Pilot Testing a Computer Delivered Tobacco Cessation Intervention in Outpatient Clinical Settings: A Feasibility Study
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Maryland
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Baltimore, Maryland, United States, 21224
- Johns Hopkins Tobacco Treatment Clinic at Johns Hopkins Bayview Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: C-Raven + Avatar
Computer delivered intervention with Avatar as virtual counselor plus linkage to community health worker
|
Computer delivered intervention with the investigators' avatar; with linkage to community health worker.
|
|
Active Comparator: C-Raven
Computer-delivered intervention without virtual counselor, with linkage to community health worker
|
Computer delivered intervention without the investigators' avatar; with linkage to community health worker.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Percent of persons agreeing to participate among those referred
Time Frame: 3 months
|
Feasibility will be assessed with percent of persons agreeing to participate among those referred.
|
3 months
|
|
Percent of contacts made with community health worker
Time Frame: 3 months
|
Implementation will be assessed with percent of contacts made with community health worker.
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Readiness to quit smoking as assessed by a visual analog scale
Time Frame: Immediately post intervention
|
A visual analog scale of 0-100 with 0 indicating not ready to change and 100 indicating ready to change.
|
Immediately post intervention
|
|
Uptake of pharmacotherapy as assessed by a yes/no response
Time Frame: 3 months
|
Any uptake of nicotine replacement therapy or varenicline or wellbutrin.
Dichotomous yes/no response will be collected.
|
3 months
|
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Smoking cessation as assessed by 7-day no tobacco use self report
Time Frame: 3 months
|
7 day point prevalence abstinence.
No tobacco use for 7 days by self report - yes/no.
|
3 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Geetanjali Chander, Johns Hopkins University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00300496
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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