Usefulness of Supportive SMS in Addition to an Internet Based Quit Smoking Program (Www.Slutta.no)

Smoking Cessation Clinical Trial

Official title:

Mobile Text Messaging as an Adjunct Function to an Internet-based Smoking Cessation Intervention Implemented in the General Population and in a Health Care Setting

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01103427
• Other study ID #: TFP-743-08
• Status: Completed
• Phase: N/A
• First received: April 13, 2010
• Last updated: December 16, 2013
• Start date: May 2010
• Est. completion date: October 2012

Study information

• Verified date: December 2013
• Source: University of Tromso
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research Ethics
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to investigate the effectiveness of a smoking cessation intervention delivered through a technological web based platform (www.slutta.no) with or without a supportive SMS function.

Description:

The study has two arms and are conducted in Norwegian. Users who registered with a new username on www.slutta.no, after study start May 12th 2010 and before November 1st 2012, are eligible. All phases of the trial, from randomization and informed consent procedures to data collection, are automated and conducted online. The following inclusion criteria are used: age 16 years or older, access to a mobile phone with a Norwegian phone number and they must submit an informed consent form.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4300
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 16 Years and older

Eligibility

Inclusion Criteria (all arms):

• Aged 16 and older

• Current smoker: Willing to quit smoking within the next 12 weeks

• Former smokers; Having quit smoking within the previous six months

• Having a regular access to Internet

• Having a personal e-mail address

• Having a personal mobile cell phone with a Norwegian number

• Given informed consent

• Can read and understand Norwegian

• Reporting no association with the University Hospital of North Norway (arm1&2)

• Reporting an association with the University Hospital of North Norway (arm3&4)

Exclusion Criteria:

• Less than 16 years of age

• No personal e-mail address

• No personal mobile cell phone

• Not able to give the informed consent

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Smoking
• Smoking Cessation

Intervention

Device:
• Internet-based behavioral coaching
Those in the "active comparator arm" will benefit from automated coaching by e-mails with advice, information and support for smoking cessation. These e-mails will be adapted to their personal profile.
• SMS based coaching
Those in the experimental SMS based coaching arm will benefit from automated coaching by SMS with advice, information and support for smoking cessation. These SMS's will be adapted to their personal profile.
• SMS coaching - UNN recruited
Those in the experimental SMS based coaching arm- UNN recruited - will benefit from automated coaching by SMS with advice, information and support for smoking cessation. These SMS's will be adapted to their personal profile.
• SMS craving function - UNN recruited
Those in the experimental SMS based craving/panic function arm - will in addition to the automated coaching by SMS have a panic/craving SMS function. Thus by sending a SMS they will receive instant advise and support for smoking cessation by SMS.

Locations

Country	Name	City	State
Norway	University Hospital of North Norway	Tromsø

Sponsors (3)

Lead Sponsor	Collaborator
University of Tromso	The Royal Norwegian Ministry of Health, University Hospital of North Norway

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of the percentage of abstinent people between the arms of the trial,1,3,6 and 12 months after self-reported smoking cessation date	The investigators will compare the percentage of smokers who successfully quit. Point prevalence abstinence will be measured (not smoking, event a puff, in the week preceding the questioning).	30 months after inclusion	No
Secondary	Comparison between the arms of the trial regarding visits, time logged in, used elements of the website and overall adherence period.	Number of visits to the website, time logged in, used elements of the website and adherence to the program will be measured utilizing the registrations on the server.	30 months after inclusion	No
Secondary	Comparison between the arms of the trial regarding satisfaction with website and mobile text messages at the time of the 4 questionnaires	The 4 questionnaires comprise questions regarding satisfaction with website or text messages for the different arms depending om which device they have been utilizing.	30 months after inclusion	No
Secondary	28 days of continuous smoking prevalence at 6 months after selfreported smoking cessation date	Comparison between the four arms regarding self-reported 28 days continuous smoking abstinence through questionnaire	6 months after selfreported smoking cessation date	No
Secondary	Selfreported involvement in any vehicle crashes during the last 6 months	Involvement in any vehicle crashes (this is the only rare adverse health effects of using a mobile phone)during the 6 months after selfreported smoking cessation date.	6 months after selfreported smoking cessation date	Yes