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| Name | Class |
|---|---|
| Maryland Department of Health and Mental Hygiene | OTHER_GOV |
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The objective of this study is to conduct a randomized controlled trial to determine whether the use of the COach2Quit application (app) reduces smoking more than brief advice for smoking cessation. The investigators hypothesize that real time biomarker feedback and messaging support from the COach2Quit app will lead to greater smoking cessation rates than brief anti-smoking advice alone. If effective, the COach2Quit app could be an easily accessible and cost-effective tool to help smokers quit. The findings from this trial could have implications for the delivery of future outpatient smoking cessation programs.
The goal of this randomized controlled trial is to assess the efficacy of the novel COach2Quit smartphone application by determining whether the use of this app reduces smoking more than brief anti-smoking advice alone. This will be a two-arm individually randomized trial and participants who are currently smoking will be assigned 1:1 to either study arm. Smoking behavior will be measured through self-report at baseline, 2-week and 1-month follow up visits. Smoking behavior will also be verified by 2 biomarker measurements: carbon monoxide breath test and urine cotinine, collected at baseline, 2-week and 1-month follow-up visits. In addition, participants will receive weekly follow-up calls. The primary outcome will be smoking cessation at the 1-month follow-up visit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Active Comparator | A certified smoking cessation interventionist (SCI) will deliver standardized smoking cessation counseling using the National Cancer Institute (NCI) 5 A's model. |
|
| COach2Quit | Experimental | A certified smoking cessation interventionist (SCI) will deliver standardized smoking cessation counseling using the National Cancer Institute's 5 A's model. Participants in the COach2Quit arm will be provided with an individualized carbon monoxide (iCO) monitor along with instructions on the use of the monitor and the COach2Quit application. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Individualized carbon monoxide (iCO) monitor | Device | a personal monitor for a breath test for carbon monoxide (CO) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Smoking Status Using a Point of Care Test for Measuring Carbon Monoxide (CO) | A point of care test for measuring carbon monoxide (CO) will be conducted via the piCO Smokerlyzer from OPS Medical, designed specifically for smoking cessation programs and tobacco control programs. Carbon monoxide will be measured in an exhaled breath in parts-per-million (ppm). A reading of ≤ 10ppm will indicate abstinence. | baseline |
| Smoking Status Using a Point of Care Test for Measuring Carbon Monoxide (CO) | A point of care test for measuring carbon monoxide (CO) will be conducted via the piCO Smokerlyzer from OPS Medical, designed specifically for smoking cessation programs and tobacco control programs. Carbon monoxide will be measured in an exhaled breath in parts-per-million (ppm). A reading of ≤ 10ppm will indicate abstinence. | 1 month |
| Number of Participants With Color Change for Urine Test for Measuring Cotinine | A point of care urine test for measuring cotinine will also be conducted via the SmokeScreen® test from GFC Diagnostics Ltd. to verify smoking status. A color change to red/orange indicates a positive sample, with a darker color indicating greater nicotine intake. | baseline |
| Number of Participants With Color Change for Urine Test for Measuring Cotinine | A point of care urine test for measuring cotinine will also be conducted via the SmokeScreen® test from GFC Diagnostics Ltd. to verify smoking status. A color change to red/orange indicates a positive sample, with a darker color indicating greater nicotine intake. | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Reasons for Quitting Scale | We used the Reasons for Quitting (RFQ) scale to measure motivation to quit smoking. The scale is used to measure intrinsic and extrinsic motivation for quitting smoking. Each item in the scale is evaluated using a 5-point Likert scale regarding how true the statement is about the participant's motivation to quit smoking (Not at all true, a little bit true, moderately true, quite true, extremely true). Each option takes on a numerical score from 0 (not at all true) to 4 (extremely true). Scores are summed across all items in the scale and divided by the number of items in the scale to obtain the RFQ score. The range of possible scores is 0 to 4. A higher score indicates greater motivation to quit smoking. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jonathan E Golub, PhD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins University School of Medicine | Baltimore | Maryland | 21231 | United States |
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| Label | URL |
|---|---|
| 5 As: Treating Tobacco Use and Dependence | View source |
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160 participants were assessed for eligibility, 58 did not meet inclusion criteria
Participants were recruited through posters advertising the study around the Johns Hopkins Medical Institutions East Baltimore campus, including clinics, inpatient and outpatient facilities, and through participant referrals.
