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Pilot Testing a Computer Delivered Tobacco Cessation Intervention in Outpatient Clinical Settings: A Feasibility Study

Pilot Testing a Computer Delivered Tobacco Cessation Intervention in Outpatient Clinical Settings: A Feasibility Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05145738
Enrollment
18
Registered
2021-12-06
Start date
2021-12-23
Completion date
2022-09-15
Last updated
2025-12-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tobacco Smoking

Brief summary

The investigators have developed a hybrid computer- and person-delivered intervention, called C-Raven for smoking cessation that is tailored to people with tobacco use in Baltimore City. The computer delivered component consists of two \ 20 minute sessions on an iPad guided by Edna Poe, an interactive avatar. These sessions are followed by elective in vivo initiation of nicotine replacement therapy (NRT). Community health workers (CHWs) trained in smoking cessation and motivational interviewing provide 6 weeks of supportive follow up counseling. The investigators propose a pilot of the intervention package in the Tobacco Treatment and Lung Cancer Screening Clinic (TTLCSC) at Johns Hopkins Hospital, and the Johns Hopkins Broadway Center for Addiction, assessing feasibility and acceptability of using this tool in these clinical settings. In addition, the investigators will compare whether the use of a virtual counselor is associated with greater satisfaction and engagement with the program. To this end, the investigators propose a two-arm randomized controlled trial, randomizing up to 90 individuals with tobacco use to the current CRAVEN program which includes a virtual counselor, to CRAVEN without a virtual counselor. Primary outcomes include intervention feasibility and acceptability. The investigators will secondarily examine uptake and maintenance of pharmacotherapy for tobacco cessation, readiness to quit smoking, and tobacco cessation (7 day abstinence) at 6 months, patient satisfaction by intervention arm and CHW engagement by intervention arm.

Interventions

BEHAVIORALC-Raven with avatar

Computer delivered intervention with the investigators' avatar; with linkage to community health worker.

BEHAVIORALC-Raven without avatar

Computer delivered intervention without the investigators' avatar; with linkage to community health worker.

Sponsors

Johns Hopkins University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)

Masking description

Care providers, investigators and outcome assessors will be blind to avatar versus no avatar conditions

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Adults ≥18 years of age receiving care in one of the two specified clinics * Current daily smoker and has smoked \>100 cigarettes in their lifetime * English speaking * Cognitively able to understand proposed research design

Exclusion criteria

* Actively psychotic or other severe mental health symptoms * Any contraindication to NRT use * Hearing impaired (unable to listen to audio component of intervention)

Design outcomes

Primary

MeasureTime frameDescription
Percent of persons agreeing to participate among those referred3 monthsFeasibility will be assessed with percent of persons agreeing to participate among those referred.
Percent of contacts made with community health worker3 monthsImplementation will be assessed with percent of contacts made with community health worker.

Secondary

MeasureTime frameDescription
Readiness to quit smoking as assessed by a visual analog scaleImmediately post interventionA visual analog scale of 0-100 with 0 indicating not ready to change and 100 indicating ready to change.
Uptake of pharmacotherapy as assessed by a yes/no response3 monthsAny uptake of nicotine replacement therapy or varenicline or wellbutrin. Dichotomous yes/no response will be collected.
Smoking cessation as assessed by 7-day no tobacco use self report3 months7 day point prevalence abstinence. No tobacco use for 7 days by self report - yes/no.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026