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

University of La Laguna

Status: Enrolling

Conditions: Hepatitis C; Telemedicine

Treatments: Other: Telemedicine

Study type: Interventional

Funder types: Other

Identifiers

NCT04411381

TELE_RVS

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 136 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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136 participants in 2 patient groups

Telemedicine-based model of care

Active Comparator group

Description:

Telemedicine associated with dried blood spot testing at home for RNA test to sustained virological response determination

Treatment:

Other: Telemedicine

Traditional model of care

No Intervention group

Description:

Tradiotional model of care with venipuncture for RNA test to sustained virological response determination and face-to-face consultation