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

NCT ID: NCT03142932

Last Updated: 2019-10-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-17
• Study Completion Date: 2017-11-30

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.

Conditions

Smoking; Smoking Cessation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control

A certified smoking cessation interventionist (SCI) will deliver standardized smoking cessation counseling using the National Cancer Institute (NCI) 5 A's model.

Group Type: ACTIVE_COMPARATOR

Cessation counseling

Intervention Type: 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

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.

Group Type: EXPERIMENTAL

Individualized carbon monoxide (iCO) monitor

Intervention Type: DEVICE

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

COach2Quit smartphone application

Intervention Type: OTHER

This smartphone application works in conjunction with the iCO monitor

Cessation counseling

Intervention Type: 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.

Interventions

Individualized carbon monoxide (iCO) monitor

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

Intervention Type: DEVICE

COach2Quit smartphone application

This smartphone application works in conjunction with the iCO monitor

Intervention Type: OTHER

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Maryland Department of Health and Mental Hygiene

OTHER_GOV

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jonathan E Golub, PhD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Johns Hopkins University School of Medicine

Baltimore, Maryland, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

IRB00124820

Identifier Type: -

Identifier Source: org_study_id