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

Primary Purpose

Diabetes Mellitus, Smoking Cessation

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Lifestyle Counseling
Sponsored by
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus focused on measuring Diabetes Mellitus, Smoking Cessation, Primary Health Care, Motivational Interview

Eligibility Criteria

14 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • IDIAP Jordi Gol

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Usual care

Lifestyle Counseling

Arm Description

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

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.

Outcomes

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

Secondary Outcome Measures

Evolution of the phases of change of the Prochaska and DiClemente model
Number of cigarettes per day
Total time (minutes) spent in the intensive smoking cessation intervention

Full Information

First Posted
August 6, 2009
Last Updated
October 5, 2018
Sponsor
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Collaborators
Institut Catala de Salut, Consorci Sanitari de Terrassa
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1. Study Identification

Unique Protocol Identification Number
NCT00954967
Brief Title
Trial for Tobacco Cessation With Intensive Advice in Diabetic Patients: the ITADI Project
Acronym
ITADI
Official Title
Community Intervention Trial for Smoking Cessation With Intensive Advice in Diabetic Patients in Primary Health Care
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
September 2009 (Actual)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Collaborators
Institut Catala de Salut, Consorci Sanitari de Terrassa

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Smoking Cessation
Keywords
Diabetes Mellitus, Smoking Cessation, Primary Health Care, Motivational Interview

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
722 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual care
Arm Type
No Intervention
Arm Description
The subjects in the control group will receive the usual care for smoking cessation in diabetic smokers.
Arm Title
Lifestyle Counseling
Arm Type
Experimental
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Lifestyle Counseling
Intervention 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.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Evolution of the phases of change of the Prochaska and DiClemente model
Time Frame
12 months after initiation of the study
Title
Number of cigarettes per day
Time Frame
12 months after initiation of the study
Title
Total time (minutes) spent in the intensive smoking cessation intervention
Time Frame
12 months after initiation of the study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Santiago Pérez, MD
Organizational Affiliation
CAP La Llagosta
Official's Role
Principal Investigator
Facility Information:
Facility Name
IDIAP Jordi Gol
City
Barcelona
ZIP/Postal Code
08007
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
20132540
Citation
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.
Results Reference
derived

Learn more about this trial

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

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