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Clinical Trials/NCT00954967
NCT00954967
Completed
Not Applicable

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

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina1 site in 1 country722 target enrollmentSeptember 2009

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Diabetes Mellitus
Sponsor
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Enrollment
722
Locations
1
Primary Endpoint
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
Status
Completed
Last Updated
7 years ago

Overview

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: 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.

Registry
clinicaltrials.gov
Start Date
September 2009
End Date
September 2011
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Responsible Party
Principal Investigator
Principal Investigator

USR Metropolitana Nord

Doctor

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

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

Outcomes

Primary Outcomes

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

  • 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 Sites (1)

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