CClinicalTrials.gg
Status unknownNCT03276767Updated Oct 8, 2021

Comparing SMS and E-mail Reminders in an Online Smoking Cessation Intervention

An interventional study of Endre in Nicotine Dependence Tobacco Product, sponsored by University of Oslo. Status unknown at 2 sites in 2 countries. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-10-08.

Sponsored by University of Oslo · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Sep 2021), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
700
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Nicotine Dependence Tobacco Product

Browse trials for

Keywords

  • online intervention
  • e-Health
  • reminder
  • SMS-textmessage
  • e-mail
  • mobile phone
  • cell phone
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

  • Not starting the first treatment session
  • Taking every treatment session on time (no need for reminders, and thus not randomized)
04

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
700 participants (estimated)

Study arms

  • 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.

    Other: Endre

  • Active comparator
    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.

    Other: Endre

Interventions

  • OtherEndre

    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.

05

What researchers measure

Primary outcomes

  1. Quit attempt

    User report a quit attempt

    Time frame: Within 6 weeks after starting the first session of the intervention

Secondary outcomes

  1. Number of sessions completed

    Counted from after first reminder until reported quitting or study dropout (a unique session is made available each day)

    Time frame: Within 6 weeks after starting the first session of the intervention

  2. Number of sessions started after first reminder

    Counted from after first reminder until reported quitting or study dropout (a unique session is made available each day)

    Time frame: Within 6 weeks after starting the first session of the intervention

06

Study locations

1 of 2 sites recruiting
  • Department of Addictology, 1st Faculty of Medicine, Charles University
    Praha, Czechia
    Not yet recruiting
  • The Norwegian Centre for Addiction Research
    Oslo, Norway
    Recruiting
07

References and documents

Publications

  • 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. PubMed 27354373 ↗
  • 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. PubMed 35302945 ↗

Related links

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT03276767
Lead sponsor
University of Oslo
Collaborators
The Research Council of Norway, Charles University, Czech Republic
Responsible party
Håvar Brendryen (Senior Research Scientist, University of Oslo) — Principal investigator
First posted
Sep 8, 2017
Start date
Sep 12, 2017
Primary completion
Oct 1, 2022 (estimated)
Completion
Oct 1, 2022 (estimated)
Last update
Oct 8, 2021

Study contacts

Håvar Brendryen, PhD
Contact
brendryen@gmail.com
99521714 ext. +47
Håvar Brendryen, PhD
principal investigator · University of Oslo

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion