ISTAPS: A Stepped Primary Care Smoking Cessation Intervention
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|ClinicalTrials.gov Identifier: NCT00125905|
Recruitment Status : Unknown
Verified November 2003 by Jordi Gol i Gurina Foundation.
Recruitment status was: Active, not recruiting
First Posted : August 2, 2005
Last Update Posted : September 30, 2009
|Condition or disease||Intervention/treatment||Phase|
|Smoking Cessation||Behavioral: Advice Behavioral: Motivational Interviewing Drug: Nicotine Gum and Patch Drug: Bupropion||Not Applicable|
- To evaluate the effectiveness of a stepped smoking cessation intervention based on a transtheoretical model of change that uses the pharmacological and no-pharmacological methods proposed by evidence based Clinical Practice Guidelines for smoking cessation from primary care centers.
- To assess the health status change in relationship with the smoking cessation process.
DESIGN: Cluster randomized clinical trial
Unit of Randomization: Care basic unit (family physician or nurse that cares for the same group of patients). Intention to treat analysis.
PARTICIPANTS: 2911 smokers (ages 14-75 years) consulting for any reason to primary care centers
INTERVENTION: 6-month implementation of recommendations of a Clinical Practice Guideline that includes motivational consulting for smokers at the precontemplation - contemplation stage; brief intervention for smokers in preparation-action who do not want help; intensive intervention with pharmacotherapies for smokers in preparation-action who want help; and reinforcing intervention in the maintenance stage.
CONTROL: Usual care
MEASUREMENT: Self reported abstinence confirmed by an expired air carbon monoxide concentration of 10 parts per millions or less; Point prevalence at the end of intervention, 1 and 2 years after the beginning of intervention; Continuous abstinence rate for 1 year; Change of stage in the smoking cessation process; Health status measured by SF-36.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||3012 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effectiveness of a Stepped Primary Care Smoking Cessation Intervention Based on an Evidence Based Clinical Practice Guideline (ISTAPS Project)|
|Study Start Date :||October 2003|
|Study Completion Date :||July 2006|
- Self reported abstinence confirmed by an expired air carbon monoxide concentration of 10 parts per millions or less
- Point prevalence at the end of intervention, 1 and 2 years after the beginning of intervention
- Continuous abstinence rate for 1 year
- Change of stage in the smoking cessation process
- Health status measured by SF-36
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00125905
|Jordi Gol i Gurina Foundation-Primary Care Research Institute|
|Barcelona, Spain, 08007|
|Principal Investigator:||Carmen Cabezas-Peña, MD||Jordi Gol I Gurina Foundation-ICS|