Smoking Cessation E-Visit for COPD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Medical University of South Carolina

Disqualifiers: COPD

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate whether an electronic visit (e-visit) can assist with quitting smoking and detecting chronic obstructive pulmonary disease (COPD). Participants will either use this smoking cessation e-visit, which involves online questions about smoking habits and COPD symptoms and may lead to a smoking cessation medication prescription, or they will receive standard guidance on quitting smoking. This process includes providing breath samples and completing questionnaires over 24 weeks. It suits individuals who smoke at least one cigarette a day and are enrolled in MyChart, with no prior COPD diagnosis. As an unphased trial, this study offers a unique opportunity to explore innovative methods for smoking cessation and COPD detection.

Do I need to stop my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, since the study involves smoking cessation and COPD screening, it's best to discuss your current medications with the study team.

What prior data suggests that this e-visit is safe for smoking cessation?

A previous study tested an online questionnaire for quitting smoking with individuals who have COPD, a lung disease that makes breathing difficult. The study found this type of online visit generally safe. Researchers assessed how well participants managed the online process, rather than any specific medication. Since the study involves filling out questionnaires and possibly receiving advice on quitting smoking, no serious side effects were reported from the online visit itself.

This trial does not test new drugs or treatments, only the online visit method, so safety concerns remain low. It primarily focuses on gathering information and supporting smoking cessation through online means. Participants might receive a prescription for a medication to aid in quitting smoking, but taking it is not required. The main focus is on the safety of the online visit process, which other research has shown to be safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the smoking cessation e-visit for COPD because it offers a fresh, digital twist to quitting smoking. Unlike standard methods like nicotine replacement therapies or in-person counseling, this approach leverages online visits to provide personalized support and guidance. The e-visit format is not only convenient, allowing participants to access help from the comfort of their homes, but it also enables timely follow-ups, enhancing the chances of successful quitting. This digital engagement could revolutionize how support is delivered, making it accessible to more people and potentially boosting quit rates.

What evidence suggests that the smoking cessation e-visit is effective for quitting smoking in COPD patients?

Research shows that online visits, or e-visits, can help people quit smoking. These e-visits involve filling out questionnaires and discussing smoking habits, which can aid those trying to stop smoking. For individuals with chronic obstructive pulmonary disease (COPD), quitting smoking is crucial. In this trial, one group will receive smoking cessation e-visits, which have proven both feasible and effective for people with COPD. During these e-visits, nicotine replacement therapies are often discussed, and they have been particularly helpful in achieving long-term smoking cessation. This evidence suggests that e-visits could be a promising option for anyone looking to quit smoking, especially those with COPD. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for current smokers aged 40 and above who smoke more than 5 cigarettes daily. Participants must be enrolled or willing to enroll in the Epic's MyChart program, have a smartphone compatible with iOS or Android for remote readings, check their email daily, speak English fluently, and have a valid mailing address.

Inclusion Criteria

I am 40 years old or older.

Owner of an iOS or Android compatible smartphone to provide remote CO readings

Have a valid address at which mail can be received (for mailing iCO™)

Exclusion Criteria

I have been diagnosed with COPD.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

E-Visit Intervention

Participants complete an electronic visit (e-visit) focused on cigarette smoking and COPD screening. They may receive a prescription for smoking cessation medication.

4 weeks

1 e-visit

Follow-up E-Visit

Participants complete a follow-up e-visit one month after the initial e-visit to assess smoking cessation progress.

4 weeks

1 e-visit

Follow-up

Participants are monitored for smoking cessation and COPD symptoms, with biochemical verification of smoking status.

16 weeks

2 visits (in-person or virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Smoking cessation e-visit

Trial Overview The study is testing an e-visit system designed to help people quit smoking by screening for COPD symptoms and advising on cessation methods. Some participants will receive this e-visit while others won't. The study involves questionnaires and breath samples over a period of about 24 weeks.

How Is the Trial Designed?

Group I: Smoking cessation electronic visit (e-visit) Experimental Treatment 1 Intervention

This group will be sent 1) an invitation to complete an electronic visit (e-visit) focused on cigarette smoking and 2) an invitation to complete a follow-up e-visit one-month after the initial e-visit.

