NCT00125905

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
3,012

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2003

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2003

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

August 1, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 2, 2005

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2006

Completed
Last Updated

September 30, 2009

Status Verified

November 1, 2003

First QC Date

August 1, 2005

Last Update Submit

September 29, 2009

Conditions

Keywords

Primary CareSmoking CessationStages of Change ModelHealth EducationClinical Practice guideline

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (1)

  • Health status measured by SF-36

Interventions

Eligibility Criteria

Age14 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Terminal illness
  • Active addictive behaviours or important health problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jordi Gol i Gurina Foundation-Primary Care Research Institute

Barcelona, Barcelona, 08007, Spain

Location

Related Publications (2)

  • 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.

MeSH Terms

Conditions

Smoking CessationHealth Education

Interventions

CounselingMotivational InterviewingNicotine Chewing GumTransdermal PatchBupropion

Condition Hierarchy (Ancestors)

Health BehaviorBehaviorAdherence InterventionsMedication AdherencePatient CompliancePatient Acceptance of Health CareTreatment Adherence and Compliance

Intervention Hierarchy (Ancestors)

Mental Health ServicesBehavioral Disciplines and ActivitiesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesDirective CounselingChewing GumPlant GumsBiopolymersPolymersMacromolecular SubstancesPolysaccharidesCarbohydratesTobacco Use Cessation DevicesTherapeuticsCandyFoodDiet, Food, and NutritionPhysiological PhenomenaFood and BeveragesEquipment and SuppliesPropiophenonesKetonesOrganic Chemicals

Study Officials

  • Carmen Cabezas-Peña, MD

    Jordi Gol I Gurina Foundation-ICS

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 1, 2005

First Posted

August 2, 2005

Study Start

October 1, 2003

Study Completion

July 1, 2006

Last Updated

September 30, 2009

Record last verified: 2003-11

Locations