- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01103427
Usefulness of Supportive SMS in Addition to an Internet Based Quit Smoking Program (Www.Slutta.no)
December 16, 2013 updated by: University of Tromso
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
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.
Study Overview
Status
Completed
Conditions
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.
Study Type
Interventional
Enrollment (Actual)
4300
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Tromsø, Norway, 9038
- University Hospital of North Norway
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
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 Names:
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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.
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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 Names:
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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.
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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 Names:
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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.
|
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 Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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: 30 months after inclusion
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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).
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30 months after inclusion
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Comparison between the arms of the trial regarding visits, time logged in, used elements of the website and overall adherence period.
Time Frame: 30 months after inclusion
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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.
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30 months after inclusion
|
Comparison between the arms of the trial regarding satisfaction with website and mobile text messages at the time of the 4 questionnaires
Time Frame: 30 months after inclusion
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The 4 questionnaires comprise questions regarding satisfaction with website or text messages for the different arms depending om which device they have been utilizing.
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30 months after inclusion
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28 days of continuous smoking prevalence at 6 months after selfreported smoking cessation date
Time Frame: 6 months after selfreported smoking cessation date
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Comparison between the four arms regarding self-reported 28 days continuous smoking abstinence through questionnaire
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6 months after selfreported smoking cessation date
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Selfreported involvement in any vehicle crashes during the last 6 months
Time Frame: 6 months after selfreported smoking cessation date
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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.
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6 months after selfreported smoking cessation date
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Inger T Gram, MD, PhD, University of Tromso
- Study Director: Bjørn Engum, University Hospital of North Norway
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2010
Primary Completion (Actual)
October 1, 2012
Study Completion (Actual)
October 1, 2012
Study Registration Dates
First Submitted
April 13, 2010
First Submitted That Met QC Criteria
April 13, 2010
First Posted (Estimate)
April 14, 2010
Study Record Updates
Last Update Posted (Estimate)
December 17, 2013
Last Update Submitted That Met QC Criteria
December 16, 2013
Last Verified
December 1, 2013
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- TFP-743-08
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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