Trial Outcomes & Findings for COach2Quit TRIAL: Assessing a Prototype Personal Carbon Monoxide Monitor for Smoking Cessation (NCT NCT03142932)
NCT ID: NCT03142932
Last Updated: 2019-10-04
Results Overview
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.
COMPLETED
NA
102 participants
baseline
2019-10-04
Participant Flow
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.
160 participants were assessed for eligibility, 58 did not meet inclusion criteria
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
52
|
50
|
|
Overall Study
COMPLETED
|
50
|
39
|
|
Overall Study
NOT COMPLETED
|
2
|
11
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
11
|
Baseline Characteristics
COach2Quit TRIAL: Assessing a Prototype Personal Carbon Monoxide Monitor for Smoking Cessation
Baseline characteristics by cohort
| Measure |
Control
n=52 Participants
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.
|
COach2Quit
n=50 Participants
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.
|
Total
n=102 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
51 years
n=5 Participants
|
52 years
n=7 Participants
|
52 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
10 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black/African American
|
39 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
81 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Mixed Race/Other
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
52 participants
n=5 Participants
|
50 participants
n=7 Participants
|
102 participants
n=5 Participants
|
|
Education
Less than high school
|
14 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Education
High school or more
|
38 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
|
Employment
Employed (full/part time)
|
13 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Employment
Unemployed/don't work
|
39 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
83 Participants
n=5 Participants
|
|
Cigarettes smoked per day
|
10 cigarettes
n=5 Participants
|
10 cigarettes
n=7 Participants
|
10 cigarettes
n=5 Participants
|
|
Quit attempts in past 12 months
|
2 attempts
n=5 Participants
|
2 attempts
n=7 Participants
|
2 attempts
n=5 Participants
|
|
Fagerström Test for Nicotine Dependence
|
2.85 score
STANDARD_DEVIATION 1.51 • n=5 Participants
|
2.54 score
STANDARD_DEVIATION 1.43 • n=7 Participants
|
2.69 score
STANDARD_DEVIATION 1.47 • n=5 Participants
|
PRIMARY outcome
Timeframe: baselinePopulation: 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.
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.
Outcome measures
| Measure |
Control
n=50 Participants
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.
|
COach2Quit
n=39 Participants
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.
|
|---|---|---|
|
Smoking Status Using a Point of Care Test for Measuring Carbon Monoxide (CO)
|
22.0 parts per million
Interval 14.0 to 30.0
|
23.0 parts per million
Interval 18.0 to 33.0
|
PRIMARY outcome
Timeframe: 1 monthPopulation: 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.
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.
Outcome measures
| Measure |
Control
n=50 Participants
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.
|
COach2Quit
n=39 Participants
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.
|
|---|---|---|
|
Smoking Status Using a Point of Care Test for Measuring Carbon Monoxide (CO)
|
18.5 parts per million
Interval 10.0 to 28.0
|
19.5 parts per million
Interval 15.0 to 26.0
|
PRIMARY outcome
Timeframe: baselinePopulation: 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.
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.
Outcome measures
| Measure |
Control
n=50 Participants
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.
|
COach2Quit
n=39 Participants
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.
|
|---|---|---|
|
Number of Participants With Color Change for Urine Test for Measuring Cotinine
Normal / no change
|
1 participants
|
1 participants
|
|
Number of Participants With Color Change for Urine Test for Measuring Cotinine
Light
|
13 participants
|
2 participants
|
|
Number of Participants With Color Change for Urine Test for Measuring Cotinine
Moderate
|
11 participants
|
13 participants
|
|
Number of Participants With Color Change for Urine Test for Measuring Cotinine
Heavy
|
8 participants
|
14 participants
|
|
Number of Participants With Color Change for Urine Test for Measuring Cotinine
Very Heavy
|
12 participants
|
5 participants
|
|
Number of Participants With Color Change for Urine Test for Measuring Cotinine
Missing/could not interpret
|
5 participants
|
4 participants
|
PRIMARY outcome
Timeframe: 1 monthPopulation: 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.
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.
Outcome measures
| Measure |
Control
n=50 Participants
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.
|
COach2Quit
n=39 Participants
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.
|
|---|---|---|
|
Number of Participants With Color Change for Urine Test for Measuring Cotinine
Missing/could not interpret
|
9 participants
|
9 participants
|
|
Number of Participants With Color Change for Urine Test for Measuring Cotinine
Normal / no change
|
1 participants
|
1 participants
|
|
Number of Participants With Color Change for Urine Test for Measuring Cotinine
Light
|
6 participants
|
2 participants
|
|
Number of Participants With Color Change for Urine Test for Measuring Cotinine
Moderate
|
11 participants
|
10 participants
|
|
Number of Participants With Color Change for Urine Test for Measuring Cotinine
Heavy
|
13 participants
|
12 participants
|
|
Number of Participants With Color Change for Urine Test for Measuring Cotinine
Very Heavy
|
10 participants
|
5 participants
|
SECONDARY outcome
Timeframe: baselinePopulation: 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.
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.
Outcome measures
| Measure |
Control
n=50 Participants
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.
|
COach2Quit
n=39 Participants
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.
|
|---|---|---|
|
Reasons for Quitting Scale
|
2.6 score on a scale
Interval 2.4 to 2.8
|
2.6 score on a scale
Interval 2.4 to 2.8
|
Adverse Events
Control
COach2Quit
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Jonathan E. Golub
Johns Hopkins University School of Medicine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place