Pulmonary Disease, Chronic ObstructiveNCT04155073
E-Visit for COPD and Smoking Cessation
A study testing smoking cessation, early COPD detection, electronic visit and Treatment As Usual in people with Pulmonary Disease, Chronic Obstructive and Cigarette Smoking, run by Medical University of South Carolina at 1 site in United States.
Trial summary
The goal of this work is to develop, refine, and pilot test an electronic visit (e-visit) to: 1) deliver smoking cessation treatment to adults at risk for COPD and 2) to improve rates of COPD early detection and accurate diagnosis. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive, Cigarette Smoking, Telemedicine
- What is being tested?
- smoking cessation, early COPD detection, electronic 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
- 125 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Dec 2019to 12 Mar 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- current cigarette smoker,
- enrolled in MUSC's Epic MyChart program or willing to sign up for MyChart,
- possess a valid e-mail address that is checked daily,
- English fluency, and
- owner of an iOS or Android-compatible smartphone and a webcam-enabled device
Who cannot join
- COPD on a patient's problem list within Epic.
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
Official title: Development and Testing of an Electronic Visit for COPD Early Detection and Smoking Cessation
The goal of this work is to develop, refine, and pilot test an electronic visit (e-visit) to: 1) deliver smoking cessation treatment to adults at risk for COPD and 2) to improve rates of COPD early detection and accurate diagnosis. The investigators will conduct a pilot RCT of the COPD/smoking cessation e-visit as compared to treatment as usual (TAU), with primary objective to provide effect size estimates for a larger RCT.
- Being tested
- smoking cessation, early COPD detection, electronic visit, Treatment As Usual
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Cigarette Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
smoking cessation, early COPD detection, electronic visitBehavioural
electronic visits (e-visits) for smoking cessation and early detection of chronic obstructive pulmonary disease (COPD)
Treatment As UsualOther
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 |
|---|---|---|
| COPD/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, quitting smoking, and respiratory symptoms, 2) an invitation to complete a follow-up e-visit one-month after the initial e-visit, and if needed, 3) a home spirometry test with instructions on how to video themselves completing a lung functioning test via the device within an additional e-visit. Receives: Behavioral: smoking cessation, early COPD detection, electronic 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: Other: Treatment As Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evidence-based Cessation Treatment Utilization
participants in both groups will be queried for use of a smoking cessation medication since the last assessment
Measured: Baseline through Month 3
Number of Participants at Month 1 and Month 3 With At Least 1 Quit Attempt
quit attempts will be assessed at each follow-up using a timeline followback for the last 6-months at baseline and since prior follow-up for each subsequent assessment
Measured: Baseline through Month 3
Secondary outcomes (1)
E-visit Acceptability and Feasibility
the percentage of patients who complete the initial and follow-up e-visits
Measured: Baseline through Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2019
- Study start12 Dec 2019
- Primary completion12 Mar 2021
- Study completion12 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies 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
- 125 participants (actual)
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
- NCT04155073
- Sponsor's protocol ID
- 00086016
- Status last verified
- Jul 2023
- First submitted
- 1 Nov 2019
- Last updated
- 21 Feb 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Dahne J, Player MS, Strange C, Carpenter MJ, Ford DW, King K, Miller S, Kruis R, Hawes E, Hidalgo JE, Diaz VA. Proactive Electronic Visits for Smoking Cessation and Chronic Obstructive Pulmonary Disease Screening in Primary Care: Randomized Controlled Trial of Feasibility, Acceptability, and Efficacy. J Med Internet Res. 2022 Aug 30;24(8):e38663. doi: 10.2196/38663.
