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

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.

Study Overview

• Status: Recruiting
• Conditions: Nicotine Dependence Tobacco Product
• Intervention / Treatment: Other: Endre

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.

• Study Type: Interventional
• Enrollment (Anticipated): 700
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Håvar Brendryen, PhD; Phone Number: +47 99521714; Email: brendryen@gmail.com

Study Locations

• Czechia
  • Praha, Czechia
    • Not yet recruiting
    • Department of Addictology, 1st Faculty of Medicine, Charles University
    • Contact: Roman Gabrhelík, PhD; Email: gabrhelik@adiktologie.cz
• Norway
  • Oslo, Norway
    • Recruiting
    • The Norwegian Centre for Addiction Research
    • Contact: Håvar Brendryen, PhD; Phone Number: +47 99521714; Email: brendryen@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; 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.
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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quit attempt	User report a quit attempt	Within 6 weeks after starting the first session of the intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of sessions completed	Counted from after first reminder until reported quitting or study dropout (a unique session is made available each day)	Within 6 weeks after starting the first session of the intervention
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)	Within 6 weeks after starting the first session of the intervention

Collaborators and Investigators

• Sponsor: University of Oslo
• Collaborators: Charles University, Czech Republic; The Research Council of Norway
• Investigators: Principal Investigator: Håvar Brendryen, PhD, University of Oslo

Publications and helpful links

General 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.
• 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.

Helpful Links

• Web page of PI

Study record dates

Study Major Dates

• Study Start (Actual): September 12, 2017
• Primary Completion (Anticipated): October 1, 2022
• Study Completion (Anticipated): October 1, 2022

Study Registration Dates

• First Submitted: September 7, 2017
• First Submitted That Met QC Criteria: September 7, 2017
• First Posted (Actual): September 8, 2017

Study Record Updates

• Last Update Posted (Actual): October 8, 2021
• Last Update Submitted That Met QC Criteria: September 30, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: online intervention; mobile phone; reminder; cell phone; e-Health; e-mail; SMS-textmessage
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Tobacco Use Disorder
• Other Study ID Numbers: NFR 228158/H10-C

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No