Trial for Tobacco Cessation With Intensive Advice in Diabetic Patients: the ITADI Project
ITADI
Community Intervention Trial for Smoking Cessation With Intensive Advice in Diabetic Patients in Primary Health Care
1 other identifier
interventional
722
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable diabetes-mellitus
Started Sep 2009
Typical duration for not_applicable diabetes-mellitus
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 6, 2009
CompletedFirst Posted
Study publicly available on registry
August 7, 2009
CompletedStudy Start
First participant enrolled
September 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2011
CompletedOctober 9, 2018
October 1, 2018
1.3 years
August 6, 2009
October 5, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
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
Study Arms (2)
Usual care
NO INTERVENTIONThe subjects in the control group will receive the usual care for smoking cessation in diabetic smokers.
Lifestyle Counseling
EXPERIMENTALThe 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
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.
Eligibility Criteria
You may qualify if:
- diabetic patients who are active smokers
- over the age of 14
- receive routine care in their respective health center
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
IDIAP Jordi Gol
Barcelona, 08007, Spain
Related Publications (1)
Roig L, Perez S, Prieto G, Martin C, Advani M, Armengol A, Roura P, Manresa JM, Briones E; ITADI Study Group. Cluster randomized trial in smoking cessation with intensive advice in diabetic patients in primary care. ITADI Study. BMC Public Health. 2010 Feb 4;10:58. doi: 10.1186/1471-2458-10-58.
PMID: 20132540DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Santiago Pérez, MD
CAP La Llagosta
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Doctor
Study Record Dates
First Submitted
August 6, 2009
First Posted
August 7, 2009
Study Start
September 1, 2009
Primary Completion
January 1, 2011
Study Completion
September 1, 2011
Last Updated
October 9, 2018
Record last verified: 2018-10