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

Primary Purpose

Smoking Cessation

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Quitline Service + 10 automated monitoring calls
Quitline service + 20 automated monitoring calls
Sponsored by
Indiana University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Smoking Cessation focused on measuring Smoking, Cessation, Quitline, Counseling

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Alere Wellbeing (formally known as Free & Clear, Inc.)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

Group A

Group B

Group C

Arm Description

Receive the usual care provided in Alere Wellbeing's Quit For Life® program. The program includes 5 telephone counseling calls.

Outcomes

Primary Outcome Measures

Participant smoking status.

Secondary Outcome Measures

Full Information

First Posted
April 27, 2009
Last Updated
April 2, 2015
Sponsor
Indiana University
Collaborators
Consumer Wellness Solutions, Kaiser Foundation Hospitals, Center for Health Research, University of Washington
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1. Study Identification

Unique Protocol Identification Number
NCT00888992
Brief Title
Technology-Enhanced Quitline Services to Prevent Smoking Relapse
Acronym
TEQ
Official Title
Technology-Enhanced Quitline Services to Prevent Smoking Relapse
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Indiana University
Collaborators
Consumer Wellness Solutions, Kaiser Foundation Hospitals, Center for Health Research, University of Washington

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Smoking Cessation
Keywords
Smoking, Cessation, Quitline, Counseling

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1785 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
No Intervention
Arm Description
Receive the usual care provided in Alere Wellbeing's Quit For Life® program. The program includes 5 telephone counseling calls.
Arm Title
Group B
Arm Type
Experimental
Arm Title
Group C
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Quitline Service + 10 automated monitoring calls
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Quitline service + 20 automated monitoring calls
Intervention Description
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.
Primary Outcome Measure Information:
Title
Participant smoking status.
Time Frame
6 and 12 month follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anna M McDaniel, PhD RN FAAN
Organizational Affiliation
Indiana University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Susan Zbikowski, PhD
Organizational Affiliation
Consumer Wellness Solutions
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Katie Witkiewitz, PhD
Organizational Affiliation
University of New Mexico
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jeffery Fellows, PhD
Organizational Affiliation
Kaiser Permanente
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alere Wellbeing (formally known as Free & Clear, Inc.)
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
26124508
Citation
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.
Results Reference
derived

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Technology-Enhanced Quitline Services to Prevent Smoking Relapse

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