- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04411381
Telemedicine-based Model of Care for the Management of Hepatitis C Infected Patients
Telemedicine-based Model of Care for the Management of Hepatitis C Infected Patients: a Randomized Clinical Trial
Study Overview
Detailed 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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Manuel Hernández-Guerra, PhD
- Phone Number: 34922678559
- Email: mhernand@ull.edu.es
Study Locations
-
-
Santa CRUZ DE Tenerife
-
La Laguna, Santa CRUZ DE Tenerife, Spain, 38320
- Recruiting
- Hospital Universitario de Canarias
-
Contact:
- MANUEL HERNANDEZ GUERRA, PhD
- Phone Number: 922678000
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Telemedicine-based model of care
Telemedicine associated with dried blood spot testing at home for RNA test to sustained virological response determination
|
Telemedicine associated with dried blood spot testing at home for RNA test to sustained virological response determination
|
No Intervention: Traditional model of care
Tradiotional model of care with venipuncture for RNA test to sustained virological response determination and face-to-face consultation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Effectiveness of the two models of care
Time Frame: 12 months
|
SVR record rate
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Acceptance of the intervention with a validated satisfaction questionnaire
Time Frame: 12 months
|
Grade of patient satisfaction with telemedicine by a validated questionnaire
|
12 months
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TELE_RVS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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