Group II: Treatment as usual (TAU) Active Control 1 Intervention

This group will be provided information about the state quitline and about the importance of quitting smoking and it will be recommended that they contact their PCP to schedule a medical visit to discuss quitting smoking.

Smoking cessation e-visit is already approved in United States for the following indications:

Approved in United States as Smoking Cessation e-visit for:

• Smoking cessation

Who Is Running the Clinical Trial?

Medical University of South Carolina

Lead Sponsor

Trials

994

Recruited

7,408,000+

Published Research Related to This Trial

This pilot study involves 60 COPD patients and compares the effectiveness of standard smoking cessation care (counseling and nicotine replacement therapy) with counseling plus electronic cigarettes (EC) over 12 weeks, aiming to identify barriers and facilitators to EC use.

The study seeks to assess the feasibility and acceptability of EC as a harm reduction strategy, with the potential to help COPD patients reduce their cigarette consumption or quit smoking altogether, addressing a significant health need for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electronic cigarettes as a harm reduction strategy among patients with COPD: protocol for an open-label two arm randomized controlled pilot trial. Stevens, ER., Lei, L., Cleland, CM., et al.[2022]

The Techniker Krankenkasse Smoking Cessation Coaching (TK-SCC) program showed a smoking abstinence rate of 11.9% at 12 months, which is comparable to other effective interventions, but did not significantly outperform a minimal control intervention in the long term.

Higher intensity of use of the TK-SCC program was associated with greater success in quitting smoking, indicating that encouraging consistent engagement with the program could enhance its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effect of Interactivity, Tailoring, and Use Intensity on the Effectiveness of an Internet-Based Smoking Cessation Intervention Over a 12-Month Period: Randomized Controlled Trial. Maiwald, P., Bischoff, M., Lindinger, P., et al.[2023]

In a study comparing web-based and phone-based assessments for a Facebook smoking cessation program, the web-based approach resulted in significantly higher enrollment rates (67.9% vs. 32.7%) and lower costs per participant ($27 for WEB vs. $87 for PH).

Despite the differences in enrollment rates, both methods had similar follow-up completion rates (43% for WEB and 46% for PH), indicating that while web-based assessments are more effective for enrollment, they do not compromise participant retention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of Baseline Assessment Modality on Enrollment and Retention in a Facebook Smoking Cessation Study. Villanti, AC., Jacobs, MA., Zawistowski, G., et al.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9472044/

Proactive Electronic Visits for Smoking Cessation and Chronic ... The purpose of this study was to preliminarily evaluate an integrated asynchronous smoking cessation and COPD screening e-visit (electronic visit)

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36040766/

Proactive Electronic Visits for Smoking Cessation and Chronic ... A proactive, asynchronous e-visit for smoking cessation and COPD screening may offer a feasible, efficacious approach for broad interventions within primary ...

3. isrctn.com isrctn.com/ISRCTNISRCTN82413824

Effectiveness of electronic cigarettes compared with ... Effectiveness of electronic cigarettes compared with combination nicotine replacement therapy for smoking cessation in patients with chronic obstructive ...

4. nejm.org nejm.org/doi/full/10.1056/NEJMoa2308815

Electronic Nicotine-Delivery Systems for Smoking Cessation A sufficiently powered randomized trial and a systematic review of randomized, controlled trials showed that e-cigarettes were more effective ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S0954611104002288

The efficacy of smoking cessation strategies in people with ... The most effective intervention for prolonged smoking cessation in patients with COPD is the combination of nicotine replacement therapy.

6. withpower.com withpower.com/trial/phase-smoking-cessation-1-2024-c5fbf

Smoking Cessation E-Visit for COPD · Info for Participants The e-visit will look similar to an online questionnaire asking about smoking history, preferences for cessation medications, and chronic COPD symptoms.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11464802/

Smoking cessation program preferences of individuals with ... This research is aimed at describing the attitudes and preferences of COPD and ACO patients toward innovative, telehealth-based smoking cessation strategies.

8. respiratory-research.biomedcentral.com respiratory-research.biomedcentral.com/articles/10.1186/s12931-024-03087-4

Association of e-cigarette and cigarette use with self-reported ... Current e-cigarette use among former cigarette smokers was associated with significantly higher COPD prevalence compared to never e-cigarette use.