Trial for Tobacco Cessation With Intensive Advice in Diabetic Patients: the ITADI Project

Not Applicable

Completed

• Conditions: Smoking Cessation; Diabetes Mellitus
• Interventions: Behavioral: Lifestyle Counseling

• Registration Number: NCT00954967
• Lead Sponsor: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

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.

Study Timeline

• Study First Submitted: 2009-08-06
• Study First Submitted QC: 2009-08-06
• Study First Posted: 2009-08-07
• Study Start: 2009-09
• Primary Completion: 2011-01
• Study Completion: 2011-09
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-05
• Last Update Posted: 2018-10-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 722

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lifestyle Counseling	Lifestyle Counseling	The intervention is based on lifestyle advice, motivational interviewing and the use of medications, using the Clinical Practice Guidelines of the Catalan Institute of Health. Health professionals in the intervention group receive a training on the abovementioned techniques.

Primary Outcome Measures

Name	Time	Method
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	12 months after initiation of study

Secondary Outcome Measures

Name	Time	Method
Evolution of the phases of change of the Prochaska and DiClemente model	12 months after initiation of the study
Number of cigarettes per day	12 months after initiation of the study
Total time (minutes) spent in the intensive smoking cessation intervention	12 months after initiation of the study

Trial Locations

Locations (1)

IDIAP Jordi Gol; 🇪🇸 Barcelona, Spain