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

Purpose

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.

Condition	Intervention
Smoking Cessation Smoking	Device: Internet-based behavioral coaching Device: SMS based coaching Device: SMS coaching - UNN recruited Device: SMS craving function - UNN recruited

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

Resource links provided by NLM:

MedlinePlus related topics: Quitting Smoking Smoking Smoking and Youth

U.S. FDA Resources

Further study details as provided by University of Tromso:

Primary Outcome Measures:

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 [ Time Frame: 15 months after inclusion ] [ Designated as safety issue: No ]
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).

Secondary Outcome Measures:

Comparison between the arms of the trial regarding visits, time logged in, used elements of the website and overall adherence period. [ Time Frame: 15 months after inclusion ] [ Designated as safety issue: No ]
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.
Comparison between the arms of the trial regarding satisfaction with website and mobile text messages at the time of the 4 questionnaires [ Time Frame: 15 months after inclusion ] [ Designated as safety issue: No ]
The 4 questionnaires comprise questions regarding satisfaction with website or text messages for the different arms depending om which device they have been utilizing.
28 days of continuous smoking prevalence at 6 months after selfreported smoking cessation date [ Time Frame: 6 months after selfreported smoking cessation date ] [ Designated as safety issue: No ]
Comparison between the four arms regarding self-reported 28 days continuous smoking abstinence through questionnaire
Selfreported involvement in any vehicle crashes during the last 6 months [ Time Frame: 6 months after selfreported smoking cessation date ] [ Designated as safety issue: Yes ]
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.

Estimated Enrollment:	6000
Study Start Date:	May 2010
Estimated Study Completion Date:	May 2013
Estimated Primary Completion Date:	November 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Internet-based coaching . Arm 1. Those in the "active comparator arm" will benefit from automated internet-based coaching. The subjects will be recruited from the general population reporting not to be associated with the University Hospital of North Norway and randomized to arm 1 or 2.	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. Other Name: slutta.no
Experimental: SMS based coaching Arm 2. The subjects will receive automated "coaching"by SMS.The subjects will be recruited from the general population reporting not to be associated with the University Hospital of North Norway and randomized to arm 1 or 2.	Device: 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. Other Name: slutta.no
Experimental: SMS coaching UNN recruited Arm 3.The subjects will be recruited from those reporting to be associated with the University Hospital of North Norway and randomized to arm 3 or 4.	Device: 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. Other Name: slutta.no/unn
Experimental: Craving/Panic function. UNN recruited Arm 4. The subjects will in addition to the automated "coaching"by SMS get a SMS panic/craving function. The subjects will be recruited from subjects reporting to be associated with the University Hospital of North Norway and randomized to arm 3 or 4.	Device: 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. Other Name: slutta.no/unn

Detailed 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.

Eligibility

Ages Eligible for Study:	16 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01103427

Contacts

Contact: Inger T Gram, MD, PhD	1-(808)-454-3662	inger.gram@uit.no
Contact: Olav Nilsen, MSc		olav.nilsen@telemed.no

Locations

Norway
University Hospital of North Norway	Recruiting
Tromsø, Norway, 9038
Contact: Inger T Gram, MD, PhD +4792401177 inger.gram@uit.no
Contact: Olav Nilsen, Msc +4799270738 olav.nilsen@telemed.no
Sub-Investigator: Olav Nilsen, Msc

Sponsors and Collaborators

University of Tromso

The Royal Norwegian Ministry of Health

University Hospital of North Norway

Investigators

Principal Investigator:	Inger T Gram, MD, PhD	University of Tromso
Study Chair:	Toralf Hasvold, MD;PhD	University Hospital of North Norway

More Information

No publications provided

Responsible Party:	University of Tromso
ClinicalTrials.gov Identifier:	NCT01103427 History of Changes
Other Study ID Numbers:	TFP-743-08
Study First Received:	April 13, 2010
Last Updated:	October 24, 2012
Health Authority:	Norway:National Committee for Medical and Health Research Ethics

Keywords provided by University of Tromso:

smoking cessation
telemedicine
smoking
prevention intervention

internet-based
text messages
behavioral

Additional relevant MeSH terms:

Smoking
Habits

ClinicalTrials.gov processed this record on May 23, 2013