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ISTAPS: A Stepped Primary Care Smoking Cessation Intervention

NCT ID: NCT00125905

Last Updated: 2009-09-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

3012 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-10-31

Study Completion Date

2006-07-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Smoking Cessation

Keywords

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Primary Care Smoking Cessation Stages of Change Model Health Education Clinical Practice guideline

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Advice

Intervention Type BEHAVIORAL

Motivational Interviewing

Intervention Type BEHAVIORAL

Nicotine Gum and Patch

Intervention Type DRUG

Bupropion

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

14 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Preventive Services and Health Promotion Research Network

OTHER

Sponsor Role collaborator

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

OTHER

Sponsor Role lead

Principal Investigators

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Carmen Cabezas-Peña, MD

Role: PRINCIPAL_INVESTIGATOR

Jordi Gol I Gurina Foundation-ICS

Locations

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Jordi Gol i Gurina Foundation-Primary Care Research Institute

Barcelona, Barcelona, Spain

Site Status

Countries

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Spain

References

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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.

Reference Type DERIVED
PMID: 21605389 (View on PubMed)

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.

Reference Type DERIVED
PMID: 21561497 (View on PubMed)

Other Identifiers

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PI021471

Identifier Type: -

Identifier Source: secondary_id

G03/170

Identifier Type: -

Identifier Source: secondary_id

PI021471

Identifier Type: -

Identifier Source: org_study_id