Technology-Enhanced Quitline Services to Prevent Smoking Relapse (TEQ)

The purpose of this study is to see if automated telephone monitoring will enhance existing quitline services, such as Alere Wellbeing's Quit For Life program, and help people quit smoking. If successful, this intervention could be incorporated into existing quitline protocols and delivered to millions of people who are trying to quit smoking.

Study Overview

• Status: Completed
• Conditions: Smoking Cessation
• Intervention / Treatment: Behavioral: Quitline Service + 10 automated monitoring calls; Behavioral: Quitline service + 20 automated monitoring calls

• Study Type: Interventional
• Enrollment (Actual): 1785
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98104
      • Alere Wellbeing (formally known as Free & Clear, Inc.)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 18 years or older
• Enrolled in Free & Clear, Inc. services
• Self-reported abstinence for at least 24 hours at the quit date call
• Able to read and speak English
• Personal access to a touch-tone telephone or cellular telephone

Exclusion Criteria:

• Have not stopped smoking for 24 hours
• Currently incarcerated
• Currently participating in any other smoking cessation research
• Live in same household as another study participant
• Participated in the Alere Wellbeing Quit for Life Program within the last 6 months
• Were previously enrolled in this study even if they repeat the smoking cessation program during the accrual period
• Hearing impaired enrollees receiving Free & Clear services via telecommunications devices for the deaf (TDD) will be excluded from the study as the IVR technology currently does not have this capability

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group B	Behavioral: Quitline Service + 10 automated monitoring calls; This group will receive the usual care provided in Alere Wellbeing's Quit For Life® program. The program includes 5 telephone counseling calls. In addition, participants receive 10 automated telephone monitoring calls to help them stay off cigarettes. The automated call schedule will be two calls per a week for 2 weeks, then once a week for 6 weeks. Participants whose answers indicate that they may be having trouble quitting smoking will be automatically connected to a Quit Coach for individualized relapse prevention counseling.
Experimental: Group C	Behavioral: Quitline service + 20 automated monitoring calls; This group will receive the usual care provided in Alere Wellbeing's Quit For Life® program. The program includes 5 telephone counseling calls. In addition, participants receive 20 automated telephone monitoring calls to help them stay off cigarettes. The automated call schedule will be one automated call a day for 2 weeks, then once a week for 6 weeks. Participants whose answers indicate that they may be having trouble quitting smoking will be automatically connected to a Quit Coach for individualized relapse prevention counseling.
No Intervention: Group A; Receive the usual care provided in Alere Wellbeing's Quit For Life® program. The program includes 5 telephone counseling calls.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Participant smoking status.	6 and 12 month follow-up

Collaborators and Investigators

• Sponsor: Indiana University
• Collaborators: University of Washington; Consumer Wellness Solutions; Kaiser Foundation Hospitals, Center for Health Research
• Investigators: Principal Investigator: Katie Witkiewitz, PhD, University of New Mexico; Principal Investigator: Anna M McDaniel, PhD RN FAAN, Indiana University; Principal Investigator: Susan Zbikowski, PhD, Consumer Wellness Solutions; Principal Investigator: Jeffery Fellows, PhD, Kaiser Permanente

Publications and helpful links

General Publications

• McDaniel AM, Vickerman KA, Stump TE, Monahan PO, Fellows JL, Weaver MT, Carlini BH, Champion VL, Zbikowski SM. A randomised controlled trial to prevent smoking relapse among recently quit smokers enrolled in employer and health plan sponsored quitlines. BMJ Open. 2015 Jun 29;5(6):e007260. doi: 10.1136/bmjopen-2014-007260.

Study record dates

Study Major Dates

• Study Start: April 1, 2010
• Primary Completion (Actual): January 1, 2013
• Study Completion (Actual): March 1, 2014

Study Registration Dates

• First Submitted: April 27, 2009
• First Submitted That Met QC Criteria: April 27, 2009
• First Posted (Estimate): April 28, 2009

Study Record Updates

• Last Update Posted (Estimate): April 3, 2015
• Last Update Submitted That Met QC Criteria: April 2, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Keywords: Counseling; Smoking; Quitline; Cessation
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Recurrence
• Other Study ID Numbers: 0812-77B; 1R01CA138936-01 (U.S. NIH Grant/Contract)