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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Alere Wellbeing
Kaiser Foundation Hospitals, Center for Health Research
University of Washington
Information provided by (Responsible Party):
Indiana University
ClinicalTrials.gov Identifier:
NCT00888992
First received: April 27, 2009
Last updated: June 6, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention
Smoking Cessation
Behavioral: Quitline Service + 10 automated monitoring calls
Behavioral: Quitline service + 20 automated monitoring calls

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Technology-Enhanced Quitline Services to Prevent Smoking Relapse

Resource links provided by NLM:


Further study details as provided by Indiana University:

Primary Outcome Measures:
  • Participant smoking status. [ Time Frame: 6 and 12 month follow-up ] [ Designated as safety issue: No ]

Estimated Enrollment: 1785
Study Start Date: April 2010
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Group A
Receive the usual care provided in Alere Wellbeing's Quit For Life® program. The program includes 5 telephone counseling calls.
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00888992

Locations
United States, Washington
Alere Wellbeing (formally known as Free & Clear, Inc.)
Seattle, Washington, United States, 98104
Sponsors and Collaborators
Indiana University
Alere Wellbeing
Kaiser Foundation Hospitals, Center for Health Research
University of Washington
Investigators
Principal Investigator: Anna M McDaniel, PhD RN FAAN Indiana University
Principal Investigator: Susan Zbikowski, PhD Alere Wellbeing
Principal Investigator: Katie Witkiewitz, PhD University of New Mexico
Principal Investigator: Jeffery Fellows, PhD Kaiser Permanente
  More Information

No publications provided

Responsible Party: Indiana University
ClinicalTrials.gov Identifier: NCT00888992     History of Changes
Other Study ID Numbers: 0812-77B, 1R01CA138936-01
Study First Received: April 27, 2009
Last Updated: June 6, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Indiana University:
Smoking
Cessation
Quitline
Counseling

ClinicalTrials.gov processed this record on August 19, 2014