Efficacy of a Mobile Application in the Smoking Cessation Among Young People

Smoking Cessation Clinical Trial

— TOBB_STOP  

Official title:

Efficacacy of a Mobile Application in the Smoking Cessation Among Young Poeple: Cluster Randomized Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01734421
• Other study ID #: PI12/01977
• Status: Not yet recruiting
• Phase: N/A
• First received: November 22, 2012
• Last updated: November 26, 2012
• Start date: January 2013
• Est. completion date: December 2015

Study information

• Verified date: November 2012
• Source: Jordi Gol i Gurina Foundation
• Contact: Empar Valdivieso López, Nurse
• Phone: +34675783477
• Email: evaldivieso.tarte.ics[@]gencat.cat
• Is FDA regulated: No
• Health authority: Spain: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

AIM: To assess the efficacy of an intervention based on the specific design and implementation of a mobile application (APP) in order to reduce the prevalence of smoking consumption among young people motivated 18 to 30 years METHODS: Cluster randomised clinical trial. Unit of randomization: Primary Health Care Centers (PHCC). Intention to treat analysis. STUDY POPULATION: Motivated young smokers of 10 or more cigarettes per day aged 18 to 30 years consulting for any reason to PHCC and who provided written informed consent to participate in the trial.

INTERVENTION: 6-month implementation of recommendations of a Clinical Practice Guideline smoking cessation which includes mobile APPs application. Control group: usual care. OUTCOME MEASURES: Abstinence at 12 months confirmed by exhaled air carbon monoxide concentration of less or iqual 10 parts per million in each control.

RESULTS: The application of a smoking cessation intervention with a mobile APPs application will improve the smoking cessation success rate in smokers, besides of their intention or not to give up smoking at baseline.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 604
• Est. completion date: December 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 30 Years

Eligibility

Inclusion Criteria:

• Participant between 18 t0 30 years old smoking 10 or more cigarretes at day

• To have a smarthphone (Android, ios Ihpone, ios Ipad)

• Normal and high motivation for smocking cessation

Exclusion Criteria:

• To have other addictions

• Participants with Blackberry smarthphone

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

Other:
• Control group
6-month implementation of recommendations of a Clinical Practice Guideline smoking cessation

Device:
• Cell phone Aplication for Smarth Phone

Locations

Country	Name	City	State
Spain	Jordi Gol i Gurina Foundation	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Jordi Gol i Gurina Foundation	Preventive Services and Health Promotion Research Network

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Smoking cessation		Change in smoking status from baseline at 6 months	No