Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06545669
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-06
Brief Title:
C-Raven a Virtual Tobacco Cessation Intervention in the Community
Sponsor:
None
Organization:
None
Study Overview
Official Title:
C-Raven Pilot Randomized Controlled Trial RCT of an Avatar-delivered Computerized Intervention for Tobacco Cessation With Community Health Worker Linkage to Lung Cancer Screening in Baltimore City
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 N30 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
With a sample of participants from public housing units N30 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 N30 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 questionnairesassessments 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 eg 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 barriersfacilitators 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 eg 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 NormalNormal with Minor FindingsAbnormal Needing Short-Term Follow-UpAbnormal Needing Immediate Follow-Up
Participants N30 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 questionnairesassessments 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 eg 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 barriersfacilitators 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 eg 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 NormalNormal with Minor FindingsAbnormal Needing Short-Term Follow-UpAbnormal Needing Immediate Follow-Up
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None