- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00125905
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)
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Barcelona, Spain, 08007
- Jordi Gol i Gurina Foundation-Primary Care Research Institute
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Self reported abstinence confirmed by an expired air carbon monoxide concentration of 10 parts per millions or less
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Point prevalence at the end of intervention, 1 and 2 years after the beginning of intervention
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Continuous abstinence rate for 1 year
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Change of stage in the smoking cessation process
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Secondary Outcome Measures
Outcome Measure |
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Health status measured by SF-36
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Carmen Cabezas-Peña, MD, Jordi Gol I Gurina Foundation-ICS
Publications and helpful links
General Publications
- Puente D, Cabezas C, Rodriguez-Blanco T, Fernandez-Alonso C, Cebrian T, Torrecilla M, Clemente L, Martin C; ISTAPS study group investigators. The role of gender in a smoking cessation intervention: a cluster randomized clinical trial. BMC Public Health. 2011 May 23;11:369. doi: 10.1186/1471-2458-11-369.
- Cabezas C, Advani M, Puente D, Rodriguez-Blanco T, Martin C; ISTAPS Study Group. Effectiveness of a stepped primary care smoking cessation intervention: cluster randomized clinical trial (ISTAPS study). Addiction. 2011 Sep;106(9):1696-706. doi: 10.1111/j.1360-0443.2011.03491.x. Epub 2011 Jul 22.
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Cholinergic Agents
- Enzyme Inhibitors
- Psychotropic Drugs
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Antidepressive Agents
- Dopamine Agents
- Cytochrome P-450 Enzyme Inhibitors
- Ganglionic Stimulants
- Nicotinic Agonists
- Cholinergic Agonists
- Antidepressive Agents, Second-Generation
- Cytochrome P-450 CYP2D6 Inhibitors
- Dopamine Uptake Inhibitors
- Nicotine
- Bupropion
Other Study ID Numbers
- PI021471
- G03/170
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