Clinical trial NCT00954967: Trial for Tobacco Cessation With Intensive Advice in Diabetic Patients: the ITADI Project
Official title: Community Intervention Trial for Smoking Cessation With Intensive Advice in Diabetic Patients in Primary Health Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Smoking Cessation
Keywords: Diabetes Mellitus
Smoking Cessation
Primary Health Care
Motivational Interview
Lead sponsor: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Sponsor class: OTHER
Collaborators: name: Institut Catala de Salut
name: Consorci Sanitari de Terrassa
First posted: 2009-08-07
Enrollment: 722
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study addresses an important problem in public health, smoking in diabetics. The morbidity and mortality observed in diabetics is linked to macro and microvascular problems. The consumption of tobacco has a multiplying effect on these vascular problems in diabetics. This study aims to evaluate the effectiveness of an intensive intervention in tobacco addiction in diabetic patients in primary care.

Detailed description: Other objectives of the study are:

1. To study the effectiveness of an intensive smoking cessation intervention in the evolution of the phases of change, as based on the Prochaska and DiClemente model, in diabetic patients attended in primary care.
2. To evaluate the effectiveness of an intensive smoking cessation intervention in the evolution of tabacco consumption in diabetic patients attended in primary care.
3. To quantify the time spent in the intensive smoking cessation intervention compared with the usual care in primary care.

Eligibility criteria: Inclusion Criteria:

* diabetic patients who are active smokers
* over the age of 14
* receive routine care in their respective health center

Exclusion Criteria:

* patients with communication difficulties (cognitive deterioration, language barrier)
* patients who normally receive their habitual care in a different health center
* patients with terminal diseases, psychiatric diseases that are unstable, or with addictions to other substances
* patients that are already receiving treatment to quit smoking at the time of recruitment
* patients that are difficult to locate during the study period
* patients that refuse to participate in the study

Primary outcomes:
measure: Smoking abstinence: Self reported abstinence (6 or more months without smoking) confirmed by an expired air carbon monoxide concentration of 6 parts per millions or less
timeFrame: 12 months after initiation of study
Secondary outcomes:
measure: Evolution of the phases of change of the Prochaska and DiClemente model
timeFrame: 12 months after initiation of the study
measure: Number of cigarettes per day
timeFrame: 12 months after initiation of the study
measure: Total time (minutes) spent in the intensive smoking cessation intervention
timeFrame: 12 months after initiation of the study
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: IDIAP Jordi Gol
Study officials:
affiliation: CAP La Llagosta
name: Santiago Pérez, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Roig L, Perez S, Prieto G, Martin C, Advani M, Armengol A, Roura P, Manresa JM, Briones E; ITADI Study Group. Cluster randomized trial in smoking cessation with intensive advice in diabetic patients in primary care. ITADI Study. BMC Public Health. 2010 Feb 4;10:58. doi: 10.1186/1471-2458-10-58.