Trial Outcomes & Findings for CO Monitoring for Tobacco Cessation in Quitlines (NCT NCT05327660)
NCT ID: NCT05327660
Last Updated: 2024-10-28
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
229 participants
Primary outcome timeframe
60 days
Results posted on
2024-10-28
Participant Flow
Participant milestones
| Measure |
Quitline Treatment as Usual (TAU)
Quitline services provided by participating state quitlines
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).
|
Quitline TAU Plus Remote CO Monitoring
Quitline service plus daily CO monitoring via a smartphone app
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.
|
Quitline TAU Plus Incentivized Remote CO Monitoring
Quitline TAU plus remote CO monitoring with small monetary incentives
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).
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
73
|
76
|
80
|
|
Overall Study
COMPLETED
|
73
|
76
|
80
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
CO Monitoring for Tobacco Cessation in Quitlines
Baseline characteristics by cohort
| Measure |
Quitline Treatment as Usual (TAU)
n=73 Participants
Quitline services provided by participating state quitlines
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).
|
Quitline TAU Plus Remote CO Monitoring
n=76 Participants
Quitline service plus daily CO monitoring via a smartphone app
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.
|
Quitline TAU Plus Incentivized Remote CO Monitoring
n=80 Participants
Quitline TAU plus remote CO monitoring with small monetary incentives
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).
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.
|
Total
n=229 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
53.3 years
STANDARD_DEVIATION 11.8 • n=5 Participants
|
54.5 years
STANDARD_DEVIATION 11.7 • n=7 Participants
|
55.5 years
STANDARD_DEVIATION 11.1 • n=5 Participants
|
54.5 years
STANDARD_DEVIATION 11.5 • n=4 Participants
|
|
Sex: Female, Male
Female
|
46 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
143 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
86 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
69 Participants
n=5 Participants
|
72 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
212 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
30 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
107 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
32 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
98 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
73 participants
n=5 Participants
|
76 participants
n=7 Participants
|
80 participants
n=5 Participants
|
229 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 60 daysRating 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.
Outcome measures
| Measure |
Quitline Treatment as Usual (TAU)
n=41 Participants
Quitline services provided by participating state quitlines
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).
|
Quitline TAU Plus Remote CO Monitoring
n=47 Participants
Quitline service plus daily CO monitoring via a smartphone app
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.
|
Quitline TAU Plus Incentivized Remote CO Monitoring
n=59 Participants
Quitline TAU plus remote CO monitoring with small monetary incentives
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).
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.
|
|---|---|---|---|
|
Treatment Satisfaction
|
38 Participants
|
44 Participants
|
56 Participants
|
PRIMARY outcome
Timeframe: 60 daysNumber of quitline calls each participant engages in, collected via clinical record system.
Outcome measures
| Measure |
Quitline Treatment as Usual (TAU)
n=73 Participants
Quitline services provided by participating state quitlines
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).
|
Quitline TAU Plus Remote CO Monitoring
n=76 Participants
Quitline service plus daily CO monitoring via a smartphone app
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.
|
Quitline TAU Plus Incentivized Remote CO Monitoring
n=80 Participants
Quitline TAU plus remote CO monitoring with small monetary incentives
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).
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.
|
|---|---|---|---|
|
Treatment Engagement
|
2.2 Calls completed
Standard Deviation 1.4
|
2.3 Calls completed
Standard Deviation 1.6
|
2.7 Calls completed
Standard Deviation 1.9
|
PRIMARY outcome
Timeframe: 60 days7 day point prevalence abstinence from all combustible tobacco collected via follow-up survey
Outcome measures
| Measure |
Quitline Treatment as Usual (TAU)
n=73 Participants
Quitline services provided by participating state quitlines
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).
|
Quitline TAU Plus Remote CO Monitoring
n=76 Participants
Quitline service plus daily CO monitoring via a smartphone app
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.
|
Quitline TAU Plus Incentivized Remote CO Monitoring
n=80 Participants
Quitline TAU plus remote CO monitoring with small monetary incentives
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).
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.
|
|---|---|---|---|
|
Self-reported Tobacco Abstinence
|
15 Participants
|
18 Participants
|
25 Participants
|
SECONDARY outcome
Timeframe: 60 daysCO monitor reading 60 days post randomization (must be 7ppm or less to be considered abstinent) collected via smartphone app
Outcome measures
| Measure |
Quitline Treatment as Usual (TAU)
n=73 Participants
Quitline services provided by participating state quitlines
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).
|
Quitline TAU Plus Remote CO Monitoring
n=76 Participants
Quitline service plus daily CO monitoring via a smartphone app
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.
|
Quitline TAU Plus Incentivized Remote CO Monitoring
n=80 Participants
Quitline TAU plus remote CO monitoring with small monetary incentives
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).
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.
|
|---|---|---|---|
|
Biochemically Verified Tobacco Abstinence
|
6 Participants
|
14 Participants
|
20 Participants
|
SECONDARY outcome
Timeframe: 60 daysNumber of times remote CO monitor is used collected via smartphone app.
Outcome measures
| Measure |
Quitline Treatment as Usual (TAU)
n=26 Participants
Quitline services provided by participating state quitlines
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).
|
Quitline TAU Plus Remote CO Monitoring
n=55 Participants
Quitline service plus daily CO monitoring via a smartphone app
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.
|
Quitline TAU Plus Incentivized Remote CO Monitoring
n=56 Participants
Quitline TAU plus remote CO monitoring with small monetary incentives
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).
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.
|
|---|---|---|---|
|
Engagement With CO Monitor
|
7.7 Breath tests completed
Standard Deviation 7.3
|
54.8 Breath tests completed
Standard Deviation 49.6
|
80.9 Breath tests completed
Standard Deviation 48.5
|
SECONDARY outcome
Timeframe: 60 daysSatisfaction 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.
Outcome measures
| Measure |
Quitline Treatment as Usual (TAU)
n=34 Participants
Quitline services provided by participating state quitlines
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).
|
Quitline TAU Plus Remote CO Monitoring
n=42 Participants
Quitline service plus daily CO monitoring via a smartphone app
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.
|
Quitline TAU Plus Incentivized Remote CO Monitoring
n=55 Participants
Quitline TAU plus remote CO monitoring with small monetary incentives
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).
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.
|
|---|---|---|---|
|
Satisfaction With CO Monitor
|
30 Participants
|
38 Participants
|
51 Participants
|
Adverse Events
Quitline Treatment as Usual (TAU)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Quitline TAU Plus Remote CO Monitoring
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Quitline TAU Plus Incentivized Remote CO Monitoring
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Kristina Mullis
Consumer Wellness Solutions/RVO Health
Phone: 765-265-9169
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place