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Completed

NCT Number: NCT05327660

CO Monitoring for Tobacco Cessation in Quitlines

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. The investigators 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.

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Key information

Conditions

Tobacco Dependence Behavior Chemically-Induced Disorders Health Behavior Mental Disorders Substance-Related Disorders Tobacco Use Cessation Tobacco Use Disorder

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Optum Center for Wellbeing Research

Seattle, Washington, 98125, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Quitline Treatment as Usual (TAU)

Combination Product

Quitline TAU is services provided by the state quitline and includes phone coaching, nicotine replacement, supplemental materials (e.g., text messaging, online content).

Remote Carbon Monoxide (CO) Monitoring

Combination Product

Remote CO monitoring includes a smartphone app and a remote carbon monoxide monitor. The app tracks and prompts daily use of the CO monitor.

Incentivized Remote CO Monitoring

Combination Product

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.

Primary outcomes

  1. Treatment Satisfaction

    Time frame: 60 days

    Rating of satisfaction with quitline services on a 6-point scale collected via follow-up survey. Five questions were internally developed to determine satisfaction with the quitline services provided where low numbers (1-3) mean dissatisfaction and high numbers (4-6) mean satisfaction. Participants that reported a score of 4 (somewhat satisfied) or more are represented in the data table.

  2. Treatment Engagement

    Time frame: 60 days

    Number of quitline calls each participant engages in, collected via clinical record system.

  3. Self-reported Tobacco Abstinence

    Time frame: 60 days

    7 day point prevalence abstinence from all combustible tobacco collected via follow-up survey

Secondary outcomes

  1. Biochemically Verified Tobacco Abstinence

    Time frame: 60 days

    CO monitor reading 60 days post randomization (must be 7ppm or less to be considered abstinent) collected via smartphone app

  2. Engagement With CO Monitor

    Time frame: 60 days

    Number of times remote CO monitor is used collected via smartphone app.

  3. Satisfaction With CO Monitor

    Time frame: 60 days

    Satisfaction with CO monitor measures on a 6-point scale collected via follow-up survey. Five questions were internally developed to determine satisfaction with the CO monitor device and app where low numbers (1-3) mean dissatisfaction and high numbers (4-6) mean satisfaction. Participants that reported a score of 4 (somewhat satisfied) or more are represented in the data table.

Sponsors and collaborators

Lead sponsor

Consumer Wellness Solutions

Industry

Collaborators

  • Maryland State Tobacco Quitline
  • Vincere Health

Registry information

Official study title

Remote Carbon Monoxide Monitoring and Incentives for Tobacco Cessation in Quitlines

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 14, 2022
Registry last updated
Oct 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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