CO Monitoring for Tobacco Cessation in Quitlines

NCT ID: NCT05327660

Last Updated: 2024-10-28

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

229 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-31

Study Completion Date

2022-11-01

Brief Summary

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The present study is a 3-arm randomized controlled pilot study. Participants who call the Maryland Tobacco Quitline and are eligible for study participation are randomized to receive quitline tobacco cessation treatment as usual (TAU), TAU plus remote carbon monoxide (CO) monitoring via smartphone app, or TAU plus remote carbon monoxide monitoring plus incentives vis smartphone app. The investigators hypothesize that remote CO monitoring will be feasible and acceptable to deliver in the quitline setting, will increase treatment engagement, and will increase tobacco cessation and treatment satisfaction rates.

Detailed Description

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Conditions

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Tobacco Dependence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Quitline treatment as usual (TAU)

Quitline services provided by participating state quitlines

Group Type ACTIVE_COMPARATOR

Quitline Treatment as Usual (TAU)

Intervention Type COMBINATION_PRODUCT

Quitline TAU is services provided by the state quitline and includes phone coaching, nicotine replacement, supplemental materials (e.g., text messaging, online content).

Quitline TAU plus remote CO monitoring

Quitline service plus daily CO monitoring via a smartphone app

Group Type EXPERIMENTAL

Quitline Treatment as Usual (TAU)

Intervention Type COMBINATION_PRODUCT

Quitline TAU is services provided by the state quitline and includes phone coaching, nicotine replacement, supplemental materials (e.g., text messaging, online content).

Remote Carbon Monoxide (CO) Monitoring

Intervention Type COMBINATION_PRODUCT

Remote CO monitoring includes a smartphone app and a remote carbon monoxide monitor. The app tracks and prompts daily use of the CO monitor.

Quitline TAU plus incentivized remote CO monitoring

Quitline TAU plus remote CO monitoring with small monetary incentives

Group Type EXPERIMENTAL

Quitline Treatment as Usual (TAU)

Intervention Type COMBINATION_PRODUCT

Quitline TAU is services provided by the state quitline and includes phone coaching, nicotine replacement, supplemental materials (e.g., text messaging, online content).

Incentivized Remote CO Monitoring

Intervention Type COMBINATION_PRODUCT

Incentivized remote CO monitoring includes a smartphone app and a remote carbon monoxide monitor. The app tracks and prompts daily use of the CO monitor and delivers small monetary incentives for each use of the CO monitor.

Interventions

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Quitline Treatment as Usual (TAU)

Quitline TAU is services provided by the state quitline and includes phone coaching, nicotine replacement, supplemental materials (e.g., text messaging, online content).

Intervention Type COMBINATION_PRODUCT

Remote Carbon Monoxide (CO) Monitoring

Remote CO monitoring includes a smartphone app and a remote carbon monoxide monitor. The app tracks and prompts daily use of the CO monitor.

Intervention Type COMBINATION_PRODUCT

Incentivized Remote CO Monitoring

Incentivized remote CO monitoring includes a smartphone app and a remote carbon monoxide monitor. The app tracks and prompts daily use of the CO monitor and delivers small monetary incentives for each use of the CO monitor.

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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Inclusion Criteria

* Daily cigarette smokers calling into participating quitlines
* 18 year or older
* Reads and speaks English
* Has a smartphone with a data plan
* Willing to download and use study app
* Willing to use CO monitor

Exclusion Criteria

• Pregnant or breast feeding
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Vincere Health

INDUSTRY

Sponsor Role collaborator

Maryland State Tobacco Quitline

OTHER

Sponsor Role collaborator

Consumer Wellness Solutions

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kelly Carpenter, PhD

Role: PRINCIPAL_INVESTIGATOR

Consumer Wellness Solutions

Locations

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Optum Center for Wellbeing Research

Seattle, Washington, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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2021-0056

Identifier Type: -

Identifier Source: org_study_id

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