Telemedicine-based Model of Care for the Management of Hepatitis C Infected Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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. A satisfaction questionnaire will be conducted to compare patients´ satisfaction with both health care models. The hypothesis of the study is that the adherence and SVR determination record will increase using the telemedicine-based model of care. For the present study, a 20% improvement in the adherence (SVR record) was hypothesized in the group of patients randomized to the telemedicine-based model of care compared to the traditional model of care. Taking into account power of 80%, alpha error of 5% and losses of 10% will require 68 patients per group.

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

Conditions
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Hepatitis C, Telemedicine

Intervention / Treatment
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* Other: Telemedicine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years or older have contact telephone number sing the informed consent Exclusion Criteria: have advanced fibrosis (F3) or cirrhosis (F4) are under surveillance by another specialist or drug addition center.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Telemedicine-based model of care<br>Telemedicine associated with dried blood spot testing at home for RNA test to sustained virological response determination | Other: Telemedicine<br>* Telemedicine associated with dried blood spot testing at home for RNA test to sustained virological response determination<br>|
| No Intervention: Traditional model of care<br>Tradiotional model of care with venipuncture for RNA test to sustained virological response determination and face-to-face consultation | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness of the two models of care | SVR record rate | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acceptance of the intervention with a validated satisfaction questionnaire | Grade of patient satisfaction with telemedicine by a validated questionnaire | 12 months |