Usefulness of Supportive SMS in Addition to an Internet Based Quit Smoking Program (Www.Slutta.no)
16. december 2013 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
4300
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Tromsø, Norge, 9038
- University Hospital of North Norway
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
16 år og ældre (Barn, Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Aktiv komparator: 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.
Andre navne:
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Eksperimentel: 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.
Andre navne:
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Eksperimentel: 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.
Andre navne:
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Eksperimentel: 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.
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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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
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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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.
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Inger T Gram, MD, PhD, University of Tromso
- Studieleder: Bjørn Engum, University Hospital of North Norway
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. maj 2010
Primær færdiggørelse (Faktiske)
1. oktober 2012
Studieafslutning (Faktiske)
1. oktober 2012
Datoer for studieregistrering
Først indsendt
13. april 2010
Først indsendt, der opfyldte QC-kriterier
13. april 2010
Først opslået (Skøn)
14. april 2010
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
17. december 2013
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
16. december 2013
Sidst verificeret
1. december 2013
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- TFP-743-08
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Internet-based behavioral coaching
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