NCT01817842

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
803

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2010

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

March 20, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 26, 2013

Completed
Last Updated

March 26, 2013

Status Verified

March 1, 2013

Enrollment Period

1.6 years

First QC Date

March 20, 2013

Last Update Submit

March 21, 2013

Conditions

Smoking Cessation

Keywords

mHealthEMAEcological Momentary AssessmentPersonal InformaticsTobacco Quitline

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • Daily Lapse Status

    Month 1

  • Quitline utilization

    Month 1

Study Arms (2)

mEX support

EXPERIMENTAL

Participants in this arm receive both standard DC Quitline Support and 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.

Behavioral: Mobile EX cessation supportBehavioral: DC Quitline Support

Device Control

ACTIVE COMPARATOR

Participants randomized to this arm receive standard DC Quitline Support plus the device control. Device control includes an identical device (i.e., mobile phone) to that provided to the intervention group, but participants do not receive any of the phone-based mEX support features. Those in the device control group receive their device at the 1-month time point - a design feature that allows a direct comparison of the mEX intervention to standard quitline services over the first month.

Behavioral: DC Quitline SupportBehavioral: Device Control

Interventions

Mobile EX cessation supportBEHAVIORAL

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.

Also known as: mEX
mEX support
DC Quitline SupportBEHAVIORAL

Participants assigned to standard DC Quitline programming receive 6 proactive QL counseling sessions and optional, free nicotine replacement therapy (NRT).

Device ControlmEX support
Device ControlBEHAVIORAL

Mobile phone for use during cessation attempt but with no mEX support components

Device Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

United Medical Center

Washington D.C., District of Columbia, 20036, United States

Location

MeSH Terms

Conditions

Smoking Cessation

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Study Officials

  • Thomas R Kirchner, PhD

    Truth Initiative

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Investigator

Study Record Dates

First Submitted

March 20, 2013

First Posted

March 26, 2013

Study Start

July 1, 2010

Primary Completion

February 1, 2012

Study Completion

February 1, 2012

Last Updated

March 26, 2013

Record last verified: 2013-03

Locations

US(1)