Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

ISTAPS: A Stepped Primary Care Smoking Cessation Intervention

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2003 by Jordi Gol i Gurina Foundation.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Preventive Services and Health Promotion Research Network
Information provided by:
Jordi Gol i Gurina Foundation
ClinicalTrials.gov Identifier:
NCT00125905
First received: August 1, 2005
Last updated: September 29, 2009
Last verified: November 2003

August 1, 2005
September 29, 2009
October 2003
Not Provided
  • 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
Same as current
Complete list of historical versions of study NCT00125905 on ClinicalTrials.gov Archive Site
Health status measured by SF-36
Health status measured by SF-36.
Not Provided
Not Provided
 
ISTAPS: A Stepped Primary Care Smoking Cessation Intervention
Effectiveness of a Stepped Primary Care Smoking Cessation Intervention Based on an Evidence Based Clinical Practice Guideline (ISTAPS Project)

Primary care centers can play a very important role in helping people to stop smoking. There is a large body of research on the effectiveness of specific interventions especially addressed to people who want to stop smoking. In addition to that, there are no studies with a large sample of individuals included that tested the complete range of interventions recommended nowadays for helping people in the different smoking cessation stages of change and with different degrees of physical and psychological dependence, especially including motivational interviewing in those not interested in cessation in the very next weeks. This study will test a complex intervention that at first classifies smokers in stages and after that treats every smoker according to what stage he/she is in at the moment, his/her degree of dependence and his/her own characteristics.

OBJECTIVES:

  • 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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Smoking Cessation
  • Behavioral: Advice
  • Behavioral: Motivational Interviewing
  • Drug: Nicotine Gum and Patch
  • Drug: Bupropion
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
3012
July 2006
Not Provided

Inclusion Criteria:

  • Smokers
  • Accept participation and follow-up by phone interviews for 2 years

Exclusion Criteria:

  • Terminal illness
  • Active addictive behaviours or important health problems
Both
14 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT00125905
PI021471, PI021471, G03/170
Not Provided
Not Provided
Jordi Gol i Gurina Foundation
Preventive Services and Health Promotion Research Network
Principal Investigator: Carmen Cabezas-Peña, MD Jordi Gol I Gurina Foundation-ICS
Jordi Gol i Gurina Foundation
November 2003

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP