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- Klinische proef 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
Studie Overzicht
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Verwacht)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Håvar Brendryen, PhD
- Telefoonnummer: +47 99521714
- E-mail: brendryen@gmail.com
Studie Locaties
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Oslo, Noorwegen
- Werving
- The Norwegian Centre for Addiction Research
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Contact:
- Håvar Brendryen, PhD
- Telefoonnummer: +47 99521714
- E-mail: brendryen@gmail.com
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Praha, Tsjechië
- Nog niet aan het werven
- Department of Addictology, 1st Faculty of Medicine, Charles University
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Contact:
- Roman Gabrhelík, PhD
- E-mail: gabrhelik@adiktologie.cz
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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)
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: 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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Actieve vergelijker: 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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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Stoppen met poging
Tijdsspanne: Binnen 6 weken na aanvang van de eerste sessie van de interventie
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Gebruiker meldt een stoppoging
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Binnen 6 weken na aanvang van de eerste sessie van de interventie
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Number of sessions completed
Tijdsspanne: 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
Tijdsspanne: 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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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Håvar Brendryen, PhD, University of Oslo
Publicaties en nuttige links
Algemene publicaties
- 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.
Nuttige links
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Verwacht)
Studie voltooiing (Verwacht)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
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Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- NFR 228158/H10-C
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
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