Ignite Creation Date:
2025-12-24 @ 11:37 PM
Ignite Modification Date:
2025-12-25 @ 9:27 PM
Study NCT ID:
NCT07220356
Status:
RECRUITING
Last Update Posted:
2025-11-21
First Post:
2025-10-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
C-Raven, a Virtual Tobacco Cessation Intervention in Residency Clinics
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014029', 'term': 'Tobacco Use Disorder'}], 'ancestors': [{'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D061485', 'term': 'Tobacco Use Cessation Devices'}, {'id': 'D003150', 'term': 'Community Health Workers'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D000488', 'term': 'Allied Health Personnel'}, {'id': 'D006282', 'term': 'Health Personnel'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-12-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2027-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-20', 'studyFirstSubmitDate': '2025-10-20', 'studyFirstSubmitQcDate': '2025-10-21', 'lastUpdatePostDateStruct': {'date': '2025-11-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-10-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Acceptability and Feasibility as assessed by number of participants who complete modules', 'timeFrame': '1 month'}, {'measure': 'Acceptability and Feasibility as assessed by number of sessions with CHW', 'timeFrame': '1 month, 3 months, 6 months'}, {'measure': 'Number of participants who uptake Low-dose CT Scan', 'timeFrame': '3 months, 6 months'}], 'secondaryOutcomes': [{'measure': 'Readiness to Quit as assessed by The Readiness Ruler', 'timeFrame': '1 month, 3 months, 6 months', 'description': 'The Readiness Ruler is a brief measure of motivation, which uses 10-point visual analog scales on which the participant rates importance, confidence, and readiness, with a score of 0 reflecting "not ready," and a score of 10 reflecting "ready."'}, {'measure': 'Number of participants who uptake Nicotine Replacement Therapy (NRT)', 'timeFrame': '3 months, 6 months'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Tobacco Dependence']}, 'descriptionModule': {'briefSummary': 'In a residency clinic in Baltimore, the investigators propose to conduct a pilot 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.\n\nWith a sample of participants from the residency clinic (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. The investigators will conduct interviews with a subset of pilot participants to collect qualitative data on intervention acceptability.', 'detailedDescription': "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. 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.\n\nParticipants (N=30) will be recruited through referrals from resident clinicians as well as flyers in the clinic space. 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 site. 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.\n\nConsent process: After confirming eligibility with screening questions, potential participants will complete the consent process and sign the consent form at the beginning of the first in-person visit.\n\nRandomization: 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.\n\nBaseline 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.\n\nIntervention:\n\nComputer-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.\n\nComputer-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.\n\nCommunity 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).\n\nLinkage 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 participant's 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)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age 50 or older\n* Current tobacco use with \\>100 cigarettes smoked in the participant's lifetime\n* Considering smoking cessation\n* Planning to remain in local area for at least 6 months\n* English speaking (intervention currently in English only)\n\nExclusion Criteria:\n\n* Contraindication to nicotine replacement therapy\n* Current engagement in formal smoking cessation program\n* Major cognitive or psychiatric impairment\n* Severe hearing impairment\n* Investigator discretion"}, 'identificationModule': {'nctId': 'NCT07220356', 'briefTitle': 'C-Raven, a Virtual Tobacco Cessation Intervention in Residency Clinics', 'organization': {'class': 'OTHER', 'fullName': 'Johns Hopkins University'}, 'officialTitle': 'C-Raven: Pilot RCT of an Avatar-delivered Computerized Intervention for Tobacco Cessation With Community Health Worker Linkage to Lung Cancer Screening in Baltimore City (FY26)', 'orgStudyIdInfo': {'id': 'IRB00450397-2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'C-Raven + CHW Smoking Cessation Intervention', 'description': 'Participants will receive a virtual counselor intervention for smoking cessation, be offered the opportunity to utilize nicotine replacement therapies, participate in shared decision-making around lung cancer screening, and be supported by a community health worker. Participants will be followed for a total of 6 months. Assessments will be conducted at baseline, 1 month, 3 months, and 6 months.', 'interventionNames': ['Behavioral: C-Raven Virtual Tobacco Cessation Counseling', 'Drug: Nicotine Replacement Product', 'Other: Community Health Worker', 'Other: Lung Cancer Screening']}, {'type': 'NO_INTERVENTION', 'label': 'No Intervention', 'description': 'Participants will not receive any intervention during the first 6 months of the study. The participants will receive the study intervention at the end of 6 months, to ensure access to treatment for all participants.'}], 'interventions': [{'name': 'C-Raven Virtual Tobacco Cessation Counseling', 'type': 'BEHAVIORAL', '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.', 'armGroupLabels': ['C-Raven + CHW Smoking Cessation Intervention']}, {'name': 'Nicotine Replacement Product', 'type': 'DRUG', 'description': 'Participants will be offered up to a 12-week supply of nicotine patches and either nicotine gum or lozenges.', 'armGroupLabels': ['C-Raven + CHW Smoking Cessation Intervention']}, {'name': 'Community Health Worker', 'type': 'OTHER', '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.', 'armGroupLabels': ['C-Raven + CHW Smoking Cessation Intervention']}, {'name': 'Lung Cancer Screening', 'type': 'OTHER', 'description': 'After participating in shared decision-making, eligible participants will be referred to primary care physician or existing specialist to complete lung cancer screening.', 'armGroupLabels': ['C-Raven + CHW Smoking Cessation Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21205', 'city': 'Baltimore', 'state': 'Maryland', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Alejandra Ellison-Barnes, MD', 'role': 'CONTACT', 'email': 'aelliso6@jhmi.edu', 'phone': '410-614-1135'}, {'name': 'Heidi Hutton, PhD', 'role': 'CONTACT', 'email': 'hhutton@jhmi.edu', 'phone': '443-287-2874'}], 'facility': 'Johns Hopkins University School of Medicine', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'centralContacts': [{'name': 'Alejandra Ellison-Barnes, MD', 'role': 'CONTACT', 'email': 'aelliso6@jhmi.edu', 'phone': '410-614-1135'}, {'name': 'Heidi Hutton, PhD', 'role': 'CONTACT', 'email': 'hhutton@jhmi.edu', 'phone': '443-287-2874'}], 'overallOfficials': [{'name': 'Alejandra Ellison-Barnes, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins School of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johns Hopkins University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Maryland Cigarette Restitution Fund', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}