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

Tobacco Smoking Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05145738
• Other study ID #: IRB00300496
• Status: Completed
• Phase: N/A
• Start date: December 23, 2021
• Est. completion date: September 15, 2022

Study information

• Verified date: July 2023
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: September 15, 2022
• Est. primary completion date: September 15, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Tobacco Smoking

Intervention

Behavioral:
• C-Raven with avatar
Computer delivered intervention with the investigators' avatar; with linkage to community health worker.
• C-Raven without avatar
Computer delivered intervention without the investigators' avatar; with linkage to community health worker.

Locations

Country	Name	City	State
United States	Johns Hopkins Tobacco Treatment Clinic at Johns Hopkins Bayview Medical Center	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Percent of contacts made with community health worker	Implementation will be assessed with percent of contacts made with community health worker.	3 months
Secondary	Readiness to quit smoking as assessed by a visual analog scale	A visual analog scale of 0-100 with 0 indicating not ready to change and 100 indicating ready to change.	Immediately post intervention
Secondary	Uptake of pharmacotherapy as assessed by a yes/no response	Any uptake of nicotine replacement therapy or varenicline or wellbutrin. Dichotomous yes/no response will be collected.	3 months
Secondary	Smoking cessation as assessed by 7-day no tobacco use self report	7 day point prevalence abstinence. No tobacco use for 7 days by self report - yes/no.	3 months