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)
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Acceptability and Feasibility as assessed by number of participants who complete modules
研究概览
简要总结
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.
With 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.
详细描述
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.
Participants (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.
Consent 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.
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 50 or older
- •Current tobacco use with >100 cigarettes smoked in the participant's lifetime
- •Considering smoking cessation
- •Planning to remain in local area for at least 6 months
- •English speaking (intervention currently in English only)
排除标准
- •Contraindication to nicotine replacement therapy
- •Current engagement in formal smoking cessation program
- •Major cognitive or psychiatric impairment
- •Severe hearing impairment
- •Investigator discretion
研究组 & 干预措施
No Intervention
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.
C-Raven + CHW Smoking Cessation Intervention
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.
干预措施: Nicotine Replacement Product (Drug)
C-Raven + CHW Smoking Cessation Intervention
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.
干预措施: C-Raven Virtual Tobacco Cessation Counseling (Behavioral)
C-Raven + CHW Smoking Cessation Intervention
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.
干预措施: Community Health Worker (Other)
C-Raven + CHW Smoking Cessation Intervention
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.
干预措施: Lung Cancer Screening (Other)
结局指标
主要结局
Acceptability and Feasibility as assessed by number of participants who complete modules
时间窗: 1 month
Acceptability and Feasibility as assessed by number of sessions with CHW
时间窗: 1 month, 3 months, 6 months
Number of participants who uptake Low-dose CT Scan
时间窗: 3 months, 6 months
次要结局
- Readiness to Quit as assessed by The Readiness Ruler(1 month, 3 months, 6 months)
- Number of participants who uptake Nicotine Replacement Therapy (NRT)(3 months, 6 months)