- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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
Studieöversikt
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Förväntat)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Håvar Brendryen, PhD
- Telefonnummer: +47 99521714
- E-post: brendryen@gmail.com
Studieorter
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Oslo, Norge
- Rekrytering
- The Norwegian Centre for Addiction Research
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Kontakt:
- Håvar Brendryen, PhD
- Telefonnummer: +47 99521714
- E-post: brendryen@gmail.com
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Praha, Tjeckien
- Har inte rekryterat ännu
- Department of Addictology, 1st Faculty of Medicine, Charles University
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Kontakt:
- Roman Gabrhelík, PhD
- E-post: gabrhelik@adiktologie.cz
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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)
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Experimentell: 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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Aktiv 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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Avsluta försöket
Tidsram: Inom 6 veckor efter påbörjad första session av interventionen
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Användaren rapporterar ett försök att avsluta
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Inom 6 veckor efter påbörjad första session av interventionen
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Number of sessions completed
Tidsram: 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
Tidsram: 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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Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Håvar Brendryen, PhD, University of Oslo
Publikationer och användbara länkar
Allmänna publikationer
- 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.
Användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- NFR 228158/H10-C
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
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