ISTAPS: A Stepped Primary Care Smoking Cessation Intervention
|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|
|Smoking Cessation||Behavioral: Advice Behavioral: Motivational Interviewing Drug: Nicotine Gum and Patch Drug: Bupropion|
- 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)|
|Estimated 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|
|Estimated 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
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|