CO Monitoring for Tobacco Cessation in Quitlines

Consumer Wellness Solutions

Status and phase: Completed; Phase 2; Phase 1

Conditions: Tobacco Dependence

Treatments: Combination Product: Remote Carbon Monoxide (CO) Monitoring; Combination Product: Quitline Treatment as Usual (TAU); Combination Product: Incentivized Remote CO Monitoring

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT05327660

2021-0056

Details and patient eligibility

About

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.

Enrollment: 229 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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229 participants in 3 patient groups

Quitline treatment as usual (TAU)

Active Comparator group

Description:

Quitline services provided by participating state quitlines

Treatment:

Combination Product: Quitline Treatment as Usual (TAU)

Quitline TAU plus remote CO monitoring

Experimental group

Description:

Quitline service plus daily CO monitoring via a smartphone app

Treatment:

Combination Product: Quitline Treatment as Usual (TAU)

Combination Product: Remote Carbon Monoxide (CO) Monitoring

Quitline TAU plus incentivized remote CO monitoring

Experimental group

Description:

Quitline TAU plus remote CO monitoring with small monetary incentives

Treatment:

Combination Product: Incentivized Remote CO Monitoring

Combination Product: Quitline Treatment as Usual (TAU)