Smoking Cessation Clinical Trial
Official title:
Comparative Effectiveness of Web-based Mobile Support for the DC Tobacco Quitline
This is a study of the effectiveness of mobile phone support for the D.C. Tobacco Quitline. The project will test the efficacy of a web-based system that uses mobile phones to improve quit rates at 3-month intervals, relative to standard quitline services. Under the standard model, relatively infrequent, periodic support is provided to smokers who want to quit and seek out the services. The new system will complement that effort by increasing the quality, frequency and accessibility of quit smoking support - when and where the smoker needs it most. It is hypothesized that successful abstinence rates will improve to the degree that participants utilize the support system and engage with the quitline.
This study aims to bolster the effectiveness of the Washington D.C. Quitline (DCQL) program
with the addition of a web-based mobile EX (mEX) cessation support system. This mEX system
is designed to fill the gaps between quitline calls with ready access to a menu of
evidenced-based treatment components, while also providing DCQL counselors with detailed
information about their clients' ongoing progress with cessation - two developments that
constitute a major advance over standard quitline programming. With the addition of mEX,
DCQL counselors will be able to tailor their advice from the outset of each call and even
identify counterproductive patterns that would have otherwise gone unnoticed. This
innovative extension of our previous work leverages our expertise with ecological assessment
methodology and behavioral informatics for the purpose of dynamic relapse prevention support
within the context of an underserved community QL.
The project is an additive two-group randomized controlled trial to test whether the
addition of mEX improves abstinence rates at 1-, 3-, 6-, and 9-months relative to standard
care provided by DCQL. Participants will be 700 smokers who contact the DCQL and are
randomized to receive either standard DCQL programming (N=300) or DCQL plus MQE (N=400).
Participants assigned to standard DCQL programming will receive 6 proactive QL counseling
sessions and free nicotine replacement therapy (NRT). Participants assigned to DCQL plus MQE
will also receive mobile access to the MQE system via a web-enabled cellular telephone
provided by the study. Relative to usual care, we expect that MQE will improve outcomes by
improving delivery, utilization and thereby effectiveness of DCQL resources.
Specific Aim 1. Examine abstinence rates in DCQL participants receiving usual-care relative
to those also receiving mobile quitline enhancement. Relative to usual-care controls, mobile
quitline enhancement is expected to improve 7-day point prevalence abstinence rates at 1-,
3-, 6-, and 9-months.
Specific Aim 2. Examine treatment utilization in DCQL participants receiving usual-care
relative to those also receiving mobile quitline enhancement. Relative to usual-care
controls, mobile quitline enhancement is expected to improve utilization of available DCQL
programming resources.
Specific Aim 3. Examine whether utilization of DCQL or mobile support services moderates
their impact on outcomes. Treatment effects are expected to vary with the degree that they
are utilized, such that greater utilization will predict improved abstinence rates at all
time points.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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