Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 75 of 663 for:    SMS

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03276767
Recruitment Status : Recruiting
First Posted : September 8, 2017
Last Update Posted : May 14, 2018
Sponsor:
Collaborators:
The Research Council of Norway
Charles University, Czech Republic
Information provided by (Responsible Party):
Håvar Brendryen, University of Oslo

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.

Condition or disease Intervention/treatment Phase
Nicotine Dependence Tobacco Product Other: Endre Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 700 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
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.
Primary Purpose: Prevention
Official Title: An RCT Comparing Reminders Sendt by SMS or by E-mail in an Online Smoking Cessation Intervention
Actual Study Start Date : September 12, 2017
Estimated Primary Completion Date : January 1, 2019
Estimated Study Completion Date : January 1, 2019

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Quit attempt [ Time Frame: Within 6 weeks after starting the first session of the intervention ]
    User report a quit attempt


Secondary Outcome Measures :
  1. Number of sessions completed [ Time Frame: Within 6 weeks after starting the first session of the intervention ]
    Counted from after first reminder until reported quitting or study dropout (a unique session is made available each day)

  2. Number of sessions started after first reminder [ Time Frame: Within 6 weeks after starting the first session of the intervention ]
    Counted from after first reminder until reported quitting or study dropout (a unique session is made available each day)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03276767


Contacts
Layout table for location contacts
Contact: Håvar Brendryen, PhD 99521714 ext +47 brendryen@gmail.com

Locations
Layout table for location information
Czechia
Department of Addictology, 1st Faculty of Medicine, Charles University Not yet recruiting
Praha, Czechia
Contact: Roman Gabrhelík, PhD       gabrhelik@adiktologie.cz   
Norway
The Norwegian Centre for Addiction Research Recruiting
Oslo, Norway
Contact: Håvar Brendryen, PhD    99521714 ext +47    brendryen@gmail.com   
Sponsors and Collaborators
University of Oslo
The Research Council of Norway
Charles University, Czech Republic
Investigators
Layout table for investigator information
Principal Investigator: Håvar Brendryen, PhD University of Oslo

Additional Information:
Publications:
Layout table for additonal information
Responsible Party: Håvar Brendryen, Senior Research Scientist, University of Oslo
ClinicalTrials.gov Identifier: NCT03276767     History of Changes
Other Study ID Numbers: NFR 228158/H10-C
First Posted: September 8, 2017    Key Record Dates
Last Update Posted: May 14, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Håvar Brendryen, University of Oslo:
online intervention
e-Health
reminder
SMS-textmessage
e-mail
mobile phone
cell phone
Additional relevant MeSH terms:
Layout table for MeSH terms
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders