HCV-Smoking Cessation Study
2022年7月18日 更新者：Prisma Health-Upstate
Smoking Cessation Intervention for Persons Infected With Hepatitis C Virus
A 12-week study for patients who are being treated for Hepatitis C and would like to quit smoking.
During the 12 weeks of Hepatitis C treatment, the research team will have counseling sessions with the participants to discuss challenges related to Hepatitis C and smoking.
研究概览
详细说明
A 12-week smoking cessation intervention addressing concurrently HCV and smoking cessation The Standard of care for HCV is 12 weeks of oral medication with 3 in-person provider/laboratory visits throughout.
This study utilizes both in-person and phone counseling and health education sessions.
Each session will address a different topic related to HCV, smoking, and how both smoking and HCV affect health and quality of life.
研究类型
介入性
注册 (实际的)
10
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
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South Carolina
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Greenville、South Carolina、美国、29605
- Prisma Health Internal Medicine Clinic
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Adults (≥18 years old)
- Current HCV infection (HCV RNA+)
- Current cigarette smoking
- Patients in contemplation / preparation stage of change
Exclusion Criteria:
- Inability to speak/read English, as materials will be provided in English
- Current suicidal ideation as determined by the PHQ-9, requiring a greater level of clinical care
- Severe medical or psychiatric disability that prevents participant from ability to comprehend or consent to study
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Current smokers with an HCV infection
Persons who currently smoke cigarettes and are also HCV RNA+
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The intervention consisted of 12 weeks of HCV treatment combined with smoking cessation pharmacotherapy and brief behavioral counseling conducted by a LMSW.
The brief behavioral counseling consisted of cognitive behaioral components and was provided by phone and in-person.
The intervention followed these 5 phases: increase motivation to quit smoking, quit attempt, maintain short-term abstinence, and lapse and relapse prevention.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in the number of cigarettes smoked per day (CPD)
大体时间：baseline (week 0) to end of treatment (week 12)
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We will track the number of cigarettes the participant smokes per day at each weekly visit, then compare the CPD at baseline during week 0 to the end of treatment at week 12.
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baseline (week 0) to end of treatment (week 12)
|
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Change in Fagerstrom Test for Nicotine Dependence (FTND) score
大体时间：baseline (week 0) to end of treatment (week 12)
|
We will calculate the participant's FTND score at the baseline visit during week 0 and compare it to their FTND score at the end of treatment visit during week 12.
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baseline (week 0) to end of treatment (week 12)
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in depressive symptomology using Patient Health Questionnaire (PHQ-9) score
大体时间：baseline (week 0) to end of treatment (week 12)
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We will calculate the participant's PHQ-9 score at the baseline visit during week 0 and compare it to their PHQ-9 score at the end of treatment visit during week 12.
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baseline (week 0) to end of treatment (week 12)
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Number of quit attempts
大体时间：baseline (week 0) to end of treatment (week 12)
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We will measure the number of quit attempts made throughout the intervention from baseline to end of treatment.
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baseline (week 0) to end of treatment (week 12)
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Irene Pericot-Valverde, PhD、Prisma Health
- 研究主任：Alain Litwin, MD、Prisma Health
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2020年11月23日
初级完成 (实际的)
2021年11月11日
研究完成 (实际的)
2021年11月11日
研究注册日期
首次提交
2021年7月26日
首先提交符合 QC 标准的
2022年7月18日
首次发布 (实际的)
2022年7月20日
研究记录更新
最后更新发布 (实际的)
2022年7月20日
上次提交的符合 QC 标准的更新
2022年7月18日
最后验证
2021年7月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.