CO Monitoring for Tobacco Cessation in Quitlines

Remote Carbon Monoxide Monitoring and Incentives 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.

Study Overview

• Status: Completed
• Conditions: Tobacco Dependence
• Intervention / Treatment: Combination product: Quitline Treatment as Usual (TAU); Combination product: Remote Carbon Monoxide (CO) Monitoring; Combination product: Incentivized Remote CO Monitoring

• Study Type: Interventional
• Enrollment (Actual): 229
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98125
      • Optum Center for Wellbeing Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Quitline treatment as usual (TAU); Quitline services provided by participating state quitlines	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).
Experimental: Quitline TAU plus remote CO monitoring; Quitline service plus daily CO monitoring via a smartphone app	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).; Combination product: 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.
Experimental: Quitline TAU plus incentivized remote CO monitoring; Quitline TAU plus remote CO monitoring with small monetary incentives	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).; Combination product: 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.

What is the study measuring?

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. 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.	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 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.	60 days

Collaborators and Investigators

• Sponsor: Consumer Wellness Solutions
• Collaborators: Vincere Health; Maryland State Tobacco Quitline
• Investigators: Principal Investigator: Kelly Carpenter, PhD, Consumer Wellness Solutions

Study record dates

Study Major Dates

• Study Start (Actual): December 31, 2021
• Primary Completion (Actual): November 1, 2022
• Study Completion (Actual): November 1, 2022

Study Registration Dates

• First Submitted: April 6, 2022
• First Submitted That Met QC Criteria: April 6, 2022
• First Posted (Actual): April 14, 2022

Study Record Updates

• Last Update Posted (Actual): October 28, 2024
• Last Update Submitted That Met QC Criteria: October 24, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: tobacco cessation; incentives; tobacco quitlines; carbon monoxide monitoring
• Additional Relevant MeSH Terms: Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Tobacco Use Disorder; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antimetabolites; Neurotransmitter Agents; Gasotransmitters; Carbon Monoxide
• Other Study ID Numbers: 2021-0056

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No