Trial Title:
C-Raven, a Virtual Tobacco Cessation Intervention in the Community
NCT ID:
NCT06545669
Condition:
Tobacco Dependence
Conditions: Official terms:
Tobacco Use Disorder
Nicotine
Study type:
Interventional
Study phase:
Phase 4
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Eligible participants are randomly assigned to intervention or no intervention. Outcomes
for those who receive the intervention will be compared to outcomes for those who do not
receive the intervention. Those who do not receive the intervention during the initial
study period will receive it at the end, to ensure access to treatment for all
participants.
Primary purpose:
Treatment
Masking:
None (Open Label)
Masking description:
The statistical analyst will not be made aware of which treatment group received the
intervention.
Intervention:
Intervention type:
Behavioral
Intervention name:
C-Raven Virtual Tobacco Cessation Counseling
Description:
A two-module tobacco cessation intervention that involves interaction with a virtual
counselor and includes instruction about addiction and the use of pharmacotherapy for
cessation. Each module takes approximately 20 minutes to complete.
Arm group label:
C-Raven + CHW Smoking Cessation Intervention
Intervention type:
Drug
Intervention name:
Nicotine Replacement Product
Description:
Participants will be offered a 12-week supply of nicotine patches and either nicotine gum
or lozenges.
Arm group label:
C-Raven + CHW Smoking Cessation Intervention
Intervention type:
Other
Intervention name:
Community Health Worker
Description:
A community health worker will meet with each participant throughout the study period to
teach appropriate NRT usage, discuss barriers/facilitators to NRT use and cessation,
conduct shared decision-making about lung cancer screening, and provide health system
navigation when needed.
Arm group label:
C-Raven + CHW Smoking Cessation Intervention
Intervention type:
Other
Intervention name:
Lung Cancer Screening
Description:
After participating in shared decision-making, eligible participants will be referred to
their primary care physician or existing specialist to complete lung cancer screening.
Arm group label:
C-Raven + CHW Smoking Cessation Intervention
Summary:
In low-income housing units in Baltimore, the investigators propose to conduct a pilot
two-arm hybrid type 1 effectiveness-implementation RCT comparing a) an avatar-delivered
computerized intervention (CI) for tobacco cessation augmented with CHW support and
navigation to lung cancer screening to b) a waitlist control.
With a sample of participants from public housing units (N=30), the investigators will
collect data on feasibility of recruitment, intervention engagement and completion, and
short-term smoking cessation outcomes. Individuals will be assessed at baseline, 1 month,
3 months, and 6 months. At the 3-month time point, the investigators will conduct
interviews with a subset of pilot participants to collect qualitative data on
intervention acceptability.
Detailed description:
The investigators will conduct a pilot randomized controlled trial of an avatar-delivered
computerized intervention for tobacco cessation and CHW support to collect data on the
feasibility of recruitment, intervention engagement and completion, and short-term
smoking cessation outcomes. Individuals will be assessed at baseline, one month, three
months, and six months. At the end of three months, the investigators will conduct
follow-up interviews with a subset of pilot participants to collect qualitative data on
intervention acceptability. Based on the information collected in these efforts, the
investigators will make iterative improvements to the existing intervention, aligned with
user-experience design procedures.
Participants (N=30) will be recruited through flyers posted in and around the housing
units and distributed to tenants by housing unit staff. Flyers will describe the study
and contain a study phone number to call. Information may also be distributed by study
staff during non-study-related health and wellness activities conducted at the sites. At
initial contact, a study staff member will discuss the study purpose and determine
eligibility. If eligible, the staff member will proceed to discuss requirements, review
risks and benefits, and obtain informed consent from interested participants.
Consent process: After confirming eligibility with screening questions via phone,
potential participants will be offered the option of reviewing the study information and
consent form over a Zoom video conference. Regardless of whether the participants choose
to review this information in advance, all potential participants will complete the
consent process and sign the consent form at the beginning of the first in-person visit,
which will be conducted on-site at the participants housing community.
Randomization: Following consent, participants will be randomized to the intervention
group or a control group. The control group will not receive any intervention during the
first 6 months of the study, but at the end of 6 months will receive the full computer
intervention and abbreviated CHW support to ensure access to treatment for all
participants.
