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

NCT ID: NCT05145738

Last Updated: 2025-12-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-23
• Study Completion Date: 2022-09-15

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.

Conditions

Tobacco Smoking

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

C-Raven + Avatar

Computer delivered intervention with Avatar as virtual counselor plus linkage to community health worker

Group Type: EXPERIMENTAL

C-Raven with avatar

Intervention Type: BEHAVIORAL

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

C-Raven

Computer-delivered intervention without virtual counselor, with linkage to community health worker

Group Type: ACTIVE_COMPARATOR

C-Raven without avatar

Intervention Type: BEHAVIORAL

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

Interventions

C-Raven with avatar

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

Intervention Type: BEHAVIORAL

C-Raven without avatar

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Geetanjali Chander

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Johns Hopkins Tobacco Treatment Clinic at Johns Hopkins Bayview Medical Center

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

IRB00300496

Identifier Type: -

Identifier Source: org_study_id