Hepatitis C Clinical Trial
— HEPASAME21Official 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.
Status | Recruiting |
Enrollment | 276 |
Est. completion date | December 31, 2023 |
Est. primary completion date | May 31, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Severe mental disorder - Hepatitis C positive with viral load Exclusion Criteria: - Patients who have contraindicated HCV treatment for any reason - Patients in a clear situation of psychopathological decompensation (until recovery) - Patients does not agree to participate |
Country | Name | City | State |
---|---|---|---|
Spain | Regional Hospital of Málaga | Málaga | Malaga |
Lead Sponsor | Collaborator |
---|---|
Hospital Regional de Malaga | Gilead Sciences, Instituto de Investigación Biomédica de Málaga (IBIMA)., University of Malaga |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Characterization variable 1 | Age (in years) | At the beginning | |
Other | Characterization variable 2 | Sex (male / female) | At the beginning | |
Other | Characterization variable 3 | Type of diagnosis (classification according to DSM-IV) | At the beginning | |
Other | Characterization variable 4 | Disease evolution time (in months) | At the beginning | |
Other | Characterization variable 5 | Drug treatment (name and dose of all drugs) | At the beginning and if there are changes (6 months) | |
Other | Characterization variable 6 | Physical comorbidities according to the list of physical diseases proposed by Diederichs et al. (2011) (cancer, diabetes mellitus, hypertension, myocardial infarction, chronic ischemic heart disease, cardiac arrhythmias, heart failure, cerebrovascular accident, chronic obstructive pulmonary disease and arthritis). | At the beginning and if there are changes (6 months) | |
Other | Characterization variable 7 | Number of admissions to a mental health hospitalization unit in the last 12 months. | At the beginning and if there are new hospital admission (6 months) | |
Primary | Healing | % healing in both groups (measured as undetectable viral load in a blood test done 3 months after finishing treatment). | 6 months | |
Primary | Adherence | Adherence to treatment in both groups using AIDS Clinical Trials Group method (medications not taken in a period of 4 days prior to the interview: % adherence = (total galenic units prescribed for that period - total units not taken) / total galenic units prescribed for that period) | 8-12 weeks | |
Secondary | Changes in daily functioning | Changes in daily functioning, measured with Life Skill Profile (LSP) where a higher score means better daily functioning. | 6 months | |
Secondary | Negative symptoms | Negative symptoms, measured with Positive and Negative Syndrome Scale PANSS, with 30 items that are scored from 1-absent to extreme 7 symptoms where a higher score indicates greater severity of symptoms | 6 months | |
Secondary | Changes in health related quality of life | Health related quality of life is assessed by the European Quality of Life-5 Dimensions Questionnaire (EQ-5D). A higher score means better health. | 6 months | |
Secondary | Detection rate | % Detection after screening the severe mental disorder population | 2 years |
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