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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

722 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2011-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Diabetes Mellitus Smoking Cessation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Usual care

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

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

Lifestyle Counseling

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No