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E-Visit for COPD and Smoking Cessation

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ClinicalTrials.gov Identifier: NCT04155073
Recruitment Status : Not yet recruiting
First Posted : November 7, 2019
Last Update Posted : November 7, 2019
Sponsor:
Information provided by (Responsible Party):
Jennifer Dahne, Medical University of South Carolina

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

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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
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.
Behavioral: smoking cessation, early COPD detection, electronic 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.
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 :
  1. 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

  2. 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 :
  1. E-visit acceptability and feasibility [ Time Frame: Baseline through Month 3 ]
    the percentage of patients who complete the initial and follow-up e-visits



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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
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Contact: Jennifer Dahne, PhD 843-876-2280 dahne@musc.edu

Sponsors and Collaborators
Medical University of South Carolina

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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

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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