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

T

Truth Initiative

Status

Completed

Conditions

Smoking Cessation

Treatments

Behavioral: Personalization
Behavioral: Dynamic Tailoring
Behavioral: Integration
Behavioral: Message Intensity
Behavioral: Optimal-Adherence Text

Study type

Interventional

Funder types

Other

Identifiers

NCT02585206
1R01DA038139

Details and patient eligibility

About

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.

Full 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.

Enrollment

1,485 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

Single Blind

1,485 participants in 18 patient groups

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

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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