Comparing SMS and E-mail Reminders in an Online Smoking Cessation Intervention
Primary Purpose
Nicotine Dependence Tobacco Product
Status
Unknown status
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Endre
Sponsored by
About this trial
This is an interventional prevention trial for Nicotine Dependence Tobacco Product focused on measuring online intervention, e-Health, reminder, SMS-textmessage, e-mail, mobile phone, cell phone
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)
Sites / Locations
- Department of Addictology, 1st Faculty of Medicine, Charles University
- The Norwegian Centre for Addiction ResearchRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Online intervention with SMS reminder
Online intervention with e-mail reminder
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Quit attempt
User report a quit attempt
Secondary Outcome Measures
Number of sessions completed
Counted from after first reminder until reported quitting or study dropout (a unique session is made available each day)
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)
Full Information
NCT ID
NCT03276767
First Posted
September 7, 2017
Last Updated
September 30, 2021
Sponsor
University of Oslo
Collaborators
The Research Council of Norway, Charles University, Czech Republic
1. Study Identification
Unique Protocol Identification Number
NCT03276767
Brief Title
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
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 12, 2017 (Actual)
Primary Completion Date
October 1, 2022 (Anticipated)
Study Completion Date
October 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Oslo
Collaborators
The Research Council of Norway, Charles University, Czech Republic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nicotine Dependence Tobacco Product
Keywords
online intervention, e-Health, reminder, SMS-textmessage, e-mail, mobile phone, cell phone
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Masking Description
The recruitment procedure and the treatment is fully automated and delivered by web, e-mail and SMS-textmessages - i.e., the participant is not contacted by any care providers, investigators or assessors during recruitment or treatment.
Allocation
Randomized
Enrollment
700 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Online intervention with SMS reminder
Arm Type
Experimental
Arm Description
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.
Arm Title
Online intervention with e-mail reminder
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Endre
Intervention Description
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.
Primary Outcome Measure Information:
Title
Quit attempt
Description
User report a quit attempt
Time Frame
Within 6 weeks after starting the first session of the intervention
Secondary Outcome Measure Information:
Title
Number of sessions completed
Description
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
Title
Number of sessions started after first reminder
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Håvar Brendryen, PhD
Phone
99521714
Ext
+47
Email
brendryen@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Håvar Brendryen, PhD
Organizational Affiliation
University of Oslo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Addictology, 1st Faculty of Medicine, Charles University
City
Praha
Country
Czechia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Roman Gabrhelík, PhD
Email
gabrhelik@adiktologie.cz
Facility Name
The Norwegian Centre for Addiction Research
City
Oslo
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Håvar Brendryen, PhD
Phone
99521714
Ext
+47
Email
brendryen@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
27354373
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.
Results Reference
background
PubMed Identifier
35302945
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.
Results Reference
derived
Links:
URL
https://www.sv.uio.no/psi/english/people/aca/haavabre/index.html
Description
Web page of PI
Learn more about this trial
Comparing SMS and E-mail Reminders in an Online Smoking Cessation Intervention
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