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.

NCT02153047 | Completed

• 1 other identifier: PI11/01962
• Study Type: interventional
• Target: 1,100
• Locations: 1 country
• Sites: 1

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

Conditions

Smoking Cessation

Keywords

Smoking cessation; Spirometry; Primary health care

Outcome Measures

Primary Outcomes (1)

• Cessation of tobacco consumption at 12 months.

  12 months

Secondary Outcomes (1)

• Smoking reduction: self reported reduction

  12 Months

Study Arms (2)

Spirometry

EXPERIMENTAL

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)

Behavioral: Spirometry

Brief smoking cessation advice

NO INTERVENTION

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

Spirometry BEHAVIORAL

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)

Spirometry

Eligibility Criteria

• Age: 35 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina: lead
• Preventive Services and Health Promotion Research Network: collaborator
• Catalan Institute of Health: collaborator

Study Sites (1)

Jordi Gol i Gurina Foundation

Barcelona, 08007, Spain

Location

Related Publications (2)

• Martin-Lujan F, Santigosa-Ayala A, Palleja-Millan M, Rey-Renones C, Villalobos F, Sola R; researchers of the RESET study. Effectiveness of the spirometry-based motivational intervention to quit smoking: RESET randomised trial. Eur J Gen Pract. 2023 Dec;29(1):2276764. doi: 10.1080/13814788.2023.2276764. Epub 2023 Nov 7.

  PMID: 37933978 DERIVED

• Martin-Lujan F, Santigosa-Ayala A, Pinol-Moreso JL, Sorli-Aguilar M, Flores-Mateo G, Blade-Creixenti J, Basora-Gallisa J, Sola-Alberich R; RESET Study Group investigators. 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: the RESET study protocol. BMC Fam Pract. 2016 Feb 4;17:15. doi: 10.1186/s12875-016-0415-1.

  PMID: 26846522 DERIVED

MeSH Terms

Conditions

Smoking Cessation

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Study Officials

• Antoni Santigosa-Ayala, MD

  Catalan Institute of Health

  PRINCIPAL INVESTIGATOR

• Francisco Martín-Luján, PhD

  Catalan Institute of Health

  STUDY DIRECTOR

• Rosa Sola-Alberich, MD

  Catalan Institute of Health

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2014
• First Posted: June 2, 2014
• Study Start: November 1, 2011
• Primary Completion: November 1, 2013
• Study Completion: June 1, 2023
• Last Updated: May 8, 2024

Record last verified: 2024-03

Locations

ES (1)