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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Telemedicine-based model of care | Active Comparator | Telemedicine associated with dried blood spot testing at home for RNA test to sustained virological response determination |
|
| Traditional model of care | No Intervention | Tradiotional model of care with venipuncture for RNA test to sustained virological response determination and face-to-face consultation |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telemedicine | Other | Telemedicine associated with dried blood spot testing at home for RNA test to sustained virological response determination |
|
| Measure | Description | Time Frame |
|---|---|---|
| Effectiveness of the two models of care | SVR record rate | 12 months |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Manuel Hernández-Guerra, PhD | Contact | 34922678559 | mhernand@ull.edu.es |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario de Canarias | Recruiting | San Cristóbal de La Laguna | Santa CRUZ DE Tenerife | 38320 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31812456 | Background | 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. | |
| 31811882 |
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| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
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| ID | Term |
|---|---|
| D017216 | Telemedicine |
| ID | Term |
|---|---|
| D003695 | Delivery of Health Care |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |
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| Background |
| 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. |
| 29946175 | Background | 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. |
| 31215210 | Background | 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. |
| D014777 |
| Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |