Technology-Enhanced Quitline Services to Prevent Smoking Relapse

Study Overview
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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.

Official Title
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Technology-Enhanced Quitline Services to Prevent Smoking Relapse

Conditions
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Smoking Cessation

Intervention / Treatment
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* Behavioral: Quitline Service + 10 automated monitoring calls
* Behavioral: Quitline service + 20 automated monitoring calls


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Group A<br>Receive the usual care provided in Alere Wellbeing's Quit For Life® program. The program includes 5 telephone counseling calls. | |
| Experimental: Group B<br> | Behavioral: Quitline Service + 10 automated monitoring calls<br>* 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.<br>|
| Experimental: Group C<br> | Behavioral: Quitline service + 20 automated monitoring calls<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participant smoking status. |  | 6 and 12 month follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Smoking, Cessation, Quitline, Counseling