Technology-Enhanced Quitline Services to Prevent Smoking Relapse

NCT ID: NCT00888992

Last Updated: 2015-04-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1785 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2014-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Smoking Cessation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Group A

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Group B

Group Type EXPERIMENTAL

Quitline Service + 10 automated monitoring calls

Intervention Type BEHAVIORAL

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.

Group C

Group Type EXPERIMENTAL

Quitline service + 20 automated monitoring calls

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Consumer Wellness Solutions

INDUSTRY

Sponsor Role collaborator

Kaiser Foundation Hospitals, Center for Health Research

OTHER

Sponsor Role collaborator

University of Washington

OTHER

Sponsor Role collaborator

Indiana University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anna M McDaniel, PhD RN FAAN

Role: PRINCIPAL_INVESTIGATOR

Indiana University

Susan Zbikowski, PhD

Role: PRINCIPAL_INVESTIGATOR

Consumer Wellness Solutions

Katie Witkiewitz, PhD

Role: PRINCIPAL_INVESTIGATOR

University of New Mexico

Jeffery Fellows, PhD

Role: PRINCIPAL_INVESTIGATOR

Kaiser Permanente

Locations

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

Seattle, Washington, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 26124508 (View on PubMed)

Other Identifiers

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1R01CA138936-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

0812-77B

Identifier Type: -

Identifier Source: org_study_id

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