Skip to content

Effectiveness of Regular Reporting of Spirometric Results on Smoking Quit Rate.

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.

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01296295
Acronym
ESPIROTAB
Enrollment
466
Registered
2011-02-15
Start date
2005-01-31
Completion date
2011-03-31
Last updated
2011-02-15

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

Conditions

COPD, Smoking Cessation

Keywords

smoking cessation advice, spirometry, primary health care

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 .

Detailed description

Design: Intervention study with two randomized arms in 5 primary care centers of two health areas. Study population: 466 smokers over the age of 18 consulting their primary care physician for any reason and who do not fulfil the exclusion criteria. Measurements and interventions: The study data will be collected using a structured questionnaire and data collection sheets specifically designed for the study The structured questionnaire will include the following data: sociodemographics, clinical history, smoking habit, respiratory symptomatology, smoking dependence test and smoking cessation motivation test. The data collection sheets will include information related to the spirometric results, peak expiratory flow rate and the carbon monoxide test when performed. On visit 0, the primary care physician will give a brief structured smoking cessation advice to all patients combined with a detailed and structured discussion of the spirometric results. After this visit the patients will be randomised in two arms (control and intervention groups). Randomisation will be performed using a computer programme. Randomisation will be carried out by the Coordinating Centre. Both groups will be followed up by telephone at three (visit 1) and six months (visit 2) and at one-year (visit 3) and two-year(visit 4). During the follow up visits brief structured smoking cessation advice will be reinforced in the control group but the spirometric results will not be discussed. In the intervention group brief structured smoking cessation advice will be reinforced with a detailed structured reminder discussion of the results obtained from the spyrometry of visit 0. Follow up visits 1 and 2 will be undertaken by telephone and the patients will be asked about their smoking habit and will be given a brief questionnaire. One month before visits 3 and 4 both groups will undergo the same series of tests performed prior to visit 0 with the exception of the peak expiratory flow rate. Spirometry will be done only in the intervention group. On visits 3 and 4, the same intervention will be done. On both visits 3 and 4 all the participants who report smoking withdrawal will undergo the carbon monoxide test.

Interventions

BEHAVIORALLifestyle counseling and spirometry

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.

Brief smoking cessation advice

Sponsors

Catalan Institute of Health
CollaboratorOTHER_GOV
Research Support Unit Metropolitana Nord, Barcelona, Spain
CollaboratorUNKNOWN
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* All adult smoker population over the age of 18 years attended by their primary care physician for any reason and who do not fulfil

Design outcomes

Primary

MeasureTime frameDescription
Smoking abstinence: self reported abstinence (12 or more months smoking free.24 months after last recruitmentSmoking cessation confirmed by air carbon monoxide concentration. Safety Issue?: (FDAAA) No

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 28, 2026