- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT03276767
Comparing SMS and E-mail Reminders in an Online Smoking Cessation Intervention
An RCT Comparing Reminders Sendt by SMS or by E-mail in an Online Smoking Cessation Intervention
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
Web- and mobile phone health behavior change interventions, including smoking cessation programs, offer great promise, but little is known about how such interventions should be designed to increase user engagement. The primary purpose of the current study is to compare the effect of SMS-textmessage vs e-mail reminders on user engagement and proportion of reported quit attempts in an online smoking cessation intervention.
The investigators propose a 2-arm RCT with 700 adult study participants that all receive a best practices web-based smoking cessation program designed for use on smart phones (web-app). The intervention includes a ten day preparation phase, in which participants continue smoking. On the eleventh day (and onward) the user will receive a session in which (s)he is asked whether (s)he has quit smoking or not. If not, the user will receive additional treatment sessions until (s)he reports having quit (or dropped out of the study). Each day (for up to 14 days) a new unique session is assigned to the user. However, if the user does not log on to the web-intervention and starts using the session by noon on the second day after assignment, the user will receive a reminder to do so. When a user is to be sent a reminder for the first time, (s)he will be randomized to either receive such reminders by SMS or by e-mail.
The primary outcome is reporting a quit attempt or not. Secondary outcomes include number web-sessions started and completed and time spent navigating sessions after the first reminder is received.
Studientyp
Einschreibung (Voraussichtlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: Håvar Brendryen, PhD
- Telefonnummer: +47 99521714
- E-Mail: brendryen@gmail.com
Studienorte
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Oslo, Norwegen
- Rekrutierung
- The Norwegian Centre for Addiction Research
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Kontakt:
- Håvar Brendryen, PhD
- Telefonnummer: +47 99521714
- E-Mail: brendryen@gmail.com
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Praha, Tschechien
- Noch keine Rekrutierung
- Department of Addictology, 1st Faculty of Medicine, Charles University
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Kontakt:
- Roman Gabrhelík, PhD
- E-Mail: gabrhelik@adiktologie.cz
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- 18 years or older
- current smoker
- determined to or considering to quit smoking
- provide valid e-mail address
- provide valid norwegian cell phone number
- complete a baseline questionnaire
- start using the intervention (pushing the next page button one time or more on the first session provided)
- has not logged on to any of the online session within noon on the second day after that particular session was made available
Exclusion Criteria:
- Not starting the first treatment session
- Taking every treatment session on time (no need for reminders, and thus not randomized)
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Experimental: Online intervention with SMS reminder
Reminders will be sendt by SMS-TEXTMESSAGE if users of "Endre" does not log on to an assigned online session by noon on the second day.
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The online intervention, "Endre", a digital smoking cessation counsellor that communicates with the user primarily through interactive web-sessions.
Intervention content is tailored based on user input and individual usage pattern.
Up to 14 unique sessions is assigned to the users during the study period, one each day.
If a user does not start a session by noon on the second day a reminder will be sendt.
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Aktiver Komparator: Online intervention with e-mail reminder
Reminder will be sendt by E-MAIL if users of "Endre" does not log on to an assigned online session by noon on the second day.
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The online intervention, "Endre", a digital smoking cessation counsellor that communicates with the user primarily through interactive web-sessions.
Intervention content is tailored based on user input and individual usage pattern.
Up to 14 unique sessions is assigned to the users during the study period, one each day.
If a user does not start a session by noon on the second day a reminder will be sendt.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Versuch abbrechen
Zeitfenster: Innerhalb von 6 Wochen nach Beginn der ersten Interventionssitzung
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Benutzer meldet einen Beendigungsversuch
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Innerhalb von 6 Wochen nach Beginn der ersten Interventionssitzung
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Number of sessions completed
Zeitfenster: Within 6 weeks after starting the first session of the intervention
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Counted from after first reminder until reported quitting or study dropout (a unique session is made available each day)
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Within 6 weeks after starting the first session of the intervention
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Number of sessions started after first reminder
Zeitfenster: Within 6 weeks after starting the first session of the intervention
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Counted from after first reminder until reported quitting or study dropout (a unique session is made available each day)
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Within 6 weeks after starting the first session of the intervention
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Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Håvar Brendryen, PhD, University of Oslo
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
- Holter MT, Johansen A, Brendryen H. How a Fully Automated eHealth Program Simulates Three Therapeutic Processes: A Case Study. J Med Internet Res. 2016 Jun 28;18(6):e176. doi: 10.2196/jmir.5415.
- Kulhanek A, Lukavska K, Gabrhelik R, Novak D, Burda V, Prokop J, Holter MTS, Brendryen H. Comparing Reminders Sent via SMS Text Messaging and Email for Improving Adherence to an Electronic Health Program: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2022 Mar 18;10(3):e31040. doi: 10.2196/31040.
Nützliche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Voraussichtlich)
Studienabschluss (Voraussichtlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- NFR 228158/H10-C
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