Uptake of Varenicline and Strategies for Enhanced Engagement in Treatment for Smoking Cessation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 94
- 试验地点
- 1
- 主要终点
- Acceptability of the experimental video intervention
研究概览
简要总结
The study goal is to get feedback on ways researchers can communicate complex research findings on smoking cessation to better inform patients' decisions to use medication and/or quit smoking. This will help researchers and clinicians to provide effective, easy-to-implement treatments designed to address tobacco-related health disparities in Black and other racial/ethnic subgroups. It will also help improve health literacy to change misperceptions and mistrust on uptake of varenicline and other medication for quitting smoking. A professionally made video will explain research findings relevant for varenicline's mechanisms and outcomes relative to other treatment options.
There are 2 parts to this study:
- Part 1: Focus Group to help develop the educational tool intervention
- Part 2: Randomized portion of study. In this part of the study, participants will be randomized (like flip of coin) to take part in receive the experimental educational intervention or usual methods to help stop smoking. Participants in either arm can choose to receive varenicline and it will be provided as part of study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients must smoke at least 10 cigarettes/day and do not currently use a smoking cessation medication.
- •Agree to complete surveys and measures within study.
- •Ability to understand English and the willingness to sign a written informed consent document.
排除标准
- •Patients who are receiving any other smoking cessation medications.
- •Patients who are pregnant and/or lactating.
- •Patients with psychiatric contraindications that can prevent adherence to protocol or use of intervention tools in study. For inclusivity on trial, psychiatric contraindications and ability for patient to participate in trial will be assessed on an individual basis by study investigator.
- •Patients who have a contraindication with varenicline.
研究组 & 干预措施
Educational Intervention
Study participants will watch a video containing research findings related to smoking cessation and information on varenicline, a medication to help patients quit smoking.
For participants who select varenicline and/or nicotine replacement, medications will be mailed to their residence and standard follow-up and medication support practices will be adhered to check on progress.
Participants will be randomized to between educational intervention and usual care arm.
Some participants who have no access to a video-enabled device or reliable internet and will provide them a tablet with broadband internet for a period of 3 months.
干预措施: Educational Video (Behavioral)
Treatment-as-usual (TAU)
Treatment-as-usual (TAU) session with discussion of FDA-approved smoking medication. Treatment as usual includes discussion and facts about cessation medication options as a standard of care with a standard video on smoking cessation treatment.
For participants who select varenicline and/or nicotine replacement, medications will be mailed to their residence and standard follow-up and medication support practices will be adhered to check on progress.
Some participants who have no access to a video-enabled device or reliable internet and will provide them a tablet with broadband internet for a period of 3 months.
Focus Group
3 focus groups with 6-8 patients each to provide feedback on video production format and salience of relevant content
结局指标
主要结局
Acceptability of the experimental video intervention
时间窗: 24 weeks
This will be assessed using a modified version of the Client Satisfaction Questionnaire which assesses items such as quality, effectiveness, and intrusiveness on the 10-point Likert scale (0=not at all, 10=very much).
Determine whether provision of technology access and support will improve program attendance and smoking outcomes
时间窗: 24 weeks
This will be assessed using a modified version of the Client Satisfaction Questionnaire specific to technology component which assesses items such as quality, effectiveness, and intrusiveness on the 10-point Likert scale (0=not at all, 10=very much).
Trial feasibility
时间窗: End of study recruitment (6 months)
ability to enroll and follow-up with the planned number of participants within the specified time frame.
次要结局
未报告次要终点