perception of risk.DiscussionWe expect to obtain a risk profile of the subjects in relation to RTI in the primary health care field, and to create a group for a prospective follow-up.Trial RegistrationClinical Trials.gov Identifier: NCT00778440.
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