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

Hepatitis C Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04411381
• Other study ID #: TELE_RVS
• Status: Recruiting
• Phase: N/A
• Start date: May 25, 2020
• Est. completion date: December 2023

Study information

• Verified date: May 2023
• Source: University of La Laguna
• Contact: Manuel Hernández-Guerra, PhD
• Phone: 34922678559
• Email: mhernand[@]ull.edu.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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:

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 136
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Telemedicine

Intervention

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

Locations

Country	Name	City	State
Spain	Hospital Universitario de Canarias	La Laguna	Santa CRUZ DE Tenerife

Sponsors (1)

Lead Sponsor	Collaborator
University of La Laguna

Country where clinical trial is conducted

Spain, 

References & Publications (4)

Averhoff F, Shadaker S, Gamkrelidze A, Kuchuloria T, Gvinjilia L, Getia V, Sergeenko D, Butsashvili M, Tsertsvadze T, Sharvadze L, Zarkua J, Skaggs B, Nasrullah M. Progress and challenges of a pioneering hepatitis C elimination program in the country of Georgia. J Hepatol. 2020 Apr;72(4):680-687. doi: 10.1016/j.jhep.2019.11.019. Epub 2019 Dec 4. — View Citation

Cuadrado A, Llerena S, Cobo C, Pallas JR, Mateo M, Cabezas J, Fortea JI, Alvarez S, Pellon R, Crespo J, Echevarria S, Ayesa R, Setien E, Lopez-Hoyos M, Crespo-Facorro B, Aguero J, Chueca N, Garcia F, Calleja JL, Crespo J. Microenvironment Eradication of Hepatitis C: A Novel Treatment Paradigm. Am J Gastroenterol. 2018 Nov;113(11):1639-1648. doi: 10.1038/s41395-018-0157-x. Epub 2018 Jun 27. — View Citation

Gomez L, Reygosa C, Morales-Arraez DE, Ramos R, Perez A, Hernandez A, Quintero E, Gutierrez F, Diaz-Flores F, Hernandez-Guerra M. Diagnostic test accuracy of the cobas 6800 system for detection of hepatitis c virus viraemia levels from dried blood spots. Enferm Infecc Microbiol Clin (Engl Ed). 2020 Jun-Jul;38(6):267-274. doi: 10.1016/j.eimc.2019.10.009. Epub 2019 Dec 4. English, Spanish. — View Citation

Jimenez Galan G, Alia Alia C, Vegue Gonzalez M, Garcia Berriguete RM feminine, Fernandez Gonzalez F, Fernandez Rodriguez CM, Gonzalez Fernandez M, Gutierrez Garcia ML, Losa JE, Velasco M, Moreno L, Hervas R, Delgado-Iribarren A, Palacios Garcia-Cervigon G. The contribution of telemedicine to hepatitis C elimination in a correctional facility. Rev Esp Enferm Dig. 2019 Jul;111(7):550-555. doi: 10.17235/reed.2019.6152/2018. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effectiveness of the two models of care	SVR record rate	12 months
Secondary	Acceptance of the intervention with a validated satisfaction questionnaire	Grade of patient satisfaction with telemedicine by a validated questionnaire	12 months