Baseline Assessment: This will occur on the same day as the in-person portion of the
consent process. Initial evaluation will comprise a number of questionnaires/assessments,
including demographics, a clinical history, a tobacco use history, and a number of
tobacco-related measures. Assessments will be self-administered via tablet computer.
Intervention:
Computer-Delivered Intervention (CDI) Session 1: Following the baseline assessment,
participants will receive computer-delivered counseling via a study-provided iPad
delivered in a private room. The CDI consists of 1) a menu-driven, web-based intervention
that is delivered by a virtual counselor. The intervention takes 20 minutes to complete.
At the conclusion of session 1, the participant will be offered nicotine patches provided
by the study (1 month supply, remainder given at follow-up visits). The initial dosing of
the nicotine patches will be determined based on cigarettes consumed per day (>10: 21mg
patch, 5-10: 14mg patch, <5: 7mg patch). If there is any question regarding eligibility
or appropriate dosing, the CHW will consult with a study physician. With the CHW, the
participant will learn correct application, and will monitor the participants nicotine
replacement therapy (NRT) experience in discussion with the CHW.
Computer-Delivered Intervention (CDI) Session 2: Session 2, delivered approximately one
week later, focuses on the cycle of addiction and use of pharmacotherapy (e.g., NRT,
bupropion, varenicline). This intervention also takes about 20 minutes to complete. At
the conclusion of session 2, the participant will be offered nicotine gum or lozenges
provided by the study (1 month supply, remainder given at follow-up visits). This session
also includes an in-session experience of using NRT gum or lozenge, with CHW guidance to
ensure correct use.
Community Health Workers (CHWs): A CHW will meet with each participant for both Sessions
1 and 2 and will do the following: 1) Teach appropriate NRT use technique as above, 2)
Follow up with patients remotely via phone or video conference whenever possible, up to
twice weekly for 12 weeks (4 weeks for control group receiving delayed intervention), to
discuss barriers/facilitators to maintenance of NRT use and tobacco cessation; 3) Review
a video and decision-making guide for lung cancer screening and provide linkage to lung
cancer screening if the participant is eligible and interested, including linkage to
insurance enrollment assistance, if needed; 4) For individuals requiring follow up for
positive findings on lung CT, work with participants to navigate the process; 5) Link
interested participants to the QuitLine; 6) At the end of the study, link to medical
providers for additional tobacco cessation therapy if participant interested (e.g.,
varenicline, bupropion).
Linkage to Lung Cancer Screening: Participants eligible for and interested in CT Lung
cancer screening (age ≥50, ≥20 pack year smoking history) will be referred to the
participants primary care physician (PCP) or existing specialist for further discussion
and ordering. The CTs are optional and will not be provided as part of the research
study. The CHW will assist with linking patients without a PCP or existing specialist
with resources to establish care. For participants who choose to proceed with screening,
the investigators will request the results of the CT scan to track completion and general
result category (Normal/Normal with Minor Findings/Abnormal Needing Short-Term
Follow-Up/Abnormal Needing Immediate Follow-Up).
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Age 50 or older Current tobacco use with >100 cigarettes smoked in their lifetime
- English speaking (intervention currently in English only and housing units are in
largely English-speaking neighborhoods)
- Considering smoking cessation
- Planning to remain in current housing unit for 9 months
Exclusion Criteria:
- Current use of pharmacological treatment for tobacco cessation
- Contraindication to nicotine replacement therapy
- Current engagement in formal smoking cessation program
- Major cognitive or psychiatric impairment
- Severe hearing impairment
- Investigator discretion
Gender:
All
Minimum age:
50 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Johns Hopkins University School of Medicine
Address:
City:
Baltimore
Zip:
21205
Country:
United States
Status:
Recruiting
Contact:
Last name:
Alejandra Ellison-Barnes, MD
Phone:
410-614-1135
Email:
aelliso6@jhmi.edu
Contact backup:
Last name:
Heidi Hutton
Phone:
(443) 287-2874
Email:
hhutton@jhmi.edu
Start date:
October 30, 2024
Completion date:
June 2025
Lead sponsor:
Agency:
Johns Hopkins University
Agency class:
Other
Collaborator:
Agency:
Maryland Cigarette Restitution Fund
Agency class:
Other
Collaborator:
Agency:
Walgreens
Agency class:
Other
Source:
Johns Hopkins University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06545669
