NCT01296295

Brief Summary

The purpose of this study is to evaluate the effectiveness of regular reporting of spirometric results combined with smoking cessation advice on smoking quit rate in adult smokers in primary care. Hypothesis: In adult smokers, regular reporting of spirometric test results in addition with smoking cessation advice will increase smoking quit rate. Expected outcome: increase of smoking cessation rate .

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
466

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2005

Longer than P75 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

January 1, 2005

Completed
5.6 years until next milestone

First Submitted

Initial submission to the registry

July 30, 2010

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
3 months until next milestone

First Posted

Study publicly available on registry

February 15, 2011

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
Last Updated

February 15, 2011

Status Verified

February 1, 2011

Enrollment Period

5.9 years

First QC Date

July 30, 2010

Last Update Submit

February 13, 2011

Conditions

Smoking CessationCOPD

Keywords

smoking cessation advicespirometryprimary health care

Outcome Measures

Primary Outcomes (1)

  • Smoking abstinence: self reported abstinence (12 or more months smoking free.

    Smoking cessation confirmed by air carbon monoxide concentration. Safety Issue?: (FDAAA) No

    24 months after last recruitment

Study Arms (2)

Spirometry and lifestyle counseling

EXPERIMENTAL

Intervention group: The intervention is to give brief structured smoking cessation advice combined with a detailed and structured discussion of the spirometric results.

Behavioral: Lifestyle counseling and spirometry

Lifestyle counseling

NO INTERVENTION

No intervention group: the patients of the control group will receive a brief structured smoking cessation advice.

Behavioral: Smoking cessation advice

Interventions

Lifestyle counseling and spirometryBEHAVIORAL

The patients of the intervention group will be given a brief structured smoking cessation advice by their primary care physician combined with a detailed and structured discussion of the spirometry results.

Spirometry and lifestyle counseling
Smoking cessation adviceBEHAVIORAL

Brief smoking cessation advice

Lifestyle counseling

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • Previous diagnosis of COPD by spirometry.
  • Patients contraindicated to undertake spirometry.
  • Patients without a telephone.
  • Patients with communication difficulties: cognitive and/or sensorial deterioration, language.
  • Patients with severe disease of poor prognosis (life expectancy of less than one year).
  • Patients with another respiratory disease: asthma, COPD, neoplasm of the respiratory tract, pulmonary thromboembolism, pulmonary tuberculosis, interstitial diseases.
  • Patients who do not give written informed consent to participate in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jordi Gol i Gurina Foundation

Barcelona, Barcelona, Spain

Location

Related Publications (1)

  • Rodriguez-Alvarez M, Toran-Monserrat P, Munoz-Ortiz L, Negrete-Palma A, Montero-Alia JJ, Jimenez-Gonzalez M, Zurilla-Leonarte E, Marina-Ortega V, Olle-Borque M, Valentin-Moya E, Cortada-Cabrera A, Tena-Domingo A, Martinez-Gonzalez S, Vila-Palau V, Ramos-Ordonez A, Rotllant-Estelrich G, Forcada-Vega C, Borrell-Thio E. Effectiveness of regular reporting of spirometric results combined with a smoking cessation advice by a primary care physician on smoking quit rate in adult smokers: a randomized controlled trial. ESPIROTAB study. BMC Fam Pract. 2011 Jun 28;12:61. doi: 10.1186/1471-2296-12-61.

    PMID: 21708047DERIVED

MeSH Terms

Conditions

Smoking CessationPulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Health BehaviorBehaviorLung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Mar Rodriguez

    Institut Catalá de la Salut

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

July 30, 2010

First Posted

February 15, 2011

Study Start

January 1, 2005

Primary Completion

December 1, 2010

Study Completion

March 1, 2011

Last Updated

February 15, 2011

Record last verified: 2011-02

Locations

ES(1)