Hepatitis CNCT04411381
Telemedicine-based Model of Care for the Management of Hepatitis C Infected Patients
A study testing Telemedicine in people with Hepatitis C and Telemedicine, run by University of La Laguna at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C, Telemedicine
- What is being tested?
- Telemedicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 1 siteSpain
- Study dates
- 25 May 2020to Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years or older
- have contact telephone number
- sing the informed consent
Who cannot join
- have advanced fibrosis (F3) or cirrhosis (F4)
- are under surveillance by another specialist or drug addition center.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario de Canarias
San Cristóbal de La Laguna, Santa CRUZ DE Tenerife, 38320
MANUEL HERNANDEZ GUERRA, PhD, 922678000
About this study
Official title: Telemedicine-based Model of Care for the Management of Hepatitis C Infected Patients: a Randomized Clinical Trial
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.
Read the 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.
- Conditions
- Hepatitis C, Telemedicine
- Being tested
- Telemedicine
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelemedicineOther
Telemedicine associated with dried blood spot testing at home for RNA test to sustained virological response determination
| Study group | Role | What they receive |
|---|---|---|
| Telemedicine-based model of care | Active comparator | Telemedicine associated with dried blood spot testing at home for RNA test to sustained virological response determination Receives: Other: Telemedicine |
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of the two models of care
SVR record rate
Measured: 12 months
Secondary outcomes (1)
Acceptance of the intervention with a validated satisfaction questionnaire
Grade of patient satisfaction with telemedicine by a validated questionnaire
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2020
- Study start25 May 2020
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 136 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of La Laguna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manuel Hernandez-Guerra, MD, University of La Laguna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04411381
- Sponsor's protocol ID
- TELE_RVS
- Status last verified
- May 2023
- First submitted
- 27 May 2020
- Last updated
- 18 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 31812456Averhoff 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.
PubMed 31811882Cuadrado 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.
PubMed 29946175Jimenez 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.
PubMed 31215210
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telemedicine-based Model of Care for the Management of Hepatitis C Infected Patients: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04411381
- Acronym / sponsor ID
- TELE_RVS
- Conditions
- Hepatitis C, Telemedicine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 136 participants (estimated)
- Lead sponsor
- University of La LagunaUniversity, hospital or other
- Study start
- 25 May 2020 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 2 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telemedicine-based model of care | Active comparator | Other: TelemedicineTelemedicine 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years or older
- have contact telephone number
- sing the informed consent
Key exclusion criteria (2 listed)
- have advanced fibrosis (F3) or cirrhosis (F4)
- are under surveillance by another specialist or drug addition center.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TelemedicineTelemedicine associated with dried blood spot testing at home for RNA test to sustained virological response determination | Other | Telemedicine-based model of care |
Primary outcome
Effectiveness of the two models of care
Time frame: 12 months
SVR record rate
1 secondary outcome
Acceptance of the intervention with a validated satisfaction questionnaire
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2023.
- Background: PubMed 31812456Gomez 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.
- Background: PubMed 31811882Averhoff 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.
- Background: PubMed 29946175Cuadrado 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.
- Background: PubMed 31215210Jimenez 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telemedicine in people with Hepatitis C and Telemedicine, run by University of La Laguna at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Manuel Hernández-Guerra, PhD (34922678559, mhernand@ull.edu.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness of the two models of care (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04411381, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2023; AzTrials last refreshed its copy on 8 Nov 2026.