NCT01194596

Brief Summary

The purpose of this study is to evaluate the effectiveness of the spirometric results information advice about the smoking habit the investigators designed an intervention trial in primary care. Hypothesis: In adult smokers, smoking cessation advice combined with a discussion of the spirometric tests on the part of the practitioner achieves a higher rate of tobacco reduction and abandonment than just smoking cessation advice. Expected results: In adult smokers, a detailed discussion of the results yielded by spirometry tests together with brief smoking cessation advice on the part of the primary care practitioner can facilitate tobacco reduction and abandonment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
596

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2008

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

June 1, 2008

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 2, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 3, 2010

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

February 27, 2023

Status Verified

February 1, 2023

Enrollment Period

2 years

First QC Date

September 2, 2010

Last Update Submit

February 24, 2023

Conditions

Keywords

smoking cessation advicespirometryprimary health care

Outcome Measures

Primary Outcomes (1)

  • smoking abstinence: self reported abstinence (12 or more months)

    smoking abstinence confirmed by an expired air carbon monoxide

    12 months

Secondary Outcomes (1)

  • smoking reduction: self reported reduction

    12 months

Study Arms (2)

Spirometry and lifestyle counseling

EXPERIMENTAL

Intervention group: will be given a brief but structured smoking cessation advice (according to the standards of the Tobacco Study Group of the Catalan Society of Family Medicine) together with a detailed and structured discussion of the spirometric results.

Behavioral: Smoking cessation adviceBehavioral: Spirometry and smoking cessation advice

Lifestyle counseling

NO INTERVENTION

No intervention group: will be given a brief but structured smoking cessation advice (according to the standards of the Tobacco Study Group of the Catalan Society of Family Medicine).

Interventions

Brief but structured smoking cessation advice (according to the standards of the Tobacco Study Group of the Catalan Society of Family Medicine), will be given in both arms.

Also known as: Usual care, Intervention arm, No Intervention arm
Spirometry and lifestyle counseling

Intervention group: will be given a brief but structured smoking cessation advice (according to the standards of the Tobacco Study Group of the Catalan Society of Family Medicine) together with a detailed and structured discussion of the spirometric results.

Also known as: Intervention arm
Spirometry and lifestyle counseling

Eligibility Criteria

Age35 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult smoker subjects aged between 35 and 70 years

You may not qualify if:

  • Previous antecedents of any respiratory disease
  • Suffering of any chronic or terminal disorder
  • Counterindication to undertake spirometry or that may hinder the performance of the spirometry test

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jordi Gol i Gurina Foundation

Barcelona, 08007, Spain

Location

Related Publications (3)

  • Martin-Lujan F, Basora-Gallisa J, Villalobos F, Martin-Vergara N, Aparicio-Llopis E, Pascual-Palacios I, Santigosa-Ayala A, Catalin RE, Rey-Renones C, Sola R; ESPITAP Study Group Investigators. Effectiveness of a motivational intervention based on spirometry results to achieve smoking cessation in primary healthcare patients: randomised, parallel, controlled multicentre study. J Epidemiol Community Health. 2021 Oct;75(10):1001-1009. doi: 10.1136/jech-2020-216219. Epub 2021 Apr 21.

  • Sorli-Aguilar M, Martin-Lujan F, Flores-Mateo G, Jardi-Pinana C, Aparicio-Llopis E, Basora-Gallisa J, Sola-Alberich R; ESPITAP Study Group investigators. Adiposity markers and lung function in smokers: a cross-sectional study in a Mediterranean population. BMC Pulm Med. 2016 Dec 9;16(1):178. doi: 10.1186/s12890-016-0341-y.

  • Martin-Lujan F, Pinol-Moreso JL, Martin-Vergara N, Basora-Gallisa J, Pascual-Palacios I, Sagarra-Alamo R, Llopis EA, Basora-Gallisa MT, Pedret-Llaberia R; ESPITAP Study Group investigators. Effectiveness of a structured motivational intervention including smoking cessation advice and spirometry information in the primary care setting: the ESPITAP study. BMC Public Health. 2011 Nov 11;11:859. doi: 10.1186/1471-2458-11-859.

MeSH Terms

Conditions

Smoking Cessation

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Study Officials

  • Francisco Martín-Luján, MD

    Catalan Institute of Health

    PRINCIPAL INVESTIGATOR
  • Josep L Piñol-Moreso, PhD

    Catalan Institute of Health

    STUDY DIRECTOR
  • Josep Basora-Gallisà, MD

    Catalan Institute of Health

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 2, 2010

First Posted

September 3, 2010

Study Start

June 1, 2008

Primary Completion

June 1, 2010

Study Completion

July 1, 2011

Last Updated

February 27, 2023

Record last verified: 2023-02

Locations