Usefulness of Supportive SMS in Addition to an Internet Based Quit Smoking Program (Www.Slutta.no)
16. Dezember 2013 aktualisiert von: 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.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Detaillierte Beschreibung
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.
Studientyp
Interventionell
Einschreibung (Tatsächlich)
4300
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
-
-
-
Tromsø, Norwegen, 9038
- University Hospital of North Norway
-
-
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
16 Jahre und älter (Kind, Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Alle
Beschreibung
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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Doppelt
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Aktiver 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.
Andere Namen:
|
|
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.
|
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:
|
|
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.
|
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:
|
|
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.
Andere Namen:
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
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
Zeitfenster: 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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Comparison between the arms of the trial regarding visits, time logged in, used elements of the website and overall adherence period.
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Ermittler
- Hauptermittler: Inger T Gram, MD, PhD, University of Tromso
- Studienleiter: Bjørn Engum, University Hospital of North Norway
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn
1. Mai 2010
Primärer Abschluss (Tatsächlich)
1. Oktober 2012
Studienabschluss (Tatsächlich)
1. Oktober 2012
Studienanmeldedaten
Zuerst eingereicht
13. April 2010
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
13. April 2010
Zuerst gepostet (Schätzen)
14. April 2010
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
17. Dezember 2013
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
16. Dezember 2013
Zuletzt verifiziert
1. Dezember 2013
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Andere Studien-ID-Nummern
- TFP-743-08
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .