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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2009 by Jordi Gol i Gurina Foundation.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborators:
Unitat de Suport a la Recerca Metropolitana Nord.
Unitat de Suport a la Recerca, Barcelona, Spain
Consorci Sanitari de Terrassa
Information provided by:
Jordi Gol i Gurina Foundation
ClinicalTrials.gov Identifier:
NCT00954967
First received: August 6, 2009
Last updated: NA
Last verified: August 2009
History: No changes posted
  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: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Community Intervention Trial for Smoking Cessation With Intensive Advice in Diabetic Patients in Primary Health Care

Resource links provided by NLM:

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
No Intervention: Usual care
The subjects in the control group will receive the usual care for smoking cessation in diabetic smokers.
Experimental: 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.
 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:

  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

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 Not yet recruiting
Barcelona, Spain, 08007
Contact: Mamta Advani, MPH     +34 615 941 347     estudi.itadi@gmail.com    
Contact: Elena Briones, Statistician     +34 93 567 56 40     estudi.itadi@gmail.com    
Sub-Investigator: Lydia Roig, MD            
Sub-Investigator: Gemma Prieto, MD            
Sub-Investigator: Carlos Martin, MD,PhD            
Sub-Investigator: Angelina Armengol, Nurse            
Sub-Investigator: Pilar Roura, MD, PhD            
Sub-Investigator: Ignasi Castells, MD            
Sub-Investigator: Imma Serra, Psychologist            
Sponsors and Collaborators
Jordi Gol i Gurina Foundation
Unitat de Suport a la Recerca Metropolitana Nord.
Unitat de Suport a la Recerca, Barcelona, Spain
Consorci Sanitari de Terrassa
Investigators
Principal Investigator: Santiago Pérez, MD CAP La Llagosta
  More Information

No publications provided by Jordi Gol i Gurina Foundation

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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

Keywords provided by Jordi Gol i Gurina Foundation:
Diabetes Mellitus
Smoking Cessation
Primary Health Care
Motivational Interview

Additional relevant MeSH terms:
Diabetes Mellitus
Smoking
Glucose Metabolism Disorders
 Metabolic Diseases
Endocrine System Diseases
Habits

ClinicalTrials.gov processed this record on May 22, 2013