Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT01194596 |
| Other study ID # |
4R07/040 |
| Secondary ID |
Jordi Gol i Guri |
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 2008 |
| Est. completion date |
July 2011 |
Study information
| Verified date |
February 2023 |
| Source |
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
Main objective: To evaluate the effectiveness of smoking cessation advice combined with a
detailed discussion of the spirometric results with the primary care practitioner on the
smoking habit in adult smokers.
Methodology:
Design: Intervention study using a randomised control group. Setting: 12 primary care centres
of two health areas. Participants: 600 smokers, aged 35 to 70 years, seeking medical advice
from their primary care practitioner (GP) for any given reason (selection visit), excluding
those patients with Chronic Obstructive Pulmonary Disease (COPD).
Measurements and interventions: In the selection visit, all participants will be required to
undergo a series of tests that will include spirometry, tobacco dependence test, a test to
measure the motivation to stop smoking and a structured questionnaire on sociodemographic
data, smoking habit, respiratory symptomatology, etc. Based on the spirometric results,
patients presenting airflow limitation will be excluded.
Randomisation will be performed using a computer programme. Randomisation will be carried out
by the Coordinating Centre.
All other patients will be scheduled for another visit with their primary care practitioner
one month later. In this visit (visit 1) and depending on the randomisation into 2 groups,
one group will be given brief but structured smoking cessation advice together with a
detailed and structured discussion of the spirometric results while the second group will
also be given the same brief smoking cessation advice but without discussing the spirometric
results. Both groups will be scheduled for a visit at 6 months (visit 2), and at 1 year
(visit 3). During visit 2, the patient will be asked about his or her smoking habit. One
month before visit 3, patients will be required to undergo again the series of tests
performed prior to visit 1. In visit 3, all those patients who claim to have stopped smoking
will be required to take a carbon monoxide test.
