Clinical trial NCT01817842: Study of Mobile Phone Support for the DC Tobacco Quitline
Official title: Comparative Effectiveness of Web-based Mobile Support for the DC Tobacco Quitline
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Cessation
Keywords: mHealth
EMA
Ecological Momentary Assessment
Personal Informatics
Tobacco Quitline
Lead sponsor: Truth Initiative
Sponsor class: OTHER
First posted: 2013-03-26
Enrollment: 803
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Active tobacco smoker of at least 5 cigarettes / day
* Read, speak and write English
* Access to a telephone at either home or work
* Contacts DC Tobacco Quitline and makes an attempt to quit smoking

Exclusion Criteria:

-

Primary outcomes:
measure: Smoking Abstinence
timeFrame: 9-months
Secondary outcomes:
measure: Daily Lapse Status
timeFrame: Month 1
measure: Quitline utilization
timeFrame: Month 1
Other outcomes:
Locations:
city: Washington
country: United States
facility: United Medical Center
state: District of Columbia
Study officials:
affiliation: Truth Initiative
name: Thomas R Kirchner, PhD
role: PRINCIPAL_INVESTIGATOR
References: