Health Behavior Feedback Study for Veterans With Hepatitis C
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Reduction in alcohol consumption
研究概览
简要总结
The purpose of this study was to explore whether a brief (3 session) intervention would impact health behavior of veterans with hepatitis C. The main focus of the intervention was on reduction of heavy drinking with patients who have liver disease. Other study goals were to increase the likelihood that patients would seek out substance use treatment and/or hepatitis C health care services. The study also tested the use of a liver function test called CDT/GGT in detecting heavy drinking. The main hypothesis was that a 3 session intervention with personalized feedback about health behavior would result in a reduction in alcohol use and increased use of substance use treatment and hepatology health care.
详细描述
OBJECTIVES: To establish the feasibility of a brief intervention for hepatitis C+ (HCV) patients who drink alcohol. The primary aim was reduction in alcohol use, which is known to be hazardous for patients with chronic HCV infection. Secondary aims were: 1) to increase patient engagement in substance use disorder (SUD) treatment, 2) to explore patient engagement in HCV specialty care, treatment acceptability, and impact on other health-related behaviors, and 3) to examine pre-post intervention differences in relation to report of alcohol use and to explore whether the CDT/GGT merits tracking to detect heavy drinking in this population, given hepatic pathology.
DESIGN: Randomized controlled trial with six-week and 12-week post-baseline assessment follow-up. The control group was offered the brief intervention at completion of the 12-week post-baseline follow-up.
PARTICIPANTS: We had anticipated recruiting 60 veterans who were HCV+, referred for HCV specialty care (education or treatment evaluation), and who met criteria for hazardous alcohol use. Due to problems with recruitment, only 12 veterans participated in the study (see below).
RECRUITMENT: We started regular study recruitment September 27, 2004 but study recruitment was much slower than anticipated. Despite multiple modifications to change our recruitment eligibility criteria, we enrolled only twelve subjects (N=12). Due to this ongoing recruitment problem, we decided to end study enrollment on 9/30/05 with follow-up completion in December 2005. Despite an extension of the Alcoholic Beverage Medical Research Foundation grant, there was no progress in identifying an alternative recruitment or developing an appropriate follow-up study.
MEASURES: Baseline assessment included demographic information, the Alcohol Use Disorders Identification Test (AUDIT), Form - 90 (recent alcohol and drug use), a DSM-IV SUD criteria checklist, a Health Behavior Questionnaire, and the K-10 (brief measure of psychological distress). For brief intervention feedback, the Short Inventory of Problems (negative consequences of alcohol use), the SOCRATES (stage of readiness to change), blood draw for liver function tests, and two brief measures of neuropsychological functioning were administered. VA treatment utilization data (SUD and specialty HCV treatment attendance) was obtained. Follow-up sessions also included measures of treatment acceptability and concept retention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Positive serology for current infection by hepatitis C viremia by PCR confirmation test;
- •Current alcohol use (past 30 days) as indicated by self-report (using AUDIT- C questions);
- •Meets hazardous alcohol use criteria as measured by the Alcohol Use Disorders Identification Test.
- •Criteria per (National Institute on Alcohol Abuse and Alcoholism, 1995):
- •for women, 7 or more drinks per week or 4 or more drinks per occasion;
- •for men, 14 or more drinks per week or 5 or more drinks per occasion;
- •Not currently engaged (past 30 days) in VA specialty substance use disorder treatment or mutual help groups like AA/NA.
排除标准
- •Abstinent from alcohol use in last 30 days as indicated by self-report or less than hazardous use according to criteria listed above by the AUDIT.
- •Patient is already engaged (past 30 days) in specialty substance use disorder treatment or attends self-help groups.
结局指标
主要结局
Reduction in alcohol consumption
时间窗: at 6 and 12-week follow-up.
次要结局
- Engagement in substance use treatment and hepatitis C specialty care. Detection of elevated CDT in blood serum compared with self-reported heavy drinking.(12 weeks post-study)