Telehealth Smoking Cessation for Quitting Smoking

(E-STOP Trial)

Overseen By Noelle E Natale

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Medical University of South Carolina

Must not be taking: Cessation medications

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

Compensation: Varies

Number of Visits: 4

Duration: 24 weeks

672 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the effectiveness of an online visit, or e-visit, in helping people quit smoking. Participants will be divided into two groups: one will use the Smoking cessation e-visit, which includes questionnaires about smoking habits and motivation to quit, while the other will receive standard advice and resources for quitting smoking. Some participants in the e-visit group may receive a prescription for a quit-smoking medication, though taking medication is not required. This trial suits current smokers who have smoked at least one cigarette a day for most of the past six months and have access to a smartphone and email. As an unphased trial, it offers a unique opportunity to explore innovative ways to quit smoking with flexible participation.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot have used an FDA-approved smoking cessation medication in the last 7 days before joining.

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

Research has shown that online tools for quitting smoking, such as the smoking cessation e-visit, can help people quit more effectively than some traditional methods. These tools are generally easy to use, and studies indicate they can increase quit rates without major safety concerns. While using nicotine products like e-cigarettes carries risks, the e-visit itself does not involve taking any specific medication. It primarily involves answering questions about smoking habits and preferences, which is safe. Participants may receive a prescription for a smoking cessation medication if desired, but it is not required. Based on current research, the e-visit itself is considered safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Telehealth Smoking Cessation approach because it leverages electronic visits (e-visits) to enhance accessibility and convenience for individuals looking to quit smoking. Unlike traditional methods, which often require in-person visits and consultations, this method allows participants to receive guidance and support from the comfort of their home through digital means. This approach has the potential to reach more people, particularly those who may face barriers to accessing traditional healthcare settings. Additionally, the follow-up e-visit encourages sustained engagement, which could lead to higher success rates in quitting smoking.

What evidence suggests that this trial's treatments could be effective for quitting smoking?

Research shows that online visits can help people quit smoking. In this trial, participants in the "Smoking cessation electronic visit (e-visit)" arm will receive personalized online programs, which studies have found improve quit rates more than usual methods. A review of research has found that online tools and resources increase the chances of quitting smoking. This approach offers an easy and active way for people to get support in their efforts to stop smoking. Overall, early findings suggest that e-visits can be a promising tool in helping people quit smoking. Meanwhile, participants in the "Treatment as usual (TAU)" arm will receive information about the state quitline and recommendations to contact their PCP for further support. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults who smoke at least 5 cigarettes a day, are fluent in English, have daily email access, and own a smartphone. They must be enrolled or willing to enroll in MyChart with a valid address. It's not for those who've used FDA-approved quitting meds recently.

Inclusion Criteria

I check my email daily with a valid email address.

Have a valid mailing address

English fluency

Exclusion Criteria

I have used a quit-smoking medication approved by the FDA in the past week.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomly assigned to receive either the smoking cessation e-visit or not, with e-visits including questionnaires and potential prescriptions for smoking cessation medication.

24 weeks

4 visits (virtual)

Follow-up

Participants are monitored for smoking cessation outcomes, including medication adoption, treatment utilization, and smoking reduction.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Smoking cessation e-visit
• Treatment As Usual

Trial Overview The study tests an e-visit system designed to help people quit smoking against the usual treatment methods. Participants will either receive this innovative online support tool or continue with standard care without the e-visit intervention.

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+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

A study involving 554 smokers showed that a Telehealth videoconferencing smoking cessation program for rural participants achieved continuous abstinence rates of 25.5%, comparable to 27.5% for urban participants, indicating its effectiveness.

The program maintained similar quit rates over a 12-month follow-up, demonstrating that remote access to behavioral smoking cessation interventions can be as effective as in-person programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telehealth-delivered group smoking cessation for rural and urban participants: feasibility and cessation rates. Carlson, LE., Lounsberry, JJ., Maciejewski, O., 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 Internet-based smoking cessation intervention combined with a tele-health medication clinic had a greater reach and higher use of smoking cessation aids compared to traditional clinic-based care, involving 413 patients over a 12-month period.

Despite the increased reach, the quit rates at both 3 months (17% vs. 12%) and 12 months (13% vs. 16%) were not significantly different between the Internet intervention and the control group, indicating that more effective strategies are needed to improve smoking cessation outcomes in veterans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative Effectiveness of an Internet-Based Smoking Cessation Intervention Versus Clinic-Based Specialty Care for Veterans. Calhoun, PS., Datta, S., Olsen, M., et al.[2022]

The Decide2Quit program, a tailored web-based and e-message smoking cessation intervention, is being tested on 1,488 hospitalized smokers to evaluate its effectiveness in promoting tobacco cessation after discharge.

