Telemedicine-based Model of Care for the Management of Hepatitis C Infected Patients
NCT ID: NCT04411381
Last Updated: 2023-05-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
136 participants
INTERVENTIONAL
2020-05-25
2023-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Telemedicine-based model of care
Telemedicine associated with dried blood spot testing at home for RNA test to sustained virological response determination
Telemedicine
Telemedicine associated with dried blood spot testing at home for RNA test to sustained virological response determination
Traditional model of care
Tradiotional model of care with venipuncture for RNA test to sustained virological response determination and face-to-face consultation
No interventions assigned to this group
Interventions
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Telemedicine
Telemedicine associated with dried blood spot testing at home for RNA test to sustained virological response determination
Eligibility Criteria
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Inclusion Criteria
* have contact telephone number
* sing the informed consent
Exclusion Criteria
* are under surveillance by another specialist or drug addition center.
18 Years
ALL
No
Sponsors
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University of La Laguna
OTHER
Responsible Party
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Manuel Hernandez-Guerra, MD
Head of Gastroenterology and Hepatology
Locations
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Hospital Universitario de Canarias
San Cristóbal de La Laguna, Santa CRUZ DE Tenerife, Spain
Countries
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Central Contacts
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Facility Contacts
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MANUEL HERNANDEZ GUERRA, PhD
Role: primary
References
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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.
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.
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.
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.
Other Identifiers
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TELE_RVS
Identifier Type: -
Identifier Source: org_study_id
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