<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04411381</url>
  </required_header>
  <id_info>
    <org_study_id>TELE_RVS</org_study_id>
    <nct_id>NCT04411381</nct_id>
  </id_info>
  <brief_title>Telemedicine-based Model of Care for the Management of Hepatitis C Infected Patients</brief_title>
  <official_title>Telemedicine-based Model of Care for the Management of Hepatitis C Infected Patients: a Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of La Laguna</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of La Laguna</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To achieve World Health Organization 2030 goals of hepatitis C elimination it is mandatory to&#xD;
      document after treatment sustained virological response (SVR). Currently, patients after&#xD;
      completing treatment do not show up for SVR assessment. The main objective of this study is&#xD;
      to evaluate the effectiveness of a telemedicine-based model of care associated with dried&#xD;
      blood spot testing at home to assess hepatitis C sustained virological response after&#xD;
      treatment compared to the traditional model of care.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective, randomized study in which hepatitis C (VHC) infected patients will be&#xD;
      randomized to two strategies for HCV care.&#xD;
&#xD;
      All HCV infected patients will be evaluated in a first face-to-face consultation with the&#xD;
      hepatologist for fibrosis evaluation and treatment prescription the same day. Patients will&#xD;
      be invited to participate if they are: 1) 18 years or older 2) have contact telephone number&#xD;
      3) sing the informed consent 4) have not advanced fibrosis (F3) or cirrhosis (F4) 5) are not&#xD;
      under surveillance by another specialist or drug addiction centre.&#xD;
&#xD;
      Participants will be randomized into two strategies to assess sustained virological response&#xD;
      (SVR) during follow-up:&#xD;
&#xD;
        1. The traditional model of care: one appointment for venipuncture for RNA testing to&#xD;
           assess SVR (undetectable RNA 12 weeks after treatment cessation), and an appointment&#xD;
           with the specialist for result communication.&#xD;
&#xD;
        2. Telemedicine-based model of care: The patient will be provided with a home kit to&#xD;
           perform the dried blood spot (DBS) testing for HCV RNA at 12 weeks (SVR), and an&#xD;
           appointment for teleconsultation and communicate the results.&#xD;
&#xD;
      Demographic, clinical and laboratory data will be collected to evaluate the characteristics&#xD;
      of included patients and to study predictive factors of adherence.&#xD;
&#xD;
      A satisfaction questionnaire will be conducted to compare patients´ satisfaction with both&#xD;
      health care models.&#xD;
&#xD;
      The hypothesis of the study is that the adherence and SVR determination record will increase&#xD;
      using the telemedicine-based model of care.&#xD;
&#xD;
      For the present study, a 20% improvement in the adherence (SVR record) was hypothesized in&#xD;
      the group of patients randomized to the telemedicine-based model of care compared to the&#xD;
      traditional model of care. Taking into account power of 80%, alpha error of 5% and losses of&#xD;
      10% will require 68 patients per group.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">May 25, 2020</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Anticipated">December 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Effectiveness of the two models of care</measure>
    <time_frame>12 months</time_frame>
    <description>SVR record rate</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Acceptance of the intervention with a validated satisfaction questionnaire</measure>
    <time_frame>12 months</time_frame>
    <description>Grade of patient satisfaction with telemedicine by a validated questionnaire</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">136</enrollment>
  <condition>Hepatitis C</condition>
  <condition>Telemedicine</condition>
  <arm_group>
    <arm_group_label>Telemedicine-based model of care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Telemedicine associated with dried blood spot testing at home for RNA test to sustained virological response determination</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Traditional model of care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Tradiotional model of care with venipuncture for RNA test to sustained virological response determination and face-to-face consultation</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Telemedicine</intervention_name>
    <description>Telemedicine associated with dried blood spot testing at home for RNA test to sustained virological response determination</description>
    <arm_group_label>Telemedicine-based model of care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years or older&#xD;
&#xD;
          -  have contact telephone number&#xD;
&#xD;
          -  sing the informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  have advanced fibrosis (F3) or cirrhosis (F4)&#xD;
&#xD;
          -  are under surveillance by another specialist or drug addition center.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Manuel Hernández-Guerra, PhD</last_name>
    <phone>34922678559</phone>
    <email>mhernand@ull.edu.es</email>
  </overall_contact>
  <location>
    <facility>
      <name>Hospital Universitario de Canarias</name>
      <address>
        <city>La Laguna</city>
        <state>Santa CRUZ DE Tenerife</state>
        <zip>38320</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>MANUEL HERNANDEZ GUERRA, PhD</last_name>
      <phone>922678000</phone>
    </contact>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <reference>
    <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.</citation>
    <PMID>31812456</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>31811882</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>29946175</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>31215210</PMID>
  </reference>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>May 27, 2020</study_first_submitted>
  <study_first_submitted_qc>May 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 2, 2020</study_first_posted>
  <last_update_submitted>May 17, 2023</last_update_submitted>
  <last_update_submitted_qc>May 17, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 18, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of La Laguna</investigator_affiliation>
    <investigator_full_name>Manuel Hernandez-Guerra, MD</investigator_full_name>
    <investigator_title>Head of Gastroenterology and Hepatology</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hepatitis A</mesh_term>
    <mesh_term>Hepatitis C</mesh_term>
    <mesh_term>Hepatitis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04411381
org study id: TELE_RVS
nct id: NCT04411381
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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:

        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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Effectiveness of the two models of care
time frame: 12 months
description: SVR record rate
measure: Acceptance of the intervention with a validated satisfaction questionnaire
time frame: 12 months
description: Grade of patient satisfaction with telemedicine by a validated questionnaire
arm group label: Telemedicine-based model of care
arm group type: Active Comparator
description: Telemedicine associated with dried blood spot testing at home for RNA test to sustained virological response determination
arm group label: Traditional model of care
arm group type: No Intervention
description: Tradiotional model of care with venipuncture for RNA test to sustained virological response determination and face-to-face consultation
intervention type: Other
intervention name: Telemedicine
description: Telemedicine associated with dried blood spot testing at home for RNA test to sustained virological response determination
arm group label: Telemedicine-based model of care
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Manuel Hernández-Guerra, PhD
phone: 34922678559
email: mhernand@ull.edu.es
facility: 
status: Recruiting
contact: 
country: Spain
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.
PMID: 31812456
citation: 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.
PMID: 31811882
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.
PMID: 29946175
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.
PMID: 31215210
responsible party type: Principal Investigator
investigator affiliation: University of La Laguna
investigator full name: Manuel Hernandez-Guerra, MD
investigator title: Head of Gastroenterology and Hepatology
mesh term: Hepatitis A
mesh term: Hepatitis C
mesh term: Hepatitis
sharing ipd: No