Clinical Trial to Evaluate Efficacy and Acceptance of a Telemedicine Based Programme to Treat Hepatitis C Among Patients at Drug Addiction Centers
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 166
- 试验地点
- 2
- 主要终点
- Efficacy of the intervention
研究概览
简要总结
The investigators have designed a community-based intervention study to all subjects attended in drug addiction centers screened for hepatitis C virus (HCV) to evaluate the efficacy and acceptance of a telemedicine based programme versus conventional healthcare assistance
详细描述
Our current programme of engagement to healthcare and HCV screening based on on-site dried blood spot (DBS) testing has shown to be successful, but with drop-outs in the HCV cascade of care due to economic reasons that difficulties travel costs to appointments, unconsciousness of disease and low awareness of new direct acting antiviral benefits. In this setting, videoconference as a complement to use of serologic scores and dispensing medication outside the hospital could be useful to improve adherence and reduce drop-outs by reducing the visits to hospital from drug addiction centers (DAC), and promoting direct information regarding benefits of been treated with new antivirals free of interferon directly from specialists.
The hypothesis of the study is that the rate of those diagnosed, fully evaluated of liver disease stage, treated and cured will be improved with a lower rate of drop-outs in the cascade of care in the telemedicine arm compared with the conventional arm without affecting satisfaction in the healthcare assistance process.
This is a prospective, randomized, study in which subjects attending DAC will be invited to participate and sign a consent form.
Aims:
- Evaluation of efficacy (compliance rate with the programme which includes completing screening, liver disease evaluation, and treatment)
- Evaluation of acceptance (grade of patient satisfaction of the programme)
- Evaluation of sustained virological response rate and time to achieve eradication
- The adherence rate to follow-up in participants with advanced fibrosis and cirrhosis
- To assess factors associated with drop-outs
- Cost-effectiveness analysis of the telemedicine programme
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Subjects 18 years old or older with a valid sanitary card in our public health system
- •Signed Informed consent
- •Tested for HCV: a) no previous documented HCV antibody request or b) with a previous positive HCV antibody test without RNA result or positive result without treatment or confirmed sustained virological response or c) with a negative HCV antibody result tested more than one year ago
- •No current surveillance by any hepatitis specialized care (hepatology or internal medicine)
排除标准
- •Previous DBS testing at DAC lost to follow-up
结局指标
主要结局
Efficacy of the intervention
时间窗: 12 months
Compliance rate (number of patients of the overall participants) with the programme which includes completing screening, liver disease evaluation, treatment and follow-up visit at 12 week
次要结局
- Demographic factors associated with drop-outs(12 months)
- Acceptance of the intervention with validated satisfaction questionnaire(12 months)
- Time to sustained virological response rate(12 months)
- Adherence rate to follow-up(12 months)
- Sustained virological response rate(12 months)
- Cost-effectiveness of telemedicine strategy(12 months)
研究者
Manuel Hernandez-Guerra, MD
Principal Investigator
University of La Laguna