Hepatitis C Clinical Trial
Official title:
Efficacy of a Nursing Monitoring Program for Detection and Treatment of Hepatitis C in a Population With Severe Mental Disorder.
It has been described in the scientific literature that people diagnosed with serious mental disorders, such as psychosis and schizophrenia, have difficulties to access medical treatments for their physical illnesses, which produces excess mortality in this population. This project will consist of three different parts. The first will be the detection and accurate diagnosis of hepatitis C (HCV) in the population diagnosed with a severe mental disorder (SMD). It will find the prevalence of people with infection who have not been diagnosed, as well as that of people diagnosed but who have not completed treatment. Likewise, the characteristics of the sample obtained and the risk factors associated with positive cases will be analyzed. The second part of the study will consist of comparing the effectiveness of an individualized monitoring programme (NURSE-NAVIGATION PROGRAMME), carried out by the specialist mental health nurse, during the treatment of hepatitis C versus the usual health care. In order to fulfill these first two objectives, a Clinical Pathway will be opened in which the Microbiology, Gastroenterology, Pharmacy and Mental Health services of the Regional University Hospital of Malaga will participate. The third objective of the project will be to study how the presence of Hepatitis C influences psychotic symptoms, mainly negative ones, changes in daily functioning and changes in quality of life . For these purposes we will use the PANSS scale, a Quality of Life scale (the Life Skill Profile) and the Euroqol5D Health Questionaire before treatment and after verifying the effective cure of HCV. A third and final evaluation with all the study variables will be carried out 6 months after starting the treatment. In addition, the disappearance of the viral load and, therefore, the patient's cure will be determined with a new blood test.
The objective of this study is to compare the effectiveness of a nurse-navigation program developed by specialist nurses on mental health, for patients with HCV and SMD, against the usual standard care, regarding the detection of the disease, facilitation of access and adherence to treatment, guides through the healthcare system, and cure from HCV. The null hypothesis that this study will test is that there are no differences in the HCV cure rate in SMD subjects who receive the nurse-navigation model versus those who receive usual care. Additionally, a second hypothesis will be tested regarding to the differences in the adherence to HCV treatment. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03686722 -
Effect of Co-administration of Metformin and Daclatasvir on the Pharmacokinetis and Pharmacodynamics of Metformin
|
Phase 1 | |
| Recruiting |
NCT04510246 -
Link Hepatitis C Notifications to Treatment in Tasmania
|
N/A | |
| Completed |
NCT03413696 -
Effects of Health Literacy and HCV Knowledge on HCV Treatment Willingness in HIV-coinfected Patients
|
||
| Completed |
NCT03109457 -
Hepatitis C Virus Detection in Oral Squamous Cell Carcinoma
|
||
| Completed |
NCT03118674 -
Harvoni Treatment Porphyria Cutanea Tarda
|
Phase 2 | |
| Completed |
NCT01458054 -
Effect of Omeprazole and Ritonavir on GSK2336805 Pharmacokinetics in Healthy Adults
|
Phase 1 | |
| Completed |
NCT03740230 -
An Observational Study of Maviret (Glecaprevir/Pibrentasvir) for Korean Chronic Hepatitis C Genotypes 1 to 6 Patients According to the Standard for Re-examination of New Drugs
|
||
| Completed |
NCT03426787 -
Helping Empower Liver and Kidney Patients
|
N/A | |
| Completed |
NCT03627299 -
Renal Transplants in Hepatitis C Negative Recipients With Nucleic Acid Positive Donors
|
Phase 4 | |
| Completed |
NCT00006301 -
Immune Response to Hepatitis C Virus
|
||
| Active, not recruiting |
NCT03949764 -
The Kentucky Viral Hepatitis Treatment Study
|
Phase 4 | |
| Completed |
NCT03365635 -
Administration of Zepatier (Grazoprevir Plus Elbasvir) in Chronic Hemodialysis (HD) Patients With Hepatitis C
|
Phase 4 | |
| Recruiting |
NCT04405024 -
Pilot Study on the Feasibility of Systematic Hepatitis C Screening of Hospitalized Patients
|
N/A | |
| Completed |
NCT04525690 -
Improving Inpatient Screening for Hepatitis C
|
N/A | |
| Completed |
NCT04033887 -
Evaluation Study of RDTs Detecting Antibodies Against HCV
|
||
| Withdrawn |
NCT04546802 -
HepATocellular Cancer Hcv Therapy Study
|
Phase 3 | |
| Active, not recruiting |
NCT02961426 -
Strategic Transformation of the Market of HCV Treatments
|
Phase 2/Phase 3 | |
| Completed |
NCT02683005 -
Study of Hepatitis C Treatment During Pregnancy
|
Phase 1 | |
| Completed |
NCT02869776 -
Integrating HCV and HIV Screening During the Era of HIV Antigen Testing
|
N/A | |
| Completed |
NCT02992184 -
PoC-HCV Genedrive Viral Detection Assay Validation Study
|
N/A |