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临床试验/NCT04411381
NCT04411381招募中不适用

Telemedicine-based Model of Care for the Management of Hepatitis C Infected Patients: a Randomized Clinical Trial

University of La Laguna2 个研究点 分布在 1 个国家目标入组 136 人开始时间: 2020年5月25日最近更新:
适应症

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:

  1. 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.
  2. 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

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

发起方
University of La Laguna
申办方类型
Other
责任方
Principal Investigator
主要研究者

Manuel Hernandez-Guerra, MD

Head of Gastroenterology and Hepatology

University of La Laguna

研究点 (2)

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