Clinical trial NCT04891445: Hepatitis C in Severe Mental Disorders: Nursing Programme
Official title: Efficacy of a Nursing Monitoring Program for Detection and Treatment of Hepatitis C in a Population With Severe Mental Disorder.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hepatitis C
Severe Mental Disorder
Keywords: Clinical Paths
Patient Care Planning
Hepatitis C
Severe Mental Disorders
Lead sponsor: Hospital Regional de Malaga
Sponsor class: OTHER
Collaborators: name: University of Malaga
name: Gilead Sciences
name: Instituto de Investigacion Biomedica de Malaga
First posted: 2021-05-18
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Healing
timeFrame: 6 months
measure: Adherence
timeFrame: 8-12 weeks
Secondary outcomes:
measure: Changes in daily functioning
timeFrame: 6 months
measure: Negative symptoms
timeFrame: 6 months
measure: Changes in health related quality of life
timeFrame: 6 months
measure: Detection rate
timeFrame: 2 years
Other outcomes:
measure: Characterization variable 1
timeFrame: At the beginning
measure: Characterization variable 2
timeFrame: At the beginning
measure: Characterization variable 3
timeFrame: At the beginning
measure: Characterization variable 4
timeFrame: At the beginning
measure: Characterization variable 5
timeFrame: At the beginning and if there are changes (6 months)
measure: Characterization variable 6
timeFrame: At the beginning and if there are changes (6 months)
measure: Characterization variable 7
timeFrame: At the beginning and if there are new hospital admission (6 months)
Locations:
city: Málaga
country: Spain
facility: Regional Hospital of Málaga
state: Malaga
Study officials:
affiliation: Regional Hospital of Málaga, Spain.
name: María Magdalena Hurtado, PhD
role: STUDY_CHAIR
affiliation: Faculty of Health Sciences. University of Málaga, Spain
name: Celia Martí-García, PhD
role: STUDY_CHAIR
affiliation: Faculty of Health Sciences. University of Málaga, Spain.
name: José Miguel Morales-Asencio, PhD
role: STUDY_DIRECTOR
affiliation: Regional Hospital of Málaga, Spain.
name: Casta Quemada
role: PRINCIPAL_INVESTIGATOR
References:
citation: Quemada-Gonzalez C, Morales-Asencio JM, Hurtado MM, Marti-Garcia C. Study protocol: a randomised, controlled trial of a nurse navigator program for the management of hepatitis C virus in patients with severe mental disorder. BMC Nurs. 2022 Apr 20;21(1):92. doi: 10.1186/s12912-022-00870-w.