CO Monitoring for Tobacco Cessation in Quitlines

Tobacco Dependence Clinical Trial

Official title:

Remote Carbon Monoxide Monitoring and Incentives for Tobacco Cessation in Quitlines

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05327660
• Other study ID #: 2021-0056
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: December 31, 2021
• Est. completion date: November 1, 2022

Study information

• Verified date: April 2022
• Source: Consumer Wellness Solutions
• Contact: Caryn Chalmers, MPH
• Phone: 763-330-8300
• Email: caryn.chalmers[@]optum.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: November 1, 2022
• Est. primary completion date: November 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Tobacco Dependence
• Tobacco Use Disorder

Intervention

Combination Product:
• Quitline Treatment as Usual (TAU)
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
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
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.

Locations

Country	Name	City	State
United States	Optum Center for Wellbeing Research	Seattle	Washington

Sponsors (3)

Lead Sponsor	Collaborator
Consumer Wellness Solutions	Maryland State Tobacco Quitline, Vincere Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment satisfaction	Rating of satisfaction with quitline services on a 6 point scale collected via follow-up survey	60 days
Primary	Treatment engagement	Number of quitline calls each participant engages in, collected via clinical record system.	60 days
Primary	Self-reported tobacco abstinence	7 day point prevalence abstinence from all combustible tobacco collected via follow-up survey	60 days
Secondary	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
Secondary	Engagement with CO monitor	Number of times remote CO monitor is used collected via smartphone app.	60 days
Secondary	Satisfaction with CO monitor	Satisfaction with CO monitor measures on 6-point scale collected via follow-up survey	60 days