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
  Purpose

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.


Condition Intervention
Smoking Cessation
Behavioral: Advice
Behavioral: Motivational Interviewing
Drug: Nicotine Gum and Patch
Drug: Bupropion

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effectiveness of a Stepped Primary Care Smoking Cessation Intervention Based on an Evidence Based Clinical Practice Guideline (ISTAPS Project)

Resource links provided by NLM:


Further study details as provided by Jordi Gol i Gurina Foundation:

Primary Outcome Measures:
  • 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

Secondary Outcome Measures:
  • Health status measured by SF-36

Estimated Enrollment: 3012
Study Start Date: October 2003
Estimated Study Completion Date: July 2006
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   14 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00125905

Locations
Spain
Jordi Gol i Gurina Foundation-Primary Care Research Institute
Barcelona, Spain, 08007
Sponsors and Collaborators
Jordi Gol i Gurina Foundation
Preventive Services and Health Promotion Research Network
Investigators
Principal Investigator: Carmen Cabezas-Peña, MD Jordi Gol I Gurina Foundation-ICS
  More Information

Additional Information:
No publications provided by Jordi Gol i Gurina Foundation

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00125905     History of Changes
Other Study ID Numbers: PI021471, PI021471, G03/170
Study First Received: August 1, 2005
Last Updated: September 29, 2009
Health Authority: Spain: Ministry of Health

Keywords provided by Jordi Gol i Gurina Foundation:
Primary Care
Smoking Cessation
Stages of Change Model
Health Education
Clinical Practice guideline

Additional relevant MeSH terms:
Smoking
Habits
Nicotine
Bupropion
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Uptake Inhibitors

ClinicalTrials.gov processed this record on April 15, 2014