Hepatitis C in Severe Mental Disorders: Nursing Programme (HEPASAME21)

March 14, 2022 updated by: Casta Quemada-González, Hospital Regional de Malaga

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

276

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: As usual

Patients will be directly referred to their family doctor with a report on the data obtained in the analysis (presence of HCV and positive viral load), so that they can follow the usual treatment (as usual) in these cases in the Andalusian Health Service.

The usual treatment implies, once the presence of Virus C has been confirmed, referral by the patient's family doctor to the specialized service, in this case the Gastroenterology Service of the referral Hospital, through the usual appointment procedure. Generally the delay in this process is usually approx. 2-3 months for the first appointment.
Behavioral: 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.
Experimental: Nurse-Navigation Programme

A Clinical Pathway (CP) of nursing monitoring will be activated, that is, patients will be accompanied throughout the evaluation and treatment process until their complete cure is guaranteed.

CP will include the activation of care in the Gastroenterology Service by the nurse. By requesting a first appointment in the Gastroenterology Service, via email, the nurse will activate the patients' access to this first appointment, which consist in a one-step intervention: liver evaluation analysis on the genotype, determine the most appropriate type of treatment and, dispensing treatment by the Hospital Pharmacy Unit. To guarantee attendance, in all cases the patient will be accompanied, either by a competent available family caregiver, or by the mental health nursing team.

All the intervention will be operationalized through the mentioned CP developed for this purpose, with the participation of those involved.
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.
Other Names:
  • Clinical Path

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Healing
Time Frame: 6 months
% healing in both groups (measured as undetectable viral load in a blood test done 3 months after finishing treatment).
6 months
Adherence
Time Frame: 8-12 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in daily functioning
Time Frame: 6 months
Changes in daily functioning, measured with Life Skill Profile (LSP) where a higher score means better daily functioning.
6 months
Negative symptoms
Time Frame: 6 months
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
Changes in health related quality of life
Time Frame: 6 months
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
Detection rate
Time Frame: 2 years
% Detection after screening the severe mental disorder population
2 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Characterization variable 1
Time Frame: At the beginning
Age (in years)
At the beginning
Characterization variable 2
Time Frame: At the beginning
Sex (male / female)
At the beginning
Characterization variable 3
Time Frame: At the beginning
Type of diagnosis (classification according to DSM-IV)
At the beginning
Characterization variable 4
Time Frame: At the beginning
Disease evolution time (in months)
At the beginning
Characterization variable 5
Time Frame: At the beginning and if there are changes (6 months)
Drug treatment (name and dose of all drugs)
At the beginning and if there are changes (6 months)
Characterization variable 6
Time Frame: At the beginning and if there are changes (6 months)
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)
Characterization variable 7
Time Frame: At the beginning and if there are new hospital admission (6 months)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Regional de Malaga

Collaborators

Gilead Sciences
University of Malaga
Instituto de Investigacion Biomedica de Malaga

Investigators

  • Study Chair: María Magdalena Hurtado, PhD, Regional Hospital of Málaga, Spain.
  • Study Chair: Celia Martí-García, PhD, Faculty of Health Sciences. University of Málaga, Spain
  • Study Director: José Miguel Morales-Asencio, PhD, Faculty of Health Sciences. University of Málaga, Spain.
  • Principal Investigator: Casta Quemada, Regional Hospital of Málaga, Spain.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2021

Primary Completion (Anticipated)

May 31, 2023

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

April 14, 2021

First Submitted That Met QC Criteria

May 17, 2021

First Posted (Actual)

May 18, 2021

Study Record Updates

Last Update Posted (Actual)

March 29, 2022

Last Update Submitted That Met QC Criteria

March 14, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CQG-20 (0444-N-20)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hepatitis C

Clinical Trials on As usual

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Australia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe