An interventional study of Telemedicine in Hepatitis C and Telemedicine, sponsored by University of La Laguna. Recruiting at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-05-18.
Sponsored by University of La Laguna · Not applicable, Interventional, and Health services research
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.
2,710 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.
This study's planned enrollment of 136 is above the median of 100 across 1,887 interventional studies indexed under Hepatitis A.
Browse Hepatitis A studies →University of La Laguna is the lead sponsor of 16 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Telemedicine associated with dried blood spot testing at home for RNA test to sustained virological response determination
Other: Telemedicine
Tradiotional model of care with venipuncture for RNA test to sustained virological response determination and face-to-face consultation
Telemedicine associated with dried blood spot testing at home for RNA test to sustained virological response determination
Effectiveness of the two models of care
SVR record rate
Time frame: 12 months
Acceptance of the intervention with a validated satisfaction questionnaire
Grade of patient satisfaction with telemedicine by a validated questionnaire
Time frame: 12 months
Plan to share: No
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University of La Laguna