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

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Factorial Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Participant)
  • Study Primary Completion Date: July 2020

Detailed 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.

Interventions

  • 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.
  • Behavioral: 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.
  • Behavioral: 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.
  • Behavioral: Message Intensity
    • Phase I Factor Varying levels of text message intensity over a 12-week period.
  • Behavioral: Optimal-Adherence Text
    • Optimal-adherence text message intervention developed in Phase I

Arms, Groups and Cohorts

  • No Intervention: Arm 1
    • All 4 factors off – standard text message program Personalization OFF Integration OFF Dynamic Tailoring OFF Message Intensity OFF
  • Active Comparator: Arm 2
    • Personalization OFF Integration OFF Dynamic Tailoring OFF Message Intensity ON
  • Active Comparator: Arm 3
    • Personalization OFF Integration OFF Dynamic Tailoring ON Message Intensity OFF
  • Active Comparator: Arm 4
    • Personalization OFF Integration OFF Dynamic Tailoring ON Message Intensity ON
  • Active Comparator: Arm 5
    • Personalization OFF Integration ON Dynamic Tailoring OFF Message Intensity OFF
  • Active Comparator: Arm 6
    • Personalization OFF Integration ON Dynamic Tailoring OFF Message Intensity ON
  • Active Comparator: Arm 7
    • Personalization OFF Integration ON Dynamic Tailoring ON Message Intensity OFF
  • Active Comparator: Arm 8
    • Personalization OFF Integration ON Dynamic Tailoring ON Message Intensity ON
  • Active Comparator: Arm 9
    • Personalization ON Integration OFF Dynamic Tailoring OFF Message Intensity OFF
  • Active Comparator: Arm 10
    • Personalization ON Integration OFF Dynamic Tailoring OFF Message Intensity ON
  • Active Comparator: Arm 11
    • Personalization ON Integration OFF Dynamic Tailoring ON Message Intensity OFF
  • Active Comparator: Arm 12
    • Personalization ON Integration OFF Dynamic Tailoring ON Message Intensity ON
  • Active Comparator: Arm 13
    • Personalization ON Integration ON Dynamic Tailoring OFF Message Intensity OFF
  • Active Comparator: Arm 14
    • Personalization ON Integration ON Dynamic Tailoring OFF Message Intensity ON
  • Active Comparator: Arm 15
    • Personalization ON Integration ON Dynamic Tailoring ON Message Intensity OFF
  • Active Comparator: Arm 16
    • Personalization ON Integration ON Dynamic Tailoring ON Message Intensity ON
  • No Intervention: WEB
    • Phase II arm. Full access to standard BecomeAnEX.org web-based smoking cessation program.
  • Active Comparator: WEB+OA_TXT
    • Phase II arm. Full access to standard BecomeAnEX.org web-based smoking cessation program PLUS optimal-adherence text message program from Phase I.

Clinical Trial Outcome Measures

Primary Measures

  • Phase I – Composite adherence metric
    • Time Frame: 3 months
    • 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.
  • Phase II – 30-day point prevalence abstinence
    • Time Frame: 9 months post randomization
    • Self-reported 30-day point prevalence abstinence at 9 months post randomization

Secondary Measures

  • Phase II – 30day point prevalence abstinence
    • Time Frame: 3 months post randomization
    • Self-reported 30-day point prevalence abstinence at 3 months post randomization
  • Phase II – 30day point prevalence abstinence
    • Time Frame: 15 months post randomization
    • Self-reported 30-day point prevalence abstinence at 15 months post randomization

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Truth Initiative
  • Provider of Information About this Clinical Study
    • Principal Investigator: Amanda L. Graham, PhD, Director, Research Development – Truth Initiative
  • Overall Official(s)
    • Amanda L Graham, PhD, Principal Investigator, Truth Initiative

References

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.

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