Tobacco Dependence
Conditions
Keywords
tobacco cessation, tobacco quitlines, carbon monoxide monitoring, incentives
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. 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.
Interventions
COMBINATION_PRODUCTQuitline 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_PRODUCTRemote 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.
COMBINATION_PRODUCTIncentivized 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.
Sponsors
Vincere Health
Maryland State Tobacco Quitline
Consumer Wellness Solutions
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment Satisfaction | 60 days | 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. |
| Treatment Engagement | 60 days | Number of quitline calls each participant engages in, collected via clinical record system. |
| Self-reported Tobacco Abstinence | 60 days | 7 day point prevalence abstinence from all combustible tobacco collected via follow-up survey |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Biochemically Verified Tobacco Abstinence | 60 days | CO monitor reading 60 days post randomization (must be 7ppm or less to be considered abstinent) collected via smartphone app |
| Engagement With CO Monitor | 60 days | Number of times remote CO monitor is used collected via smartphone app. |
| Satisfaction With CO Monitor | 60 days | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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). | 73 |
| 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. | 76 |
| 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. | 80 |
| Total | 229 |
Baseline characteristics
| Characteristic | Quitline Treatment as Usual (TAU) | Total | Quitline TAU Plus Incentivized Remote CO Monitoring | Quitline TAU Plus Remote CO Monitoring |
|---|---|---|---|---|
| Age, Continuous | 53.3 years STANDARD_DEVIATION 11.8 | 54.5 years STANDARD_DEVIATION 11.5 | 55.5 years STANDARD_DEVIATION 11.1 | 54.5 years STANDARD_DEVIATION 11.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 10 Participants | 5 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 69 Participants | 212 Participants | 71 Participants | 72 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 7 Participants | 4 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 4 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 3 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 30 Participants | 107 Participants | 35 Participants | 42 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 7 Participants | 17 Participants | 7 Participants | 3 Participants |
| Race (NIH/OMB) White | 32 Participants | 98 Participants | 36 Participants | 30 Participants |
| Region of Enrollment United States | 73 participants | 229 participants | 80 participants | 76 participants |
| Sex: Female, Male Female | 46 Participants | 143 Participants | 48 Participants | 49 Participants |
| Sex: Female, Male Male | 27 Participants | 86 Participants | 32 Participants | 27 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 73 | 0 / 76 | 0 / 80 |
| other Total, other adverse events | 0 / 73 | 0 / 76 | 0 / 80 |
| serious Total, serious adverse events | 0 / 73 | 0 / 76 | 0 / 80 |
Outcome results
Primary
Self-reported Tobacco Abstinence
7 day point prevalence abstinence from all combustible tobacco collected via follow-up survey
Time frame: 60 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Quitline Treatment as Usual (TAU) | Self-reported Tobacco Abstinence | 15 Participants |
| Quitline TAU Plus Remote CO Monitoring | Self-reported Tobacco Abstinence | 18 Participants |
| Quitline TAU Plus Incentivized Remote CO Monitoring | Self-reported Tobacco Abstinence | 25 Participants |
Primary
Treatment Engagement
Number of quitline calls each participant engages in, collected via clinical record system.
Time frame: 60 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Quitline Treatment as Usual (TAU) | Treatment Engagement | 2.2 Calls completed | Standard Deviation 1.4 |
| Quitline TAU Plus Remote CO Monitoring | Treatment Engagement | 2.3 Calls completed | Standard Deviation 1.6 |
| Quitline TAU Plus Incentivized Remote CO Monitoring | Treatment Engagement | 2.7 Calls completed | Standard Deviation 1.9 |
Primary
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.
Time frame: 60 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Quitline Treatment as Usual (TAU) | Treatment Satisfaction | 38 Participants |
| Quitline TAU Plus Remote CO Monitoring | Treatment Satisfaction | 44 Participants |
| Quitline TAU Plus Incentivized Remote CO Monitoring | Treatment Satisfaction | 56 Participants |
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
Time frame: 60 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Quitline Treatment as Usual (TAU) | Biochemically Verified Tobacco Abstinence | 6 Participants |
| Quitline TAU Plus Remote CO Monitoring | Biochemically Verified Tobacco Abstinence | 14 Participants |
| Quitline TAU Plus Incentivized Remote CO Monitoring | Biochemically Verified Tobacco Abstinence | 20 Participants |
Secondary
Engagement With CO Monitor
Number of times remote CO monitor is used collected via smartphone app.
Time frame: 60 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Quitline Treatment as Usual (TAU) | Engagement With CO Monitor | 7.7 Breath tests completed | Standard Deviation 7.3 |
| Quitline TAU Plus Remote CO Monitoring | Engagement With CO Monitor | 54.8 Breath tests completed | Standard Deviation 49.6 |
| Quitline TAU Plus Incentivized Remote CO Monitoring | Engagement With CO Monitor | 80.9 Breath tests completed | Standard Deviation 48.5 |
Secondary
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.
Time frame: 60 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Quitline Treatment as Usual (TAU) | Satisfaction With CO Monitor | 30 Participants |
| Quitline TAU Plus Remote CO Monitoring | Satisfaction With CO Monitor | 38 Participants |
| Quitline TAU Plus Incentivized Remote CO Monitoring | Satisfaction With CO Monitor | 51 Participants |