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Completed

NCT Number: NCT03142932

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

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.

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Key information

Conditions

Smoking Behavior Health Behavior Smoking Cessation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins University School of Medicine

Baltimore, Maryland, 21231, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Individualized carbon monoxide (iCO) monitor

Device

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

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.

Primary outcomes

  1. Smoking Status Using a Point of Care Test for Measuring Carbon Monoxide (CO)

    Time frame: 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.

  2. Smoking Status Using a Point of Care Test for Measuring Carbon Monoxide (CO)

    Time frame: 1 month

    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.

  3. Number of Participants With Color Change for Urine Test for Measuring Cotinine

    Time frame: 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.

  4. Number of Participants With Color Change for Urine Test for Measuring Cotinine

    Time frame: 1 month

    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 outcomes

  1. Reasons for Quitting Scale

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • Maryland Department of Health and Mental Hygiene

Registry information

Acronym: C2Q

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
May 8, 2017
Registry last updated
Oct 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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