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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01103427
Other study ID # TFP-743-08
Secondary ID
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


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
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