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

Nicotine Dependence Tobacco Product Clinical Trial

Official title:

An RCT Comparing Reminders Sendt by SMS or by E-mail in an Online Smoking Cessation Intervention

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03276767
• Other study ID #: NFR 228158/H10-C
• Status: Recruiting
• Phase: N/A
• Start date: September 12, 2017
• Est. completion date: October 1, 2022

Study information

• Verified date: September 2021
• Source: University of Oslo
• Contact: Håvar Brendryen, PhD
• Phone: 99521714
• Email: brendryen[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 700
• Est. completion date: October 1, 2022
• Est. primary completion date: October 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Nicotine Dependence Tobacco Product
• Tobacco Use Disorder

Intervention

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.

Locations

Country	Name	City	State
Czechia	Department of Addictology, 1st Faculty of Medicine, Charles University	Praha
Norway	The Norwegian Centre for Addiction Research	Oslo

Sponsors (3)

Lead Sponsor	Collaborator
University of Oslo	Charles University, Czech Republic, The Research Council of Norway

Countries where clinical trial is conducted

Czechia,  Norway, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quit attempt	User report a quit attempt	Within 6 weeks after starting the first session of the intervention
Secondary	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
Secondary	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

External Links

•   Web page of PI