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

144 Participants Needed

Trial Summary

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 data supports the effectiveness of the smoking cessation e-visit treatment for COPD?

Research shows that quitting smoking is the most effective way to slow down lung damage and improve survival in people with COPD. Studies also recommend using a combination of counseling and medication to help people stop smoking, which is similar to the approach used in the smoking cessation e-visit treatment. ^{1 2 3 4 5}

Is the Smoking Cessation E-Visit for COPD safe?

The safety of the Smoking Cessation E-Visit for COPD is not directly addressed in the available research, but e-cigarettes, which are sometimes used in smoking cessation, have been linked to lung injuries. Therefore, caution is advised when considering e-cigarettes as part of a smoking cessation strategy. ^{1 6 7 8 9}

How is the Smoking Cessation E-Visit treatment different from other treatments for COPD?

The Smoking Cessation E-Visit is unique because it is an online program that combines smoking cessation support with COPD screening, allowing for proactive and integrated care for smokers at risk of COPD, unlike traditional treatments that may focus solely on smoking cessation or require in-person visits. ^{1 3 5 10 11}

What is the purpose of this trial?

The purpose of this study is to evaluate an electronic visit (e-visit) for COPD screening and for quitting smoking. Participants will be randomly assigned to receive either the smoking cessation e-visit or not. The e-visit will look similar to an online questionnaire asking about smoking history, preferences for cessation medications, and chronic COPD symptoms. Participants may receive a prescription for a smoking cessation medication as an outcome of the e-visit, if randomized to the e-visit group, but there is no requirement to take any medication. This study consists of questionnaires and breath samples provided at 4 separate time points throughout the study. Participation in this study will take about 24 weeks.

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. Canada pubmed.ncbi.nlm.nih.gov

Proactive Electronic Visits for Smoking Cessation and Chronic Obstructive Pulmonary Disease Screening in Primary Care: Randomized Controlled Trial of Feasibility, Acceptability, and Efficacy. [2022]

2. England pubmed.ncbi.nlm.nih.gov

COPD-related morbidity and mortality after smoking cessation: status of the evidence. [2022]

3. Germany pubmed.ncbi.nlm.nih.gov

[Smoking Cessation in Patients with COPD]. [2023]

4. Spain pubmed.ncbi.nlm.nih.gov

Using PICO Methodology to Answer Questions About Smoking in COPD Patients. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Respiratory and Bronchitic Symptoms Predict Intention to Quit Smoking among Current Smokers with, and at Risk for, Chronic Obstructive Pulmonary Disease. [2018]

6. England 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. [2022]

7. Canada pubmed.ncbi.nlm.nih.gov

Impact of Baseline Assessment Modality on Enrollment and Retention in a Facebook Smoking Cessation Study. [2018]

8. Canada 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. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Smoking Addiction and Strategies for Cessation. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

Smoking cessation. [2019]

11. England pubmed.ncbi.nlm.nih.gov

Smoking cessation and vaccination. [2023]