Ignite Creation Date:
2024-05-06 @ 2:45 PM
Last Modification Date:
2024-10-26 @ 1:36 PM
Study NCT ID:
NCT04411381
Status:
RECRUITING
Last Update Posted:
2023-05-18
First Post:
2020-05-27
Brief Title:
Telemedicine-based Model of Care for the Management of Hepatitis C Infected Patients
Sponsor:
University of La Laguna
Organization:
University of La Laguna
Study Overview
Official Title:
Telemedicine-based Model of Care for the Management of Hepatitis C Infected Patients a Randomized Clinical Trial
Status:
RECRUITING
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None