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| ID | Title | Description |
|---|---|---|
| FG000 | Control | A certified smoking cessation interventionist (SCI) will deliver standardized smoking cessation counseling using the National Cancer Institute (NCI) 5 A's model. Cessation counseling: The advice to quit smoking message will follow NCI's 5 A's model for smoking cessation counseling. This is a simple smoking cessation counseling strategy with 5 discrete components: (1) Ask about smoking at every opportunity; (2) Advise the patient to quit smoking; (3) Assess readiness to quit; (4) Assist the patient in quitting; and (5) Arrange follow-up. |
| FG001 | COach2Quit | A certified smoking cessation interventionist (SCI) will deliver standardized smoking cessation counseling using the National Cancer Institute's 5 A's model. Participants in the COach2Quit arm will be provided with an individualized carbon monoxide (iCO) monitor along with instructions on the use of the monitor and the COach2Quit application. Individualized carbon monoxide (iCO) monitor: a personal monitor for a breath test for carbon monoxide (CO) COach2Quit smartphone application: This smartphone application works in conjunction with the iCO monitor Cessation counseling: The advice to quit smoking message will follow NCI's 5 A's model for smoking cessation counseling. This is a simple smoking cessation counseling strategy with 5 discrete components: (1) Ask about smoking at every opportunity; (2) Advise the patient to quit smoking; (3) Assess readiness to quit; (4) Assist the patient in quitting; and (5) Arrange follow-up. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Control | A certified smoking cessation interventionist (SCI) will deliver standardized smoking cessation counseling using the National Cancer Institute (NCI) 5 A's model. Cessation counseling: The advice to quit smoking message will follow NCI's 5 A's model for smoking cessation counseling. This is a simple smoking cessation counseling strategy with 5 discrete components: (1) Ask about smoking at every opportunity; (2) Advise the patient to quit smoking; (3) Assess readiness to quit; (4) Assist the patient in quitting; and (5) Arrange follow-up. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Smoking Status Using a Point of Care Test for Measuring Carbon Monoxide (CO) | A point of care test for measuring carbon monoxide (CO) will be conducted via the piCO Smokerlyzer from OPS Medical, designed specifically for smoking cessation programs and tobacco control programs. Carbon monoxide will be measured in an exhaled breath in parts-per-million (ppm). A reading of ≤ 10ppm will indicate abstinence. | Thirteen participants were lost to follow-up (9 at the 14-day visit and 4 at the 30-day visit) and the sample size for the analysis was 89. There were no significant differences in baseline characteristics between participants lost to follow-up and participants who completed the study. | Posted | Median | Inter-Quartile Range | parts per million | baseline |
|
6 months (May - November 2017)
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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 | Control | A certified smoking cessation interventionist (SCI) will deliver standardized smoking cessation counseling using the National Cancer Institute (NCI) 5 A's model. Cessation counseling: The advice to quit smoking message will follow NCI's 5 A's model for smoking cessation counseling. This is a simple smoking cessation counseling strategy with 5 discrete components: (1) Ask about smoking at every opportunity; (2) Advise the patient to quit smoking; (3) Assess readiness to quit; (4) Assist the patient in quitting; and (5) Arrange follow-up. |
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Limitations of the study include small sample size, short follow-up duration and large loss to follow-up. Self-reported measures could be subject to recall bias and social desirability bias. We also did not collect information on substance use.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jonathan E. Golub | Johns Hopkins University School of Medicine | (443) 287-2969 | jgolub@jhmi.edu |
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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 | May 15, 2017 | Aug 23, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D012907 | Smoking |
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D015438 | Health Behavior |
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| ID | Term |
|---|---|
| D008991 | Monitoring, Physiologic |
| ID | Term |
|---|---|
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| COach2Quit smartphone application | Other | This smartphone application works in conjunction with the iCO monitor |
|
| Cessation counseling | Behavioral | The advice to quit smoking message will follow NCI's 5 A's model for smoking cessation counseling. This is a simple smoking cessation counseling strategy with 5 discrete components: (1) Ask about smoking at every opportunity; (2) Advise the patient to quit smoking; (3) Assess readiness to quit; (4) Assist the patient in quitting; and (5) Arrange follow-up. |
|
| baseline |
| BG001 | COach2Quit | A certified smoking cessation interventionist (SCI) will deliver standardized smoking cessation counseling using the National Cancer Institute's 5 A's model. Participants in the COach2Quit arm will be provided with an individualized carbon monoxide (iCO) monitor along with instructions on the use of the monitor and the COach2Quit application. Individualized carbon monoxide (iCO) monitor: a personal monitor for a breath test for carbon monoxide (CO) COach2Quit smartphone application: This smartphone application works in conjunction with the iCO monitor Cessation counseling: The advice to quit smoking message will follow NCI's 5 A's model for smoking cessation counseling. This is a simple smoking cessation counseling strategy with 5 discrete components: (1) Ask about smoking at every opportunity; (2) Advise the patient to quit smoking; (3) Assess readiness to quit; (4) Assist the patient in quitting; and (5) Arrange follow-up. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| Education | Count of Participants | Participants |
|
| Employment | Count of Participants | Participants |
|
| Cigarettes smoked per day | Median | Inter-Quartile Range | cigarettes |
|
| Quit attempts in past 12 months | Median | Inter-Quartile Range | attempts |
|
