Smoking CessationNCT06236347
Rural COPD E-Visit Study
A study testing Smoking cessation e-visit and Treatment as usual in people with Smoking Cessation, run by Medical University of South Carolina at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Smoking cessation e-visit and Treatment as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Mar 2024to Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- COPD on their problem list within Epic or prior diagnosis of COPD noted elsewhere within the EHR
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
Official title: 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.
Read the 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.
- Conditions
- Smoking Cessation
- Being tested
- Smoking cessation e-visit, Treatment as usual
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smoking cessation e-visitBehavioural
Electronic visits (e-visits) for smoking cessation
Treatment as usualBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Smoking cessation electronic visit (e-visit) | Experimental | 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. Receives: Behavioral: Smoking cessation e-visit |
| Treatment as usual (TAU) | Active comparator | 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. Receives: Behavioral: Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Smoking Cessation
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.
Measured: Month 1
Smoking Cessation
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.
Measured: Month 3
Smoking Cessation
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.
Measured: Month 6
Reduction in Cigarettes Per Day
Reduction in cigarettes per day of 50% via self-report timeline follow back assessment.
Measured: Month 1
Reduction in Cigarettes Per Day
Reduction in cigarettes per day of 50% via self-report timeline follow back assessment.
Measured: Month 3
Reduction in Cigarettes Per Day
Reduction in cigarettes per day of 50% via self-report timeline follow back assessment.
Measured: Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2024
- Study start19 Mar 2024
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jennifer Dahne, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06236347
- Sponsor's protocol ID
- Pro00132325
- Other IDs
- 6 U66RH31458-05-01
- Status last verified
- Mar 2026
- First submitted
- 24 Jan 2024
- Last updated
- 5 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Scale and Evaluate Smoking Cessation and COPD Screening E-Visits to Rural Health Clinics
- ClinicalTrials.gov ID
- NCT06236347
- Acronym / sponsor ID
- Pro00132325
- Conditions
- Smoking Cessation
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- 19 Mar 2024 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 1 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Smoking cessation electronic visit (e-visit) | Experimental | Behavioral: Smoking cessation e-visitThis 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. |
| Treatment as usual (TAU) | Active comparator | Behavioral: Treatment as usualThis 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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (1 listed)
- COPD on their problem list within Epic or prior diagnosis of COPD noted elsewhere within the EHR
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smoking cessation e-visitElectronic visits (e-visits) for smoking cessation | Behavioural | Smoking cessation electronic visit (e-visit) |
| Treatment as usualInformation 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. | Behavioural | Treatment as usual (TAU) |
Primary outcome
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.
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.
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.
Reduction in Cigarettes Per Day
Time frame: Month 1
Reduction in cigarettes per day of 50% via self-report timeline follow back assessment.
Reduction in Cigarettes Per Day
Time frame: Month 3
Reduction in cigarettes per day of 50% via self-report timeline follow back assessment.
Reduction in Cigarettes Per Day
Time frame: Month 6
Reduction in cigarettes per day of 50% via self-report timeline follow back assessment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smoking cessation e-visit and Treatment as usual in people with Smoking Cessation, run by Medical University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Smoking Cessation (time frame: Month 1). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2026.