NCT04155073

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
125

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 1, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 7, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

December 12, 2019

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 12, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 12, 2021

Completed
2.9 years until next milestone

Results Posted

Study results publicly available

February 21, 2024

Completed
Last Updated

February 21, 2024

Status Verified

July 1, 2023

Enrollment Period

1.2 years

First QC Date

November 1, 2019

Results QC Date

July 1, 2022

Last Update Submit

July 21, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • Evidence-based Cessation Treatment Utilization

    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

    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 Outcomes (1)

  • E-visit Acceptability and Feasibility

    Baseline through Month 3

Study Arms (2)

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.

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.

Other: Treatment As Usual

Interventions

electronic visits (e-visits) for smoking cessation and early detection of chronic obstructive pulmonary disease (COPD)

COPD/smoking cessation electronic visit (e-visit)

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

Treatment as Usual (TAU)

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • COPD on a patient's problem list within Epic.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveCigarette Smoking

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsTobacco SmokingSmokingBehaviorTobacco Use

Results Point of Contact

Title
Dr. Jennifer Dahne
Organization
Medical University of South Carolina

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

November 1, 2019

First Posted

November 7, 2019

Study Start

December 12, 2019

Primary Completion

March 12, 2021

Study Completion

March 12, 2021

Last Updated

February 21, 2024

Results First Posted

February 21, 2024

Record last verified: 2023-07

Locations