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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT01734421
Other study ID # PI12/01977
Secondary ID
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


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
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