NCT06236347

Brief Summary

The purpose of this study is to evaluate an electronic visit (e-visit) for COPD screening and for quitting smoking. Participants will be randomly assigned to receive either the smoking cessation e-visit or not. The e-visit will look similar to an online questionnaire asking about smoking history, preferences for cessation medications, and chronic COPD symptoms. Participants may receive a prescription for a smoking cessation medication as an outcome of the e-visit, if randomized to the e-visit group, but there is no requirement to take any medication. This study consists of questionnaires and breath samples provided at 4 separate time points throughout the study. Participation in this study will take about 24 weeks.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
144

participants targeted

Target at P75+ for not_applicable

Timeline
8mo left

Started Mar 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

Study Progress76%
Mar 2024Feb 2027

First Submitted

Initial submission to the registry

January 24, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 1, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

March 19, 2024

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2027

Last Updated

March 5, 2026

Status Verified

March 1, 2026

Enrollment Period

2.9 years

First QC Date

January 24, 2024

Last Update Submit

March 3, 2026

Conditions

Smoking Cessation

Outcome Measures

Primary Outcomes (6)

  • Smoking Cessation

    Self-reported smoking via Timeline Follow Back will be biochemically verified via breath CO, with abstinence defined as CO of ≤ 4 ppm. Self-report and CO data will be utilized together to determine 7-day PPA.

    Month 1

  • Smoking Cessation

    Self-reported smoking via Timeline Follow Back will be biochemically verified via breath CO, with abstinence defined as CO of ≤ 4 ppm. Self-report and CO data will be utilized together to determine 7-day PPA.

    Month 3

  • Smoking Cessation

    Self-reported smoking via Timeline Follow Back will be biochemically verified via breath CO, with abstinence defined as CO of ≤ 4 ppm. Self-report and CO data will be utilized together to determine 7-day PPA.

    Month 6

  • Reduction in Cigarettes Per Day

    Reduction in cigarettes per day of 50% via self-report timeline follow back assessment.

    Month 1

  • Reduction in Cigarettes Per Day

    Reduction in cigarettes per day of 50% via self-report timeline follow back assessment.

    Month 3

  • Reduction in Cigarettes Per Day

    Reduction in cigarettes per day of 50% via self-report timeline follow back assessment.

    Month 6

Study Arms (2)

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 and 2) an invitation to complete a follow-up e-visit one-month after the initial e-visit.

Behavioral: Smoking cessation e-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.

Behavioral: Treatment as usual

Interventions

Smoking cessation e-visitBEHAVIORAL

Electronic visits (e-visits) for smoking cessation

Smoking cessation electronic visit (e-visit)
Treatment as usualBEHAVIORAL

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 VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Current cigarette smoking, defined as smoking 1+ cigarettes per day, for 20+ days out of the last 30, for the last 6+ months
  • Age 40+
  • Enrolled in Epic's MyChart program or willing to enroll
  • Possess a valid e-mail address that is checked daily to access study assessments and MyChart messages
  • Owner of an iOS or Android compatible smartphone to provide remote CO readings
  • Have a valid address at which mail can be received (for mailing iCO™)
  • English fluency

You may not qualify if:

  • COPD on their problem list within Epic or prior diagnosis of COPD noted elsewhere within the EHR

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Smoking Cessation

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

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
Associate Professor - Faculty

Study Record Dates

First Submitted

January 24, 2024

First Posted

February 1, 2024

Study Start

March 19, 2024

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

February 1, 2027

Last Updated

March 5, 2026

Record last verified: 2026-03

Locations

US(1)