| Fagerström Test for Nicotine Dependence | We used the Fagerstrom Test for Nicotine Dependence (FTND) to measure nicotine dependence. The measure consists of 6 Questions. Each question has multiple response options out of which one option must be selected. Each option carries a corresponding numerical score. The scores for each question are summed to obtain a total score. The range of possible scores is 1 to 10, with a higher value indicating greater nicotine dependence (worse outcome). The interpretation of scores is as follows: 1-2: low dependence 3-4: low to moderate dependence 5-7: moderate dependence 8+: high dependence | Mean | Standard Deviation | score |
|
| OG001 | COach2Quit | A certified smoking cessation interventionist (SCI) will deliver standardized smoking cessation counseling using the National Cancer Institute's 5 A's model. Participants in the COach2Quit arm will be provided with an individualized carbon monoxide (iCO) monitor along with instructions on the use of the monitor and the COach2Quit application. Individualized carbon monoxide (iCO) monitor: a personal monitor for a breath test for carbon monoxide (CO) COach2Quit smartphone application: This smartphone application works in conjunction with the iCO monitor Cessation counseling: The advice to quit smoking message will follow NCI's 5 A's model for smoking cessation counseling. This is a simple smoking cessation counseling strategy with 5 discrete components: (1) Ask about smoking at every opportunity; (2) Advise the patient to quit smoking; (3) Assess readiness to quit; (4) Assist the patient in quitting; and (5) Arrange follow-up. |
|
|
| Primary | Smoking Status Using a Point of Care Test for Measuring Carbon Monoxide (CO) | A point of care test for measuring carbon monoxide (CO) will be conducted via the piCO Smokerlyzer from OPS Medical, designed specifically for smoking cessation programs and tobacco control programs. Carbon monoxide will be measured in an exhaled breath in parts-per-million (ppm). A reading of ≤ 10ppm will indicate abstinence. | Thirteen participants were lost to follow-up (9 at the 14-day visit and 4 at the 30-day visit) and the sample size for the analysis was 89. There were no significant differences in baseline characteristics between participants lost to follow-up and participants who completed the study. | Posted | Median | Inter-Quartile Range | parts per million | 1 month |
|
|
|
| Primary | Number of Participants With Color Change for Urine Test for Measuring Cotinine | A point of care urine test for measuring cotinine will also be conducted via the SmokeScreen® test from GFC Diagnostics Ltd. to verify smoking status. A color change to red/orange indicates a positive sample, with a darker color indicating greater nicotine intake. | Thirteen participants were lost to follow-up (9 at the 14-day visit and 4 at the 30-day visit) and the sample size for the analysis was 89. There were no significant differences in baseline characteristics between participants lost to follow-up and participants who completed the study. | Posted | Number | participants | baseline |
|
|
|
| Primary | Number of Participants With Color Change for Urine Test for Measuring Cotinine | A point of care urine test for measuring cotinine will also be conducted via the SmokeScreen® test from GFC Diagnostics Ltd. to verify smoking status. A color change to red/orange indicates a positive sample, with a darker color indicating greater nicotine intake. | Thirteen participants were lost to follow-up (9 at the 14-day visit and 4 at the 30-day visit) and the sample size for the analysis was 89. There were no significant differences in baseline characteristics between participants lost to follow-up and participants who completed the study. | Posted | Number | participants | 1 month |
|
|
|
| Secondary | Reasons for Quitting Scale | We used the Reasons for Quitting (RFQ) scale to measure motivation to quit smoking. The scale is used to measure intrinsic and extrinsic motivation for quitting smoking. Each item in the scale is evaluated using a 5-point Likert scale regarding how true the statement is about the participant's motivation to quit smoking (Not at all true, a little bit true, moderately true, quite true, extremely true). Each option takes on a numerical score from 0 (not at all true) to 4 (extremely true). Scores are summed across all items in the scale and divided by the number of items in the scale to obtain the RFQ score. The range of possible scores is 0 to 4. A higher score indicates greater motivation to quit smoking. | Thirteen participants were lost to follow-up (9 at the 14-day visit and 4 at the 30-day visit) and the sample size for the analysis was 89. There were no significant differences in baseline characteristics between participants lost to follow-up and participants who completed the study. | Posted | Mean | 95% Confidence Interval | score on a scale | baseline |
|
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|
| 0 |
| 52 |
| 0 |
| 52 |
| 0 |
| 52 |
| EG001 | COach2Quit | A certified smoking cessation interventionist (SCI) will deliver standardized smoking cessation counseling using the National Cancer Institute's 5 A's model. Participants in the COach2Quit arm will be provided with an individualized carbon monoxide (iCO) monitor along with instructions on the use of the monitor and the COach2Quit application. Individualized carbon monoxide (iCO) monitor: a personal monitor for a breath test for carbon monoxide (CO) COach2Quit smartphone application: This smartphone application works in conjunction with the iCO monitor Cessation counseling: The advice to quit smoking message will follow NCI's 5 A's model for smoking cessation counseling. This is a simple smoking cessation counseling strategy with 5 discrete components: (1) Ask about smoking at every opportunity; (2) Advise the patient to quit smoking; (3) Assess readiness to quit; (4) Assist the patient in quitting; and (5) Arrange follow-up. | 0 | 50 | 0 | 50 | 0 | 50 |
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| Moderate |
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| Heavy |
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| Very Heavy |
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| Missing/could not interpret |
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| Moderate |
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| Heavy |
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| Very Heavy |
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| Missing/could not interpret |
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