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
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
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
NCT ID
NCT05327660
First Posted
April 6, 2022
Last Updated
April 6, 2022
Sponsor
Consumer Wellness Solutions
Collaborators
Vincere Health, Maryland State Tobacco Quitline
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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