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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05145738
Other study ID # IRB00300496
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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)

Study Design


Related Conditions & MeSH terms


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
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