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| Name | Class |
|---|---|
| Vincere Health | INDUSTRY |
| Maryland State Tobacco Quitline | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Quitline treatment as usual (TAU) | Active Comparator | Quitline services provided by participating state quitlines |
|
| Quitline TAU plus remote CO monitoring | Experimental | Quitline service plus daily CO monitoring via a smartphone app |
|
| Quitline TAU plus incentivized remote CO monitoring | Experimental | Quitline TAU plus remote CO monitoring with small monetary incentives |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quitline Treatment as Usual (TAU) | Combination Product | Quitline TAU is services provided by the state quitline and includes phone coaching, nicotine replacement, supplemental materials (e.g., text messaging, online content). |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
• Pregnant or breast feeding
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| Name | Affiliation | Role |
|---|---|---|
| Kelly Carpenter, PhD | Consumer Wellness Solutions | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Optum Center for Wellbeing Research | Seattle | Washington | 98125 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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). |
| FG001 | 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. |
| FG002 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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). |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Count of Participants | Participants | 60 days |
|
Adverse event data were collected for 8 months, from the start of recruitment through the final outcome survey collection.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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). |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Kristina Mullis | Consumer Wellness Solutions/RVO Health | 765-265-9169 | kmullis@rvohealth.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 19, 2022 | Mar 20, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D014029 | Tobacco Use Disorder |
| D020340 | Tobacco Use Cessation |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D015438 | Health Behavior |
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| Remote Carbon Monoxide (CO) Monitoring | Combination Product | Remote CO monitoring includes a smartphone app and a remote carbon monoxide monitor. The app tracks and prompts daily use of the CO monitor. |
|
| Incentivized Remote CO Monitoring | Combination Product | 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. |
|
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 |
| 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. |
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | 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. |
| OG002 | 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. |
|
|
| Primary | Treatment Engagement | Number of quitline calls each participant engages in, collected via clinical record system. | Posted | Mean | Standard Deviation | Calls completed | 60 days |
|
|
|
| Primary | Self-reported Tobacco Abstinence | 7 day point prevalence abstinence from all combustible tobacco collected via follow-up survey | Posted | Count of Participants | Participants | 60 days |
|
|
|
| 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 | Posted | Count of Participants | Participants | 60 days |
|
|
|
| Secondary | Engagement With CO Monitor | Number of times remote CO monitor is used collected via smartphone app. | Posted | Mean | Standard Deviation | Breath tests completed | 60 days |
|
|
|
| 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. | Posted | Count of Participants | Participants | 60 days |
|
|
|
| 0 |
| 73 |
| 0 |
| 73 |
| 0 |
| 73 |
| EG001 | 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. | 0 | 76 | 0 | 76 | 0 | 76 |
| EG002 | 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. | 0 | 80 | 0 | 80 | 0 | 80 |
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| D001519 | Behavior |