- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04155073
E-Visit for COPD and Smoking Cessation
July 21, 2023 updated by: Jennifer Dahne, Medical University of South Carolina
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
125
Phase
- 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
-
-
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
Ages Eligible for Study
40 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- COPD on a patient's problem list within Epic.
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 |
Intervention / Treatment |
|---|---|
|
Experimental: COPD/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, 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.
|
electronic visits (e-visits) for smoking cessation and early detection of chronic obstructive pulmonary disease (COPD)
|
|
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.
|
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
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
Baseline through Month 3
|
|
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
|
Baseline through Month 3
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
E-visit Acceptability and Feasibility
Time Frame: Baseline through Month 3
|
the percentage of patients who complete the initial and follow-up e-visits
|
Baseline through Month 3
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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)
December 12, 2019
Primary Completion (Actual)
March 12, 2021
Study Completion (Actual)
March 12, 2021
Study Registration Dates
First Submitted
November 1, 2019
First Submitted That Met QC Criteria
November 4, 2019
First Posted (Actual)
November 7, 2019
Study Record Updates
Last Update Posted (Estimated)
February 21, 2024
Last Update Submitted That Met QC Criteria
July 21, 2023
Last Verified
July 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 00086016
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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