Rural COPD E-Visit Study

March 3, 2026 updated by: Jennifer Dahne, Medical University of South Carolina

Scale and Evaluate Smoking Cessation and COPD Screening E-Visits to Rural Health Clinics

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

More than 16 million Americans have COPD and millions more suffer from COPD but have not yet been diagnosed or treated1. COPD is now concentrated within rural communities and those who reside in rural areas as compared to those who reside in large metropolitan areas have both higher COPD incidence (8% vs. 5%) and higher COPD-related death rates (55 per 100,000 vs. 32 per 100,000)2. Telehealth strategies to implement evidence-based best practice for COPD may be particularly impactful among rural communities as such treatment modalities can extend the reach of traditional COPD prevention, diagnosis, and treatment strategies.

In light of the significant public health impact of COPD, the National Heart Lung, and Blood Institute (NHLBI) issued a COPD National Action Plan in 2017. A key goal within this national action plan is to improve the diagnosis, prevention, treatment, and management of COPD by improving the quality of care delivered across the health care continuum. Because COPD is most commonly caused by cigarette smoking, investigators focus work herein on COPD early detection among cigarette smokers and on leveraging telehealth to extend the reach of evidence-based smoking cessation treatment (i.e., medications and counseling for smoking cessation) for those at risk for COPD. This work will build upon and extend our team's ongoing efforts to develop a smoking cessation electronic visit (e-visit) that can be proactively delivered to all adult MUSC patients who have been identified via the electronic health record as cigarette smokers. E-visits are embedded into the most common electronic health record (EHR) systems (e.g., Epic, Allscripts, and others) and offer a secure platform through which patients can remotely supply providers with health information. Providers in turn can deliver personalized instructions and/or treatment to the patient. Herein, investigators will leverage this proactive, scalable platform to: 1) deliver smoking cessation treatment to adults at risk for COPD and 2) improve rates of COPD early detection and accurate diagnosis. The ultimate goal of this line of work is to improve the quality of care and associated outcomes among patients at risk for COPD. investigators focus specifically on residents of rural areas given considerably higher smoking prevalence in the most rural parts of South Carolina.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
144

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion criteria:

  • Current cigarette smoking, defined as smoking 1+ cigarettes per day, for 20+ days out of the last 30, for the last 6+ months
  • Age 40+
  • Enrolled in Epic's MyChart program or willing to enroll
  • Possess a valid e-mail address that is checked daily to access study assessments and MyChart messages
  • 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™)
  • English fluency

Exclusion criteria:

  • COPD on their problem list within Epic or prior diagnosis of COPD noted elsewhere within the EHR

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Smoking cessation electronic visit (e-visit)
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.
Behavioral: Smoking cessation e-visit
Electronic visits (e-visits) for smoking cessation
Active Comparator: Treatment as usual (TAU)
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.
Behavioral: Treatment as usual
Information about the state quitline and about the importance of quitting smoking and a recommendation to contact one's PCP to schedule a medical visit to discuss quitting smoking.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Smoking Cessation
Time Frame: Month 1
Self-reported smoking via Timeline Follow Back will be biochemically verified via breath CO, with abstinence defined as CO of ≤ 4 ppm. Self-report and CO data will be utilized together to determine 7-day PPA.
Month 1
Smoking Cessation
Time Frame: Month 3
Self-reported smoking via Timeline Follow Back will be biochemically verified via breath CO, with abstinence defined as CO of ≤ 4 ppm. Self-report and CO data will be utilized together to determine 7-day PPA.
Month 3
Smoking Cessation
Time Frame: Month 6
Self-reported smoking via Timeline Follow Back will be biochemically verified via breath CO, with abstinence defined as CO of ≤ 4 ppm. Self-report and CO data will be utilized together to determine 7-day PPA.
Month 6
Reduction in Cigarettes Per Day
Time Frame: Month 1
Reduction in cigarettes per day of 50% via self-report timeline follow back assessment.
Month 1
Reduction in Cigarettes Per Day
Time Frame: Month 3
Reduction in cigarettes per day of 50% via self-report timeline follow back assessment.
Month 3
Reduction in Cigarettes Per Day
Time Frame: Month 6
Reduction in cigarettes per day of 50% via self-report timeline follow back assessment.
Month 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Medical University of South Carolina

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 19, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 24, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 24, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 1, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 5, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 3, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Pro00132325
  • 6 U66RH31458-05-01 (Other Grant/Funding Number: Telehealth Center of Excellence)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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