Psychoeducation for HCV and Alcohol Behaviors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 556
- 试验地点
- 2
- 主要终点
- Increased treatment readiness and better treatment adherence for treatment of HCV.
研究概览
简要总结
The proposed project will apply a unique, effective family-responsive psychoeducation program, PsychoEducation Responsive to Families (PERF), for Hepatitis C Virus (HCV) treatment. The goal is to demonstrate that the intervention will enlarge the eligibility of some patients for HCV treatment and help sustain others through it.
详细描述
This study aims to evaluate the utility of a psychosocial intervention (PsychoEducation Responsive to Families; PERF), applied to help patients prepare for and sustain HCV treatment in the treatment setting. Through careful psychiatric diagnosis and multiple longitudinal assessments, this study will also shed further light on the course of comorbid alcohol use, drug use, and other psychiatric syndromes and their interrelationships. The proposed study combines an innovative psychoeducation program with traditional HCV patient care and education. The goal of this work is to improve treatment adherence, allowing individual drug regimens to achieve their optimal effectiveness and reach a wider patient population. Support and sustenance of patients from a psychosocial perspective while they are in treatment should also help deliver more patients to sustained suppression of HCV as well as help presently untreated patients and populations become candidates for this therapy-ultimately reducing the disease burden of increasing numbers of patients needing liver transplantation or facing imminent death.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
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
- •Individuals who are seropositive for HCV as determined by ELISA test and confirmed by direct measure of viral load as part of their clinical care
- •Lack progressive or decompensated liver functions (manifest in jaundice, ascites, variceal bleeding, hepatic encephalopathy)
- •Age at least 18 years
- •Identified family member(s)/significant other(s) also willing to participate in the psychoeducation groups, and
- •Ability to provide informed consent for research participation. "Family" will be defined to include biological relatives, as well as any non-biological individual or significant other considered "family" by either the ill member or his/her immediate family.
排除标准
- •Inability to provide informed consent such as irreversible cognitive impairment precluding participation
- •Progressive or decompensated liver functions (manifest in jaundice, ascites, variceal bleeding, hepatic encephalopathy), and
- •Age <18 years.
结局指标
主要结局
Increased treatment readiness and better treatment adherence for treatment of HCV.
时间窗: Index, Post intervention, and 1 year follow-up
次要结局
- Better social functioning and increased quality of life.(Index, Post intervention, and 1 year follow up)
- Better management of substance abuse and other psychiatric disorders.(Index, Post intervention, and 1 year follow up)