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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)

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00125905
Enrollment
3012
Registered
2005-08-02
Start date
2003-10-31
Completion date
2006-07-31
Last updated
2009-09-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Smoking Cessation

Keywords

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

Brief summary

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

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.

Interventions

BEHAVIORALAdvice
BEHAVIORALMotivational Interviewing
DRUGNicotine Gum and Patch
DRUGBupropion

Sponsors

Preventive Services and Health Promotion Research Network
CollaboratorOTHER
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
14 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Health status measured by SF-36

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 29, 2026