Smoking, Smoking Cessation
Conditions
Keywords
smoking
Brief summary
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.
Detailed description
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.
Interventions
DEVICEIndividualized carbon monoxide (iCO) monitor
a personal monitor for a breath test for carbon monoxide (CO)
OTHERCOach2Quit smartphone application
This smartphone application works in conjunction with the iCO monitor
BEHAVIORALCessation 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.
Sponsors
Maryland Department of Health and Mental Hygiene
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* ≥18 years of age * current, daily smokers * agree to participate and anticipate to be living in Baltimore for at least 2 months * own a phone that is compatible with the app * be willing to set at baseline assessment a quit date within 2 weeks
Exclusion criteria
* are suffering from any unstable medical condition precluding the use of the CO monitor (e.g. severe COPD) * are currently using smokeless tobacco including e-cigarettes * are currently using nicotine replacement therapy or other smoking cessation treatment * are pregnant, determined by participant self-report * have a negative baseline result on both urine cotinine AND CO monitor
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Smoking Status Using a Point of Care Test for Measuring Carbon Monoxide (CO) | baseline | 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. |
| Number of Participants With Color Change for Urine Test for Measuring Cotinine | baseline | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reasons for Quitting Scale | baseline | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
160 participants were assessed for eligibility, 58 did not meet inclusion criteria
Participants by arm
| Arm | Count |
|---|---|
| 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. | 52 |
| 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. | 50 |
| Total | 102 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 11 |
Baseline characteristics
| Characteristic | COach2Quit | Total | Control |
|---|---|---|---|
| Age, Continuous | 52 years | 52 years | 51 years |
| Cigarettes smoked per day | 10 cigarettes | 10 cigarettes | 10 cigarettes |
| Education High school or more | 30 Participants | 68 Participants | 38 Participants |
| Education Less than high school | 20 Participants | 34 Participants | 14 Participants |
| Employment Employed (full/part time) | 6 Participants | 19 Participants | 13 Participants |
| Employment Unemployed/don't work | 44 Participants | 83 Participants | 39 Participants |
| Fagerström Test for Nicotine Dependence | 2.54 score STANDARD_DEVIATION 1.43 | 2.69 score STANDARD_DEVIATION 1.47 | 2.85 score STANDARD_DEVIATION 1.51 |
| Quit attempts in past 12 months | 2 attempts | 2 attempts | 2 attempts |
| Race/Ethnicity, Customized Black/African American | 42 Participants | 81 Participants | 39 Participants |
| Race/Ethnicity, Customized Mixed Race/Other | 2 Participants | 5 Participants | 3 Participants |
| Race/Ethnicity, Customized White | 6 Participants | 16 Participants | 10 Participants |
| Region of Enrollment United States | 50 participants | 102 participants | 52 participants |
| Sex: Female, Male Female | 28 Participants | 59 Participants | 31 Participants |
| Sex: Female, Male Male | 22 Participants | 43 Participants | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 52 | 0 / 50 |
| other Total, other adverse events | 0 / 52 | 0 / 50 |
| serious Total, serious adverse events | 0 / 52 | 0 / 50 |
Outcome results
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.
Time frame: baseline
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Control | Number of Participants With Color Change for Urine Test for Measuring Cotinine | Normal / no change | 1 participants |
| Control | Number of Participants With Color Change for Urine Test for Measuring Cotinine | Light | 13 participants |
| Control | Number of Participants With Color Change for Urine Test for Measuring Cotinine | Moderate | 11 participants |
| Control | Number of Participants With Color Change for Urine Test for Measuring Cotinine | Heavy | 8 participants |
| Control | Number of Participants With Color Change for Urine Test for Measuring Cotinine | Very Heavy | 12 participants |
| Control | Number of Participants With Color Change for Urine Test for Measuring Cotinine | Missing/could not interpret | 5 participants |
| COach2Quit | Number of Participants With Color Change for Urine Test for Measuring Cotinine | Very Heavy | 5 participants |
| COach2Quit | Number of Participants With Color Change for Urine Test for Measuring Cotinine | Normal / no change | 1 participants |
| COach2Quit | Number of Participants With Color Change for Urine Test for Measuring Cotinine | Heavy | 14 participants |
| COach2Quit | Number of Participants With Color Change for Urine Test for Measuring Cotinine | Light | 2 participants |
| COach2Quit | Number of Participants With Color Change for Urine Test for Measuring Cotinine | Missing/could not interpret | 4 participants |
| COach2Quit | Number of Participants With Color Change for Urine Test for Measuring Cotinine | Moderate | 13 participants |
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.
Time frame: 1 month
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Control | Number of Participants With Color Change for Urine Test for Measuring Cotinine | Light | 6 participants |
| Control | Number of Participants With Color Change for Urine Test for Measuring Cotinine | Heavy | 13 participants |
| Control | Number of Participants With Color Change for Urine Test for Measuring Cotinine | Normal / no change | 1 participants |
| Control | Number of Participants With Color Change for Urine Test for Measuring Cotinine | Very Heavy | 10 participants |
| Control | Number of Participants With Color Change for Urine Test for Measuring Cotinine | Moderate | 11 participants |
| Control | Number of Participants With Color Change for Urine Test for Measuring Cotinine | Missing/could not interpret | 9 participants |
| COach2Quit | Number of Participants With Color Change for Urine Test for Measuring Cotinine | Missing/could not interpret | 9 participants |
| COach2Quit | Number of Participants With Color Change for Urine Test for Measuring Cotinine | Normal / no change | 1 participants |
| COach2Quit | Number of Participants With Color Change for Urine Test for Measuring Cotinine | Light | 2 participants |
| COach2Quit | Number of Participants With Color Change for Urine Test for Measuring Cotinine | Moderate | 10 participants |
| COach2Quit | Number of Participants With Color Change for Urine Test for Measuring Cotinine | Heavy | 12 participants |
| COach2Quit | Number of Participants With Color Change for Urine Test for Measuring Cotinine | Very Heavy | 5 participants |
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.
Time frame: baseline
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Control | Smoking Status Using a Point of Care Test for Measuring Carbon Monoxide (CO) | 22.0 parts per million |
| COach2Quit | Smoking Status Using a Point of Care Test for Measuring Carbon Monoxide (CO) | 23.0 parts per million |
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.
Time frame: 1 month
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Control | Smoking Status Using a Point of Care Test for Measuring Carbon Monoxide (CO) | 18.5 parts per million |
| COach2Quit | Smoking Status Using a Point of Care Test for Measuring Carbon Monoxide (CO) | 19.5 parts per million |
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.
Time frame: baseline
Population: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Control | Reasons for Quitting Scale | 2.6 score on a scale |
| COach2Quit | Reasons for Quitting Scale | 2.6 score on a scale |