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

NCT03142932 | Completed Results FDA Device

• 1 other identifier: IRB00124820
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

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.

Conditions

Smoking; Smoking Cessation

Keywords

smoking

Outcome Measures

Primary Outcomes (4)

• 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

Secondary Outcomes (1)

• Reasons for Quitting Scale

  baseline

Study Arms (2)

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.

Behavioral: Cessation counseling

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.

Device: Individualized carbon monoxide (iCO) monitor; Other: COach2Quit smartphone application; Behavioral: Cessation counseling

Interventions

Individualized carbon monoxide (iCO) monitor DEVICE

a personal monitor for a breath test for carbon monoxide (CO)

COach2Quit

COach2Quit smartphone application OTHER

This smartphone application works in conjunction with the iCO monitor

COach2Quit

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.

COach2Quit; Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead
• Maryland Department of Health and Mental Hygiene: collaborator

Study Sites (1)

Johns Hopkins University School of Medicine

Baltimore, Maryland, 21231, United States

Location

Related Links

• 5 As: Treating Tobacco Use and Dependence

MeSH Terms

Conditions

Smoking; Smoking Cessation

Interventions

Monitoring, Physiologic

Condition Hierarchy (Ancestors)

Behavior; Health Behavior

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

Limitations and Caveats

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.

Results Point of Contact

• Title: Dr. Jonathan E. Golub
• Organization: Johns Hopkins University School of Medicine

jgolub@jhmi.edu

(443) 287-2969

Study Officials

• Jonathan E Golub, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2017
• First Posted: May 8, 2017
• Study Start: May 17, 2017
• Primary Completion: November 30, 2017
• Study Completion: November 30, 2017
• Last Updated: October 4, 2019
• Results First Posted: November 1, 2018

Record last verified: 2019-10

Locations

US (1)