Usefulness of Supportive SMS in Addition to an Internet Based Quit Smoking Program (Www.Slutta.no)
16. desember 2013 oppdatert av: 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.
Studieoversikt
Status
Fullført
Forhold
Detaljert 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.
Studietype
Intervensjonell
Registrering (Faktiske)
4300
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
-
Tromsø, Norge, 9038
- University Hospital of North Norway
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
16 år og eldre (Barn, Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
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.
|
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 navn:
|
|
Eksperimentell: 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.
|
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 navn:
|
|
Eksperimentell: 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.
|
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 navn:
|
|
Eksperimentell: 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.
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
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
|
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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
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
|
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
|
|
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
|
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
|
|
28 days of continuous smoking prevalence at 6 months after selfreported smoking cessation date
Tidsramme: 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
|
|
Selfreported involvement in any vehicle crashes during the last 6 months
Tidsramme: 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.
|
6 months after selfreported smoking cessation date
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Inger T Gram, MD, PhD, University of Tromso
- Studieleder: Bjørn Engum, University Hospital of North Norway
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. mai 2010
Primær fullføring (Faktiske)
1. oktober 2012
Studiet fullført (Faktiske)
1. oktober 2012
Datoer for studieregistrering
Først innsendt
13. april 2010
Først innsendt som oppfylte QC-kriteriene
13. april 2010
Først lagt ut (Anslag)
14. april 2010
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
17. desember 2013
Siste oppdatering sendt inn som oppfylte QC-kriteriene
16. desember 2013
Sist bekreftet
1. desember 2013
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- TFP-743-08
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .