Hepatitis C in Severe Mental Disorders: Nursing Programme

Hepatitis C Clinical Trial

— HEPASAME21  

Official title:

Efficacy of a Nursing Monitoring Program for Detection and Treatment of Hepatitis C in a Population With Severe Mental Disorder.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04891445
• Other study ID #: CQG-20 (0444-N-20)
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: March 2022
• Source: Hospital Regional de Malaga
• Contact: Casta Quemada
• Phone: 666558490
• Email: castaquem[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Disease
• Hepatitis
• Hepatitis A
• Hepatitis C
• Mental Disorders
• Psychotic Disorders
• Severe Mental Disorder

Intervention

Behavioral:
• Nursing monitoring program
A clinical pathway will be activate that allows all the necessary interventions, once the person is diagnosed, to be carried out on the same day, and a mental health nursing team will monitor the entire process.
• As usual
Referral to the family doctor for a request for follow-up by the gastroenterologist. The specialist prescribes the tests for the definitive diagnosis that will take place in other units (with their corresponding appointments). After this, the patient will return to the specialist to establish the treatment to follow. Pharmacological treatment will be dispensed at the hospital pharmacy (collected once a month until completion of treatment and confirmation of cure). This last step of the treatment will be done in a new consultation at the gastroenterology service after blood tests to verify the disappearance of the viral load.

Locations

Country	Name	City	State
Spain	Regional Hospital of Málaga	Málaga	Malaga

Sponsors (4)

Lead Sponsor	Collaborator
Hospital Regional de Malaga	Gilead Sciences, Instituto de Investigación Biomédica de Málaga (IBIMA)., University of Malaga

Country where clinical trial is conducted

Spain, 

Outcome

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