Skip to main content
Clinical Trials/NCT05327660
NCT05327660CompletedPhase 1

Remote Carbon Monoxide Monitoring and Incentives for Tobacco Cessation in Quitlines

Consumer Wellness Solutions1 site in 1 country229 target enrollmentStarted: December 31, 2021Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Phase 1
Status
Completed
Sponsor
Enrollment
229
Locations
1
Primary Endpoint
Treatment Satisfaction

Study Overview

Brief Summary

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

Quitline treatment as usual (TAU)

Active Comparator

Quitline services provided by participating state quitlines

Intervention: Quitline Treatment as Usual (TAU) (Combination Product)

Quitline TAU plus remote CO monitoring

Experimental

Quitline service plus daily CO monitoring via a smartphone app

Intervention: Quitline Treatment as Usual (TAU) (Combination Product)

Quitline TAU plus remote CO monitoring

Experimental

Quitline service plus daily CO monitoring via a smartphone app

Intervention: Remote Carbon Monoxide (CO) Monitoring (Combination Product)

Quitline TAU plus incentivized remote CO monitoring

Experimental

Quitline TAU plus remote CO monitoring with small monetary incentives

Intervention: Quitline Treatment as Usual (TAU) (Combination Product)

Quitline TAU plus incentivized remote CO monitoring

Experimental

Quitline TAU plus remote CO monitoring with small monetary incentives

Intervention: Incentivized Remote CO Monitoring (Combination Product)

Outcomes

Primary Outcomes

Treatment Satisfaction

Time Frame: 60 days

Rating of satisfaction with quitline services on a 6-point scale collected via follow-up survey. Five questions were internally developed to determine satisfaction with the quitline services provided where low numbers (1-3) mean dissatisfaction and high numbers (4-6) mean satisfaction. Participants that reported a score of 4 (somewhat satisfied) or more are represented in the data table.

Treatment Engagement

Time Frame: 60 days

Number of quitline calls each participant engages in, collected via clinical record system.

Self-reported Tobacco Abstinence

Time Frame: 60 days

7 day point prevalence abstinence from all combustible tobacco collected via follow-up survey

Secondary Outcomes

  • Biochemically Verified Tobacco Abstinence(60 days)
  • Engagement With CO Monitor(60 days)
  • Satisfaction With CO Monitor(60 days)

Investigators

Sponsor
Consumer Wellness Solutions
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

Loading locations...

Similar Trials