Optimizing Text Messaging to Improve Adherence to Web-Based Cessation Treatment

Smoking Cessation Clinical Trial

Official title:

Optimizing Text Messaging to Improve Adherence to Web-Based Cessation Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02585206
• Other study ID #: 1R01DA038139
• Status: Completed
• Phase: N/A
• Start date: March 29, 2018
• Est. completion date: July 10, 2020

Study information

• Verified date: February 2021
• Source: Truth Initiative
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is comprised of 2 phases to study the impact of a text message system on overall adherence to a web-based smoking cessation program. Phase I uses a full factorial design to identify the most optimal text message intervention to maximize adherence to the BecomeAnEX.org smoking cessation program. Phase II is a randomized controlled trial that compares regular BecomeAnEX users to those who will receive the optimized text message intervention (from Phase I) in conjunction with BecomeAnEX for impact on long-term abstinence.

Description:

This study is comprised of 2 active phases, all conducted with registered users on BecomeAnEX.org, a well-established smoking cessation website.

Phase I involves the initial development and optimization of the text message intervention. The investigators will examine the impact of 4 experimental text message intervention features on smokers' adherence to a web-based cessation intervention during the first 3 months of program enrollment. The investigators will utilize a full factorial design where participants will be randomized to 1 of 2 levels of each of the following features: 1) personalization (yes/no), 2) integration (yes/no), 3) dynamic tailoring (yes/no), and 4) message intensity (standard vs. decreasing). The primary outcome in Phase I will be a composite metric of utilization.

Phase II involves a 2-arm randomized trial that compares WEB alone to WEB plus the text message intervention from Phase I that yields optimal adherence (WEB+OA_TXT). The randomized trial will use a repeated measures design, with assessments at baseline, 3, 9, and 15 months. Follow-ups at 3, 9, and 15 months correspond to 0, 6, and 12 months post-treatment. The primary outcome is 30-day point prevalence abstinence (ppa) at 9-months. The investigators will assess and validate smoking status at all follow-ups. Other outcomes include motivation to quit, quit attempts, and continuous abstinence.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1485
• Est. completion date: July 10, 2020
• Est. primary completion date: December 19, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• US residency

• Current smoker

• Access to and willingness to receive text messages on a mobile phone

• Access to Internet

• Access to and willingness to receive email communication from study personnel

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

Behavioral:
• Personalization
Phase I Factor Personalized text messages using the participant's username and gender ("Check out the EX Community for tips/support from other men who have quit. They've been there and can help you do this, QuitForever!"). Both data points will be pulled from BecomeAnEX registration data.
• Integration
Phase I Factor Interactive messages to facilitate engagement via text with the 6 interactive intervention components of the BecomeAnEX web intervention: Set your quit date Cigarette tracker Beat your smoking triggers Build your support system Choose a quit smoking aid Community Integration will allow interaction with the web-based program via text message; for example, when a user sets a quit date via the website, it will trigger text messages tailored to the quit date; likewise, if a user sets a quit date via the text system, it will be populated in the website and drive the user experience online.
• Dynamic Tailoring
Individually tailored message to remind/reinforce users about BecomeAnEX information/tools they have already used, or to prompt users to take actions they have not yet taken.
• Message Intensity
Phase I Factor Varying levels of text message intensity over a 12-week period.
• Optimal-Adherence Text
Optimal-adherence text message intervention developed in Phase I

Locations

Country	Name	City	State
United States	Truth Initiative	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Truth Initiative

Country where clinical trial is conducted

United States, 

References & Publications (1)

Graham AL, Jacobs MA, Cohn AM, Cha S, Abroms LC, Papandonatos GD, Whittaker R. Optimising text messaging to improve adherence to web-based smoking cessation treatment: a randomised control trial protocol. BMJ Open. 2016 Mar 30;6(3):e010687. doi: 10.1136/bmjopen-2015-010687. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Phase I - Composite adherence metric	The investigators will create a composite metric of adherence for each Phase I participant using a weighted sum of their total number of number of visits, as well as of their page views, time on site, and use of the 6 interactive components of the site per visit during 3 months post-enrollment.	3 months
Primary	Phase II - 30-day point prevalence abstinence	Self-reported 30-day point prevalence abstinence at 9 months post randomization	9 months post randomization
Secondary	Phase II - 30day point prevalence abstinence	Self-reported 30-day point prevalence abstinence at 3 months post randomization	3 months post randomization
Secondary	Phase II - 30day point prevalence abstinence	Self-reported 30-day point prevalence abstinence at 15 months post randomization	15 months post randomization