672 Participants Needed

Telehealth Smoking Cessation for Quitting Smoking

(E-STOP Trial)

NE
Overseen ByNoelle E Natale
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Medical University of South Carolina
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this research study is to evaluate an electronic visit (e-visit) for smoking cessation. 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, motivation to quit, and preferences for medications for quitting smoking. 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.

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.

Is telehealth smoking cessation generally safe for humans?

The studies reviewed did not report any specific safety concerns related to telehealth smoking cessation programs, suggesting they are generally safe for human use.12345

How is the Telehealth Smoking Cessation treatment different from other smoking cessation treatments?

The Telehealth Smoking Cessation treatment is unique because it uses online and telehealth platforms to provide support, making it accessible for people who cannot attend in-person programs. This approach is particularly beneficial for individuals in rural or remote areas, offering a convenient and flexible alternative to traditional face-to-face or telephone-based support.34678

What data supports the effectiveness of the treatment Telehealth Smoking Cessation for Quitting Smoking?

Research shows that eHealth interventions, like online and telehealth programs, can effectively help people quit smoking by providing personalized support and resources. Internet-based programs have been found to be a promising alternative to traditional face-to-face methods, offering convenience and accessibility.49101112

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
See 3 more

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?
2Treatment groups
Experimental Treatment
Active Control
Group I: Smoking cessation electronic visit (e-visit)Experimental Treatment1 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 Control1 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

Find a Clinic Near You

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

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

Citations

Which eHealth interventions are most effective for smoking cessation? A systematic review. [2022]
Effectiveness of a Fully Automated Internet-Based Smoking Cessation Program: A Randomized Controlled Trial (STAMP). [2020]
Comparative Effectiveness of an Internet-Based Smoking Cessation Intervention Versus Clinic-Based Specialty Care for Veterans. [2022]
Web-based smoking cessation intervention that transitions from inpatient to outpatient: study protocol for a randomized controlled trial. [2021]
Telephone-Based Coaching. [2022]
Evaluation of a Proactive Smoking Cessation Electronic Visit to Extend the Reach of Evidence-Based Cessation Treatment via Primary Care. [2022]
Five population-based interventions for smoking cessation: a MOST trial. [2022]
Telehealth-delivered group smoking cessation for rural and urban participants: feasibility and cessation rates. [2022]
Impact of Baseline Assessment Modality on Enrollment and Retention in a Facebook Smoking Cessation Study. [2018]
Efficacy of telephone quit-line for smokers in iran: 12 months follow up results. [2021]
Interest in an online smoking cessation program and effective recruitment strategies: results from Project Quit. [2022]
12.United Statespubmed.ncbi.nlm.nih.gov
Benefits of telephone care over primary care for smoking cessation: a randomized trial. [2022]
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