Usefulness of Supportive SMS in Addition to an Internet Based Quit Smoking Program (Www.Slutta.no)
16 december 2013 bijgewerkt door: 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.
Studie Overzicht
Toestand
Voltooid
Conditie
Gedetailleerde beschrijving
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.
Studietype
Ingrijpend
Inschrijving (Werkelijk)
4300
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Tromsø, Noorwegen, 9038
- University Hospital of North Norway
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
16 jaar en ouder (Kind, Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Dubbele
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Actieve vergelijker: 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.
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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.
Andere namen:
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Experimenteel: 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.
Andere namen:
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Experimenteel: 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.
Andere namen:
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Experimenteel: 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.
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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.
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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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
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Comparison between the arms of the trial regarding visits, time logged in, used elements of the website and overall adherence period.
Tijdsspanne: 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
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Comparison between the arms of the trial regarding satisfaction with website and mobile text messages at the time of the 4 questionnaires
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Hoofdonderzoeker: Inger T Gram, MD, PhD, University of Tromso
- Studie directeur: Bjørn Engum, University Hospital of North Norway
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 mei 2010
Primaire voltooiing (Werkelijk)
1 oktober 2012
Studie voltooiing (Werkelijk)
1 oktober 2012
Studieregistratiedata
Eerst ingediend
13 april 2010
Eerst ingediend dat voldeed aan de QC-criteria
13 april 2010
Eerst geplaatst (Schatting)
14 april 2010
Updates van studierecords
Laatste update geplaatst (Schatting)
17 december 2013
Laatste update ingediend die voldeed aan QC-criteria
16 december 2013
Laatst geverifieerd
1 december 2013
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Andere studie-ID-nummers
- TFP-743-08
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .