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

NCT05145738 | Completed

• 1 other identifier: IRB00300496
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Percent of persons agreeing to participate among those referred

  Feasibility will be assessed with percent of persons agreeing to participate among those referred.

  3 months

• Percent of contacts made with community health worker

  Implementation will be assessed with percent of contacts made with community health worker.

  3 months

Secondary Outcomes (3)

• Readiness to quit smoking as assessed by a visual analog scale

  Immediately post intervention

• Uptake of pharmacotherapy as assessed by a yes/no response

  3 months

• Smoking cessation as assessed by 7-day no tobacco use self report

  3 months

Study Arms (2)

C-Raven + Avatar

EXPERIMENTAL

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

Behavioral: C-Raven with avatar

C-Raven

ACTIVE COMPARATOR

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

Behavioral: C-Raven without avatar

Interventions

C-Raven with avatar BEHAVIORAL

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

C-Raven + Avatar

C-Raven without avatar BEHAVIORAL

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

C-Raven

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins Tobacco Treatment Clinic at Johns Hopkins Bayview Medical Center

Baltimore, Maryland, 21224, United States

Location

MeSH Terms

Conditions

Tobacco Smoking

Condition Hierarchy (Ancestors)

Smoking; Behavior; Tobacco Use

Study Officials

• Geetanjali Chander

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Care providers, investigators and outcome assessors will be blind to avatar versus no avatar conditions
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2021
• First Posted: December 6, 2021
• Study Start: December 23, 2021
• Primary Completion: September 15, 2022
• Study Completion: September 15, 2022
• Last Updated: December 1, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)