E-Visit for COPD and Smoking Cessation
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT04155073 |
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Recruitment Status :
Not yet recruiting
First Posted : November 7, 2019
Last Update Posted : November 7, 2019
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Sponsor:
Medical University of South Carolina
Information provided by (Responsible Party):
Jennifer Dahne, Medical University of South Carolina
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Brief 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. 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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Pulmonary Disease, Chronic Obstructive Cigarette Smoking Telemedicine | Behavioral: smoking cessation, early COPD detection, electronic visit Other: Treatment As Usual | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 120 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Health Services Research |
| Official Title: | Development and Testing of an Electronic Visit for COPD Early Detection and Smoking Cessation |
| Estimated Study Start Date : | November 2019 |
| Estimated Primary Completion Date : | September 2020 |
| Estimated Study Completion Date : | September 2020 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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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.
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Behavioral: smoking cessation, early COPD detection, electronic visit
electronic visits (e-visits) for smoking cessation and early detection of chronic obstructive pulmonary disease (COPD) |
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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.
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Other: 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 |
Primary Outcome Measures :
- 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
- Quit attempts [ 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
Secondary Outcome Measures :
- E-visit acceptability and feasibility [ Time Frame: Baseline through Month 3 ]the percentage of patients who complete the initial and follow-up e-visits
Information from the National Library of Medicine
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| Ages Eligible for Study: | 40 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04155073
Contacts
| Contact: Jennifer Dahne, PhD | 843-876-2280 | dahne@musc.edu |
Sponsors and Collaborators
Medical University of South Carolina
| Responsible Party: | Jennifer Dahne, Assistant Professor, Medical University of South Carolina |
| ClinicalTrials.gov Identifier: | NCT04155073 History of Changes |
| Other Study ID Numbers: |
00086016 |
| First Posted: | November 7, 2019 Key Record Dates |
| Last Update Posted: | November 7, 2019 |
| Last Verified: | November 2019 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
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Pulmonary Disease, Chronic Obstructive Lung Diseases Respiratory Tract Diseases Lung Diseases, Obstructive |