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临床试验/NCT05466981
NCT05466981已完成不适用

Smoking Cessation Intervention for Persons Infected With Hepatitis C Virus

Prisma Health-Upstate1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2020年11月23日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
10
试验地点
1
主要终点
Change in the number of cigarettes smoked per day (CPD)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Adults (≥18 years old)
  • •Current HCV infection (HCV RNA+)
  • •Current cigarette smoking
  • •Patients in contemplation / preparation stage of change

排除标准

  • •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

研究组 & 干预措施

Current smokers with an HCV infection

Experimental

Persons who currently smoke cigarettes and are also HCV RNA+

干预措施: Cognitive Behavioral Counseling (Behavioral)

结局指标

主要结局

Change in the number of cigarettes smoked per day (CPD)

时间窗: baseline (week 0) to end of treatment (week 12)

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.

Change in Fagerstrom Test for Nicotine Dependence (FTND) score

时间窗: 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.

次要结局

  • Change in depressive symptomology using Patient Health Questionnaire (PHQ-9) score(baseline (week 0) to end of treatment (week 12))
  • Number of quit attempts(baseline (week 0) to end of treatment (week 12))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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