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Multicentric Randomized Clinical Trial to Evaluate the Long-term Effectiveness of a Motivational Intervention Against Smoking, Based on the Information Obtained From Spirometry in Primary Care.

Multicentric Randomized Clinical Trial to Evaluate the Long-term Effectiveness of a Motivational Intervention Against Smoking, Based on the Information Obtained From Spirometry in Primary Care.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02153047
Acronym
RESET-ESPITAP2
Enrollment
1100
Registered
2014-06-02
Start date
2011-11-30
Completion date
2023-06-30
Last updated
2024-05-08

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

Conditions

Smoking Cessation

Keywords

Smoking cessation, Spirometry, Primary health care

Brief summary

There is controversy about the effectiveness of interventions based on spirometry for smoking cessation. The investigators want to evaluate the effectiveness of motivational intervention performed by a doctor to obtain abstinence compared with normal practice in primary care. This study, is the second half of what was began with ESPITAP study

Detailed description

Design: Multicentric randomized clinical trial with two groups. Setting: 20 primary care centers inTarragona. Subjects: 1100 active smokers (consumption\>10 packs/year) aged 35-70, seeking medical advice for any reason, with no exclusion criteria, will be randomized to receive the intervention or not. Intervention: A 20-minutes visit with details of the spirometry data (values of respiratory capacity and volumes referring on the theoretical). The lung age index will be reported compared to chronological age to illustrate lung damage suffered as a result of tobacco consumption. Measurements: Basal Spirometry. Structured questionnaire interviewed in the center at 0 and 12 months and telephone interview at 3 and 6 months. At 12 months, patients who stopped smoking will perform a CO test and if the CO exhaled will be \<10ppm abstinence will be verified by determination of urinary cotinine. Primary endpoint: Cessation of tobacco consumption at 12 months. Analysis: Data will be analyzed in the intent to treat, the unit of analysis will be the smoker. Expected Results: smoking cessation in the intervention group will exceed at least 5% the achieved by normal practice in primary care.

Interventions

BEHAVIORALSpirometry

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 20-minutes visit with details of the spirometry data (values of respiratory capacity and volumes referring on the theoretical)

Sponsors

Preventive Services and Health Promotion Research Network
CollaboratorOTHER
Catalan Institute of Health
CollaboratorOTHER_GOV
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
35 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

* Active smokers (consumption\>10 packs/year)

Exclusion criteria

* Active respiratory disease * Practice of an espirometry on 12 months before * Suffering of any chronic or terminal disorder * Counterindication to undertake spirometry or that may hinder the performance of the spirometry test

Design outcomes

Primary

MeasureTime frame
Cessation of tobacco consumption at 12 months.12 months

Secondary

MeasureTime frameDescription
Smoking reduction: self reported reduction12 MonthsSmoking reduction by self reported reduction

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 18, 2026