Study of Mobile Phone Support for the DC Tobacco Quitline

Smoking Cessation Clinical Trial

Official title:

Comparative Effectiveness of Web-based Mobile Support for the DC Tobacco Quitline

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01817842
• Other study ID #: RC1DA028710
• Status: Completed
• Phase: N/A
• First received: March 20, 2013
• Last updated: March 21, 2013
• Start date: July 2010
• Est. completion date: February 2012

Study information

• Verified date: March 2013
• Source: Truth Initiative
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 803
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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:

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

Behavioral:
• Mobile EX cessation support
Mobile EX cessation support is designed to enhance the Washington D.C. Quitline (DCQL) by giving participants the ability track their cessation attempt on a phone-based app and thus create a profile documenting their progress and set-backs over the days or weeks in between QL contacts. Participants receive summary information and graphics that help them understand what is working best for them. Participants also receive 24-hr, momentary access to a set of interactive cessation tools on their phone.
• DC Quitline Support
Participants assigned to standard DC Quitline programming receive 6 proactive QL counseling sessions and optional, free nicotine replacement therapy (NRT).
• Device Control
Mobile phone for use during cessation attempt but with no mEX support components

Locations

Country	Name	City	State
United States	United Medical Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Truth Initiative

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Smoking Abstinence	Point-prevalent abstinence from smoking cigarettes over the past 7-days. Verified with expired carbon monoxide at 1-month. Reported by participants at 3-, 6- and 9-months.	9-months	No
Secondary	Daily Lapse Status	Daily abstinence versus any smoking (i.e., lapse) status among those who are actively trying to abstain (i.e., not those who have completely relapsed).	Month 1	No
Secondary	Quitline utilization	Participant receipt and initiation of support calls from DC Quitline staff.	Month 1	No