Technology-Enhanced Quitline Services to Prevent Smoking Relapse

Smoking Cessation Clinical Trial

— TEQ  

Official title:

Technology-Enhanced Quitline Services to Prevent Smoking Relapse

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00888992
• Other study ID #: 0812-77B
• Secondary ID: 1R01CA138936-01
• Status: Completed
• Phase: N/A
• First received: April 27, 2009
• Last updated: April 2, 2015
• Start date: April 2010
• Est. completion date: March 2014

Study information

• Verified date: April 2015
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1785
• Est. completion date: March 2014
• Est. primary completion date: January 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Alere Wellbeing (formally known as Free & Clear, Inc.)	Seattle	Washington

Sponsors (4)

Lead Sponsor	Collaborator
Indiana University	Alere Wellbeing, Kaiser Foundation Hospitals, Center for Health Research, University of Washington

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Participant smoking status.		6 and 12 month follow-up	No