PubMed 36040766
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Testing of an Electronic Visit for COPD Early Detection and Smoking Cessation
- ClinicalTrials.gov ID
- NCT04155073
- Acronym / sponsor ID
- 00086016
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- 12 Dec 2019 (actual)
- Primary completion
- 12 Mar 2021 (actual)
- Study completion
- 12 Mar 2021 (actual)
- First posted
- 7 Nov 2019 (actual)
- Results
- Posted 21 Feb 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this work is to develop, refine, and pilot test an electronic visit (e-visit) to: 1) deliver smoking cessation treatment to adults at risk for COPD and 2) to improve rates of COPD early detection and accurate diagnosis. The investigators will conduct a pilot RCT of the COPD/smoking cessation e-visit as compared to treatment as usual (TAU), with primary objective to provide effect size estimates for a larger RCT.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COPD/smoking cessation electronic visit (e-visit) | Experimental | Behavioral: smoking cessation, early COPD detection, electronic visitThis group will be sent 1) an invitation to complete an electronic visit (e-visit) focused on cigarette smoking, quitting smoking, and respiratory symptoms, 2) an invitation to complete a follow-up e-visit one-month after the initial e-visit, and if needed, 3) a home spirometry test with instructions on how to video themselves completing a lung functioning test via the device within an additional e-visit. |
| Treatment as Usual (TAU) | Active comparator | Other: 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
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- current cigarette smoker,
- enrolled in MUSC's Epic MyChart program or willing to sign up for MyChart,
- possess a valid e-mail address that is checked daily,
- English fluency, and
- owner of an iOS or Android-compatible smartphone and a webcam-enabled device
Key exclusion criteria (1 listed)
- COPD on a patient's problem list within Epic.
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, early COPD detection, electronic visitelectronic visits (e-visits) for smoking cessation and early detection of chronic obstructive pulmonary disease (COPD) | Behavioural | COPD/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 | Other | Treatment as Usual (TAU) |
Primary outcome
Evidence-based Cessation Treatment Utilization
Time frame: Baseline through Month 3
participants in both groups will be queried for use of a smoking cessation medication since the last assessment
Number of Participants at Month 1 and Month 3 With At Least 1 Quit Attempt
Time frame: Baseline through Month 3
quit attempts will be assessed at each follow-up using a timeline followback for the last 6-months at baseline and since prior follow-up for each subsequent assessment
1 secondary outcome
E-visit Acceptability and Feasibility
Time frame: Baseline through Month 3
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36040766Dahne J, Player MS, Strange C, Carpenter MJ, Ford DW, King K, Miller S, Kruis R, Hawes E, Hidalgo JE, Diaz VA. Proactive Electronic Visits for Smoking Cessation and Chronic Obstructive Pulmonary Disease Screening in Primary Care: Randomized Controlled Trial of Feasibility, Acceptability, and Efficacy. J Med Internet Res. 2022 Aug 30;24(8):e38663. doi: 10.2196/38663.
Related trials for Pulmonary Disease, Chronic Obstructive
Recruiting
Rehabilitation in Safety-net Environments (RISE) to Improve Outcomes in Vulnerable Patients With COPD
COPD (Chronic Obstructive Pulmonary Disease)
RecruitingObservational study
Characteristics and Outcomes of Patients Admitted to ICU for a Severe Acute Exacerbation of COPD.
COPD Exacerbation, ICU
Active, not recruitingPhase 1
Comparison of Bronchodilator Response From Three Different Aerosol Delivery Methods in Patients With COPD Using Hyperpolarized Xe 129 MRI Ventilation Imaging
Chronic Obstructive Pulmonary Disease
RecruitingPhase 4
Genetic Variation in IgG in Alpha 1 Antitrypsin Deficiency
Alpha 1-Antitrypsin, COPD
RecruitingPhase 2
Rademikibart IV for Acute Asthma and COPD Exacerbation
Asthma Acute, COPD Exacerbation Acute
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. This study is not recruiting at the moment.
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, early COPD detection, electronic visit and Treatment As Usual in people with Pulmonary Disease, Chronic Obstructive and Cigarette Smoking, 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 5 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: finished, as of the sponsor's last update on 21 Feb 2024. 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?
Yes. Results are posted in the registry (first posted 21 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Evidence-based Cessation Treatment Utilization (time frame: Baseline through Month 3). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04155073, which also lists 1 linked publication.
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 21 Feb 2024; AzTrials last refreshed its copy on 28 Oct 2026.