Clinical trial NCT03276767: Comparing SMS and E-mail Reminders in an Online Smoking Cessation Intervention
Official title: An RCT Comparing Reminders Sendt by SMS or by E-mail in an Online Smoking Cessation Intervention
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Nicotine Dependence Tobacco Product
Keywords: online intervention
e-Health
reminder
SMS-textmessage
e-mail
mobile phone
cell phone
Lead sponsor: University of Oslo
Sponsor class: OTHER
Collaborators: name: The Research Council of Norway
name: Charles University, Czech Republic
First posted: 2017-09-08
Enrollment: 700
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants receive one out of two versions of a web-based smoking cessation program. The only difference between the two versions is the medium of the reminder: either SMS-textmessage or e-mail.
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Quit attempt
timeFrame: Within 6 weeks after starting the first session of the intervention
Secondary outcomes:
measure: Number of sessions completed
timeFrame: Within 6 weeks after starting the first session of the intervention
measure: Number of sessions started after first reminder
timeFrame: Within 6 weeks after starting the first session of the intervention
Other outcomes:
Locations:
city: Praha
country: Czechia
facility: Department of Addictology, 1st Faculty of Medicine, Charles University
city: Oslo
country: Norway
facility: The Norwegian Centre for Addiction Research
Study officials:
affiliation: University of Oslo
name: Håvar Brendryen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.