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CO Monitoring for Tobacco Cessation in Quitlines

Primary Purpose

Tobacco Dependence

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Quitline Treatment as Usual (TAU)
Remote Carbon Monoxide (CO) Monitoring
Incentivized Remote CO Monitoring
Sponsored by
Consumer Wellness Solutions
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tobacco Dependence focused on measuring tobacco cessation, tobacco quitlines, carbon monoxide monitoring, incentives

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Optum Center for Wellbeing ResearchRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Quitline treatment as usual (TAU)

Quitline TAU plus remote CO monitoring

Quitline TAU plus incentivized remote CO monitoring

Arm Description

Quitline services provided by participating state quitlines

Quitline service plus daily CO monitoring via a smartphone app

Quitline TAU plus remote CO monitoring with small monetary incentives

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
April 6, 2022
Last Updated
April 6, 2022
Sponsor
Consumer Wellness Solutions
Collaborators
Vincere Health, Maryland State Tobacco Quitline
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1. Study Identification

Unique Protocol Identification Number
NCT05327660
Brief Title
CO Monitoring for Tobacco Cessation in Quitlines
Official Title
Remote Carbon Monoxide Monitoring and Incentives for Tobacco Cessation in Quitlines
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 31, 2021 (Actual)
Primary Completion Date
November 1, 2022 (Anticipated)
Study Completion Date
November 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Consumer Wellness Solutions
Collaborators
Vincere Health, Maryland State Tobacco Quitline

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tobacco Dependence
Keywords
tobacco cessation, tobacco quitlines, carbon monoxide monitoring, incentives

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Quitline treatment as usual (TAU)
Arm Type
Active Comparator
Arm Description
Quitline services provided by participating state quitlines
Arm Title
Quitline TAU plus remote CO monitoring
Arm Type
Experimental
Arm Description
Quitline service plus daily CO monitoring via a smartphone app
Arm Title
Quitline TAU plus incentivized remote CO monitoring
Arm Type
Experimental
Arm Description
Quitline TAU plus remote CO monitoring with small monetary incentives
Intervention Type
Combination Product
Intervention Name(s)
Quitline Treatment as Usual (TAU)
Intervention Description
Quitline TAU is services provided by the state quitline and includes phone coaching, nicotine replacement, supplemental materials (e.g., text messaging, online content).
Intervention Type
Combination Product
Intervention Name(s)
Remote Carbon Monoxide (CO) Monitoring
Intervention Description
Remote CO monitoring includes a smartphone app and a remote carbon monoxide monitor. The app tracks and prompts daily use of the CO monitor.
Intervention Type
Combination Product
Intervention Name(s)
Incentivized Remote CO Monitoring
Intervention Description
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 Outcome Measure Information:
Title
Treatment satisfaction
Description
Rating of satisfaction with quitline services on a 6 point scale collected via follow-up survey
Time Frame
60 days
Title
Treatment engagement
Description
Number of quitline calls each participant engages in, collected via clinical record system.
Time Frame
60 days
Title
Self-reported tobacco abstinence
Description
7 day point prevalence abstinence from all combustible tobacco collected via follow-up survey
Time Frame
60 days
Secondary Outcome Measure Information:
Title
Biochemically verified tobacco abstinence
Description
CO monitor reading 60 days post randomization (must be 7ppm or less to be considered abstinent) collected via smartphone app
Time Frame
60 days
Title
Engagement with CO monitor
Description
Number of times remote CO monitor is used collected via smartphone app.
Time Frame
60 days
Title
Satisfaction with CO monitor
Description
Satisfaction with CO monitor measures on 6-point scale collected via follow-up survey
Time Frame
60 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Caryn Chalmers, MPH
Phone
763-330-8300
Email
caryn.chalmers@optum.com
First Name & Middle Initial & Last Name or Official Title & Degree
Kelly Carpenter, PhD
Email
kelly.carpenter@optum.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kelly Carpenter, PhD
Organizational Affiliation
Consumer Wellness Solutions
Official's Role
Principal Investigator
Facility Information:
Facility Name
Optum Center for Wellbeing Research
City
Seattle
State/Province
Washington
ZIP/Postal Code
98125
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Caryn Chalmers, MPH
Phone
763-330-8300
Email
caryn.chalmers@optum.com

12. IPD Sharing Statement

Plan to Share IPD
No

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CO Monitoring for Tobacco Cessation in Quitlines

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