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
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Acceptability and Feasibility as assessed by completion of modules
研究概览
简要总结
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.
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. 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.
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
盲法说明
The statistical analyst will not be made aware of which treatment group received the intervention.
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 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
排除标准
- •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
研究组 & 干预措施
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: 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: 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)
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.
结局指标
主要结局
Acceptability and Feasibility as assessed by completion of modules
时间窗: 1 month, 3 months, 6 months
Acceptability and Feasibility will be assessed through quantitative and qualitative data on factors including (e.g., number of participant engagement, number of barriers,completion of modules, number of sessions with CHW).
Acceptability and Feasibility as assessed by number of barriers
时间窗: 1 month, 3 months, 6 months
Acceptability and Feasibility will be assessed through quantitative and qualitative data on factors including (e.g., number of participant engagement, number of barriers,completion of modules, number of sessions with CHW).
Acceptability and Feasibility as assessed by number of sessions with CHW
时间窗: 1 month, 3 months, 6 months
Acceptability and Feasibility will be assessed through quantitative and qualitative data on factors including (e.g., number of participant engagement, number of barriers,completion of modules, number of sessions with CHW).
次要结局
- Readiness to quit smoking as assessed by The Readiness Ruler(1 month, 3 months, 6 months)
- Number of participants that continue use of nicotine replacement therapy(1 month, 3 months, 6 months)
- Number of participants that attempt to quit(1 month, 3 months, 6 months)
- Number of participants that start nicotine replacement therapy uptake(1 month, 3 months, 6 months)
- Number of quit attempts(1 month, 3 months, 6 months)
- Number of participants that maintain cessation(1 month, 3 months, 6 months)
- Number of participants that utilize Quit Line services(1 month, 3 months, 6 months)
- Number and frequency of interactions with the community health worker(1 month, 3 months, 6 months)
- Participant satisfaction as assessed by the C-Raven Satisfaction Scale(1 month, 3 months, 6 months)