Telemedicine-based Model of Care for the Management of Hepatitis C Infected Patients: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 136
- 试验地点
- 2
- 主要终点
- Effectiveness of the two models of care
研究概览
简要总结
To achieve World Health Organization 2030 goals of hepatitis C elimination it is mandatory to document after treatment sustained virological response (SVR). Currently, patients after completing treatment do not show up for SVR assessment. The main objective of this study is to evaluate the effectiveness of a telemedicine-based model of care associated with dried blood spot testing at home to assess hepatitis C sustained virological response after treatment compared to the traditional model of care.
详细描述
This is a prospective, randomized study in which hepatitis C (VHC) infected patients will be randomized to two strategies for HCV care.
All HCV infected patients will be evaluated in a first face-to-face consultation with the hepatologist for fibrosis evaluation and treatment prescription the same day. Patients will be invited to participate if they are: 1) 18 years or older 2) have contact telephone number 3) sing the informed consent 4) have not advanced fibrosis (F3) or cirrhosis (F4) 5) are not under surveillance by another specialist or drug addiction centre.
Participants will be randomized into two strategies to assess sustained virological response (SVR) during follow-up:
- The traditional model of care: one appointment for venipuncture for RNA testing to assess SVR (undetectable RNA 12 weeks after treatment cessation), and an appointment with the specialist for result communication.
- Telemedicine-based model of care: The patient will be provided with a home kit to perform the dried blood spot (DBS) testing for HCV RNA at 12 weeks (SVR), and an appointment for teleconsultation and communicate the results.
Demographic, clinical and laboratory data will be collected to evaluate the characteristics of included patients and to study predictive factors of adherence.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 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
- •18 years or older
- •have contact telephone number
- •sing the informed consent
排除标准
- •have advanced fibrosis (F3) or cirrhosis (F4)
- •are under surveillance by another specialist or drug addition center.
结局指标
主要结局
Effectiveness of the two models of care
时间窗: 12 months
SVR record rate
次要结局
- Acceptance of the intervention with a validated satisfaction questionnaire(12 months)
研究者
Manuel Hernandez-Guerra, MD
Head of Gastroenterology and Hepatology
University of La Laguna
