COach2Quit TRIAL: Assessing a Prototype Personal Carbon Monoxide Monitor for Smoking Cessation

Smoking Cessation Clinical Trial

— C2Q  

Official title:

COach2Quit TRIAL: Assessing a Prototype Personal Carbon Monoxide Monitor for Smoking Cessation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03142932
• Other study ID #: IRB00124820
• Status: Completed
• Phase: N/A
• Start date: May 17, 2017
• Est. completion date: November 30, 2017

Study information

• Verified date: October 2019
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: November 30, 2017
• Est. primary completion date: November 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Smoking
• Smoking Cessation

Intervention

Device:
• Individualized carbon monoxide (iCO) monitor
a personal monitor for a breath test for carbon monoxide (CO)

Other:
• COach2Quit smartphone application
This smartphone application works in conjunction with the iCO monitor

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Johns Hopkins University School of Medicine	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	Maryland Department of Health and Mental Hygiene

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	baseline
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.	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.	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.	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.	baseline

External Links

•   5 As: Treating Tobacco Use and Dependence