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

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: October 2012

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.

Interventions

  • 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.
  • 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.
  • 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.
  • 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.

Arms, Groups and Cohorts

  • 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.
  • 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.
  • 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.
  • 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.

Clinical Trial Outcome Measures

Primary 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: 30 months after inclusion
    • 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 Measures

  • 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
    • 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: 30 months after inclusion
    • 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
    • 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
    • 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 16 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University of Tromso
  • Collaborator
    • The Royal Norwegian Ministry of Health
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Inger T Gram, MD, PhD, Principal Investigator, University of Tromso
    • Bjørn Engum, Study Director, University Hospital of North Norway

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