NCT00888992

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,785

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 27, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 28, 2009

Completed
11 months until next milestone

Study Start

First participant enrolled

April 1, 2010

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

April 3, 2015

Status Verified

April 1, 2015

Enrollment Period

2.8 years

First QC Date

April 27, 2009

Last Update Submit

April 2, 2015

Conditions

Smoking Cessation

Keywords

SmokingCessationQuitlineCounseling

Outcome Measures

Primary Outcomes (1)

  • Participant smoking status.

    6 and 12 month follow-up

Study Arms (3)

Group A

NO INTERVENTION

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

Group B

EXPERIMENTAL
Behavioral: Quitline Service + 10 automated monitoring calls

Group C

EXPERIMENTAL
Behavioral: Quitline service + 20 automated monitoring calls

Interventions

Quitline Service + 10 automated monitoring callsBEHAVIORAL

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 B
Quitline service + 20 automated monitoring callsBEHAVIORAL

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.

Group C

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Seattle, Washington, 98104, United States

Location

Related Publications (1)

  • 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.

    PMID: 26124508DERIVED

MeSH Terms

Conditions

Smoking CessationSmoking

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Study Officials

  • Anna M McDaniel, PhD RN FAAN

    Indiana University

    PRINCIPAL INVESTIGATOR

  • Susan Zbikowski, PhD

    Consumer Wellness Solutions

    PRINCIPAL INVESTIGATOR

  • Katie Witkiewitz, PhD

    University of New Mexico

    PRINCIPAL INVESTIGATOR

  • Jeffery Fellows, PhD

    Kaiser Permanente

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 27, 2009

First Posted

April 28, 2009

Study Start

April 1, 2010

Primary Completion

January 1, 2013

Study Completion

March 1, 2014

Last Updated

April 3, 2015

Record last verified: 2015-04

Locations

US(1)