Trial for Tobacco Cessation With Intensive Advice in Diabetic Patients: the ITADI Project - Full Text View

Sponsors and Collaborators:	Jordi Gol i Gurina Foundation Unitat de Suport a la Recerca Metropolitana Nord. Unitat de Suport a la Recerca Barcelona. Consorci Sanitari de Terrassa
Information provided by:	Jordi Gol i Gurina Foundation
ClinicalTrials.gov Identifier:	NCT00954967

Purpose

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.

Condition	Intervention
Diabetes Mellitus Smoking Cessation	Behavioral: Lifestyle Counseling

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Community Intervention Trial for Smoking Cessation With Intensive Advice in Diabetic Patients in Primary Health Care

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Quitting Smoking Smoking Smoking and Youth

U.S. FDA Resources

Further study details as provided by Jordi Gol i Gurina Foundation:

Primary Outcome Measures:

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 [ Time Frame: 12 months after initiation of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Evolution of the phases of change of the Prochaska and DiClemente model [ Time Frame: 12 months after initiation of the study ] [ Designated as safety issue: No ]
Number of cigarettes per day [ Time Frame: 12 months after initiation of the study ] [ Designated as safety issue: No ]
Total time (minutes) spent in the intensive smoking cessation intervention [ Time Frame: 12 months after initiation of the study ] [ Designated as safety issue: No ]

Estimated Enrollment:	546
Study Start Date:	September 2009
Estimated Study Completion Date:	September 2011
Estimated Primary Completion Date:	January 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Usual care: No Intervention The subjects in the control group will receive the usual care for smoking cessation in diabetic smokers.
Lifestyle Counseling: Experimental 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.	Behavioral: 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.

Detailed Description:

Other objectives of the study are:

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.
To evaluate the effectiveness of an intensive smoking cessation intervention in the evolution of tabacco consumption in diabetic patients attended in primary care.
To quantify the time spent in the intensive smoking cessation intervention compared with the usual care in primary care.

Eligibility

Ages Eligible for Study:	14 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00954967

Contacts

Contact: Santiago Pérez, MD

+34 675 785 551

21923spt@comb.es

Locations

Spain
IDIAP Jordi Gol
Barcelona, Spain, 08007

Sponsors and Collaborators

Jordi Gol i Gurina Foundation

Unitat de Suport a la Recerca Metropolitana Nord.

Unitat de Suport a la Recerca Barcelona.

Consorci Sanitari de Terrassa

Investigators

Principal Investigator:

Santiago Pérez, MD

CAP La Llagosta

More Information

No publications provided

Responsible Party:	Institut Català de la Salut ( Santiago Pérez Tortosa )
Study ID Numbers:	PI08/90345
Study First Received:	August 6, 2009
Last Updated:	August 6, 2009
ClinicalTrials.gov Identifier:	NCT00954967 History of Changes
Health Authority:	Spain: Ministry of Health

Keywords provided by Jordi Gol i Gurina Foundation:

Diabetes Mellitus
Smoking Cessation
Primary Health Care
Motivational Interview

Study placed in the following topic categories:

Smoking
Metabolic Diseases
Diabetes Mellitus
Endocrine System Diseases

Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder

Additional relevant MeSH terms:

Habits
Smoking
Metabolic Diseases

Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on September 11, 2009