Enhancing Smoking Cessation Via Telehealth Options in Primary Care

NCT ID: NCT05493254

Last Updated: 2025-03-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

672 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-31

Study Completion Date

2026-12-31

Brief Summary

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The purpose of this research study is to evaluate an electronic visit (e-visit) for smoking cessation. 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, motivation to quit, and preferences for medications for quitting smoking. 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.

Detailed Description

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Conditions

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Smoking Cessation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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

Group Type EXPERIMENTAL

Smoking cessation e-visit

Intervention Type BEHAVIORAL

electronic visits (e-visits) for smoking cessation

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.

Group Type ACTIVE_COMPARATOR

Treatment As Usual

Intervention Type BEHAVIORAL

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.

Interventions

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Smoking cessation e-visit

electronic visits (e-visits) for smoking cessation

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

1. current smoking, defined as 1+ cigarettes/day, for 20+ days out of the last 30 for the last 6+ months
2. age 18+
3. enrolled in MyChart or willing to enroll
4. possess a valid e-mail address that is checked daily
5. owner of an iOS or Android smartphone to provide remote CO
6. have a valid mailing address
7. English fluency

Exclusion Criteria

1\) Use of an FDA-approved cessation medication in the last 7 days
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Medical University of South Carolina

OTHER

Sponsor Role lead

Responsible Party

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Jennifer Dahne

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Medical University of South Carolina

Charleston, South Carolina, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Noelle E Natale

Role: CONTACT

843-876-2426

Facility Contacts

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Noelle Natale

Role: primary

843-876-2426

References

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Fahey MC, Wahlquist AE, Diaz VA, Player MS, Natale N, Sterba KR, Chen BK, Hermes EDA, Carpenter MJ, Dahne J. Rationale, design, and protocol for a hybrid type 1 effectiveness-implementation trial of a proactive smoking cessation electronic visit for scalable delivery via primary care: the E-STOP trial. BMC Prim Care. 2023 Nov 29;24(1):254. doi: 10.1186/s12875-023-02205-3.

Reference Type DERIVED
PMID: 38030991 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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R01CA258669

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Pro00113308

Identifier Type: -

Identifier Source: org_study_id

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