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

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ClinicalTrials.gov Identifier: NCT01734421
Recruitment Status : Unknown
Verified November 2012 by Jordi Gol i Gurina Foundation.
Recruitment status was:  Not yet recruiting
First Posted : November 27, 2012
Last Update Posted : November 27, 2012
Sponsor:
Collaborator:
Preventive Services and Health Promotion Research Network
Information provided by (Responsible Party):
Jordi Gol i Gurina Foundation

Brief 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.


Condition or disease Intervention/treatment Phase
Smoking Cessation Other: Control group Device: Cell phone Aplication for Smarth Phone Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 604 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacacy of a Mobile Application in the Smoking Cessation Among Young Poeple: Cluster Randomized Trial
Study Start Date : January 2013
Estimated Primary Completion Date : June 2015
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Control group
Habitual deshabituation in the control group following the guidelines of the primary health care institution.
Other: Control group
6-month implementation of recommendations of a Clinical Practice Guideline smoking cessation
Active Comparator: Cell phone Aplication for Smarth Phone
Cell phone 6-month implementation of recommendations of a Clinical Practice Guideline smoking cessation which includes mobile APPs application
Device: Cell phone Aplication for Smarth Phone



Primary Outcome Measures :
  1. Smoking cessation [ Time Frame: Change in smoking status from baseline at 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01734421


Contacts
Contact: Empar Valdivieso López, Nurse +34675783477 evaldivieso.tarte.ics@gencat.cat
Contact: Gemma Flores Mateo, PhD +34626136232 gflores@idiapjgol.org

Locations
Spain
Jordi Gol i Gurina Foundation Not yet recruiting
Barcelona, Spain, 08007
Contact: Gemma Flores Mateo, PhD    +34626136232    gflores@idiapjgol.org   
Principal Investigator: Empar Valdivieso López, Nurse         
Sub-Investigator: Araceli Valverde Trillo, MD         
Sub-Investigator: Gemma Flores Mateo, PhD         
Sub-Investigator: Cristina Rey Reñones, Nurse         
Sub-Investigator: Juan Domingo Molina Gomez, Bsc         
Sponsors and Collaborators
Jordi Gol i Gurina Foundation
Preventive Services and Health Promotion Research Network

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jordi Gol i Gurina Foundation
ClinicalTrials.gov Identifier: NCT01734421     History of Changes
Other Study ID Numbers: PI12/01977
First Posted: November 27, 2012    Key Record Dates
Last Update Posted: November 27, 2012
Last Verified: November 2012

Keywords provided by Jordi Gol i Gurina Foundation:
Smoking cessation
Primary health care
Young people
Cellular phone