The primary outcome of the study is self-reported 30-day tobacco abstinence at 6 months, with secondary outcomes including various quit rates and cost-effectiveness assessments, highlighting the program's potential for broad implementation with minimal burden on hospital staff.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Web-based smoking cessation intervention that transitions from inpatient to outpatient: study protocol for a randomized controlled trial. Harrington, KF., McDougal, JA., Pisu, M., et al.[2021]

Telephonic tobacco cessation coaching significantly improved quit rates among participants (31%) compared to matched controls (23%), demonstrating its effectiveness in real-world clinical settings.

Participants in the coaching program also filled prescriptions for tobacco cessation medications at a much higher rate (47%) than those who received no treatment (6%), indicating that the coaching not only helped with quitting but also encouraged the use of cessation aids.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telephone-Based Coaching. Boccio, M., Sanna, RS., Adams, SR., et al.[2022]

Approximately 1.6% to 2.5% of adult smokers expressed interest and enrolled in Project Quit, an online smoking cessation program, indicating a notable interest in digital support for quitting smoking.

Proactive recruitment methods, such as invitation letters sent to likely smokers, were significantly more effective than other strategies, leading to 69% of website visitors and 68% of enrollees, highlighting the importance of targeted outreach in engaging smokers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interest in an online smoking cessation program and effective recruitment strategies: results from Project Quit. McClure, JB., Greene, SM., Wiese, C., et al.[2022]

In a study of 837 daily smokers, those receiving telephone care had a significantly higher 6-month smoking cessation rate (13.0%) compared to those receiving standard care (4.1%), indicating that telephone counseling is a more effective intervention.

Participants in the telephone care group were much more likely to engage in counseling programs (97.1% vs 24.0%) and use smoking cessation medications (89.6% vs 52.3%), suggesting that telephone care enhances both behavioral and pharmacological support for quitting smoking.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Benefits of telephone care over primary care for smoking cessation: a randomized trial. An, LC., Zhu, SH., Nelson, DB., et al.[2022]

A personalized and automated Internet-based smoking cessation program (e-coaching) showed a higher cessation rate at 3 months compared to a control group receiving a smoking cessation booklet, with 27.5% of e-coaching participants abstaining versus 23.5% in the control group.

While the e-coaching program was effective in the short term, its superiority over the booklet diminished at 6 and 12 months, indicating that while it can provide immediate support, long-term effectiveness may require additional strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of a Fully Automated Internet-Based Smoking Cessation Program: A Randomized Controlled Trial (STAMP). Nguyen Thanh, V., Guignard, R., Lancrenon, S., et al.[2020]

Web-based and mobile health (mHealth) interventions significantly improve smoking cessation rates, with risk ratios of 2.03 and 1.71 respectively, based on a review of 108 studies involving over 110,000 participants.

Tailored text messaging and web-based information combined with nicotine replacement therapy also enhance cessation success, while daily text messages were found to be less effective than weekly ones, highlighting the importance of intervention design.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Which eHealth interventions are most effective for smoking cessation? A systematic review. Do, HP., Tran, BX., Le Pham, Q., et al.[2022]

The study evaluated the effects of five different smoking cessation interventions on 1,034 smokers, revealing that both the National Cancer Institute's website and nicotine replacement therapy (NRT) significantly increased smoking abstinence rates.

However, the effectiveness of the NCI website was reduced when combined with motivational email messages, indicating that certain interventions may interact negatively with each other.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Five population-based interventions for smoking cessation: a MOST trial. Fraser, D., Kobinsky, K., Smith, SS., et al.[2022]

The study evaluated an asynchronous smoking cessation e-visit for adult smokers in primary care, involving 51 participants, and found it to be acceptable and feasible, with high satisfaction rates among users.

The e-visit showed promising efficacy in improving smoking cessation outcomes compared to standard treatment, with participants having higher odds of quitting at both 1 month (ORs: 2.10-5.39) and 3 months (ORs: 1.31-4.67) post-enrollment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a Proactive Smoking Cessation Electronic Visit to Extend the Reach of Evidence-Based Cessation Treatment via Primary Care. Dahne, J., Player, M., Carpenter, MJ., et al.[2022]

A quit-line for smoking cessation in Iran successfully helped 122 out of 148 participants (82.4%) quit smoking, demonstrating the efficacy of telephone counseling for smokers who cannot attend in-person programs.

The program showed a sustained abstinence rate of 59% after 1 month, which decreased over time, indicating that while initial success is high, ongoing support is crucial for long-term cessation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of telephone quit-line for smokers in iran: 12 months follow up results. Heydari, G., Jianfar, G., Alvanpour, A., et al.[2021]

Citations

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Health Effects of Vaping | Smoking and Tobacco Use No tobacco products, including e-cigarettes, are safe. · Most e-cigarettes contain nicotine, which is highly addictive and is a health danger for ...