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Completed

NCT Number: NCT00954967

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

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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Key information

Conditions

Diabetes Mellitus Behavior Endocrine System Diseases Glucose Metabolism Disorders Health Behavior Metabolic Diseases Nutritional and Metabolic Diseases Smoking Cessation

Age range

14 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IDIAP Jordi Gol

Barcelona, 08007, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lifestyle Counseling

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.

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

    Time frame: 12 months after initiation of study

Secondary outcomes

  1. Evolution of the phases of change of the Prochaska and DiClemente model

    Time frame: 12 months after initiation of the study

  2. Number of cigarettes per day

    Time frame: 12 months after initiation of the study

  3. Total time (minutes) spent in the intensive smoking cessation intervention

    Time frame: 12 months after initiation of the study

Sponsors and collaborators

Lead sponsor

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

Other

Collaborators

  • Consorci Sanitari de Terrassa
  • Institut Catala de Salut

Registry information

Official study title

Community Intervention Trial for Smoking Cessation With Intensive Advice in Diabetic Patients in Primary Health Care

Acronym: ITADI

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Aug 7, 2009
Registry last updated
Oct 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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