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

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

Status: Completed

Conditions: Diabetes Mellitus; Smoking Cessation

Treatments: Behavioral: Lifestyle Counseling

Study type: Interventional

Funder types: Other

Identifiers

NCT00954967

PI08/90345

Details and patient eligibility

About

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.

Full 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.

Enrollment: 722 patients

Sex: All

Ages: 14+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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722 participants in 2 patient groups

Usual care

No Intervention group

Description:

The subjects in the control group will receive the usual care for smoking cessation in diabetic smokers.

Lifestyle Counseling

Experimental group

Description:

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.

Treatment:

Behavioral: Lifestyle Counseling