CO Monitoring for Tobacco Cessation in Quitlines

Study Overview
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Brief Summary
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The present study is a 3-arm randomized controlled pilot study. Participants who call the Maryland Tobacco Quitline and are eligible for study participation are randomized to receive quitline tobacco cessation treatment as usual (TAU), TAU plus remote carbon monoxide (CO) monitoring via smartphone app, or TAU plus remote carbon monoxide monitoring plus incentives vis smartphone app. We hypothesize that remote CO monitoring will be feasible and acceptable to deliver in the quitline setting, will increase treatment engagement, and will increase tobacco cessation and treatment satisfaction rates.

Official Title
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Remote Carbon Monoxide Monitoring and Incentives for Tobacco Cessation in Quitlines

Conditions
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Tobacco Dependence

Intervention / Treatment
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* Combination Product: Quitline Treatment as Usual (TAU)
* Combination Product: Remote Carbon Monoxide (CO) Monitoring
* Combination Product: Incentivized Remote CO Monitoring


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Daily cigarette smokers calling into participating quitlines 18 year or older Reads and speaks English Has a smartphone with a data plan Willing to download and use study app Willing to use CO monitor Exclusion Criteria: • Pregnant or breast feeding

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Quitline treatment as usual (TAU)<br>Quitline services provided by participating state quitlines | Combination Product: Quitline Treatment as Usual (TAU)<br>* Quitline TAU is services provided by the state quitline and includes phone coaching, nicotine replacement, supplemental materials (e.g., text messaging, online content).<br>|
| Experimental: Quitline TAU plus remote CO monitoring<br>Quitline service plus daily CO monitoring via a smartphone app | Combination Product: Quitline Treatment as Usual (TAU)<br>* Quitline TAU is services provided by the state quitline and includes phone coaching, nicotine replacement, supplemental materials (e.g., text messaging, online content).<br>Combination Product: Remote Carbon Monoxide (CO) Monitoring<br>* Remote CO monitoring includes a smartphone app and a remote carbon monoxide monitor. The app tracks and prompts daily use of the CO monitor.<br>|
| Experimental: Quitline TAU plus incentivized remote CO monitoring<br>Quitline TAU plus remote CO monitoring with small monetary incentives | Combination Product: Quitline Treatment as Usual (TAU)<br>* Quitline TAU is services provided by the state quitline and includes phone coaching, nicotine replacement, supplemental materials (e.g., text messaging, online content).<br>Combination Product: Incentivized Remote CO Monitoring<br>* Incentivized remote CO monitoring includes a smartphone app and a remote carbon monoxide monitor. The app tracks and prompts daily use of the CO monitor and delivers small monetary incentives for each use of the CO monitor.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment satisfaction | Rating of satisfaction with quitline services on a 6 point scale collected via follow-up survey | 60 days | 
| Treatment engagement | Number of quitline calls each participant engages in, collected via clinical record system. | 60 days | 
| Self-reported tobacco abstinence | 7 day point prevalence abstinence from all combustible tobacco collected via follow-up survey | 60 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biochemically verified tobacco abstinence | CO monitor reading 60 days post randomization (must be 7ppm or less to be considered abstinent) collected via smartphone app | 60 days | 
| Engagement with CO monitor | Number of times remote CO monitor is used collected via smartphone app. | 60 days | 
| Satisfaction with CO monitor | Satisfaction with CO monitor measures on 6-point scale collected via follow-up survey | 60 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tobacco cessation, tobacco quitlines, carbon monoxide monitoring, incentives