Hepatitis C in Severe Mental Disorders: Nursing Programme

NCT04891445 | Completed

• 1 other identifier: CQG-20 (0444-N-20)
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatitis C; Severe Mental Disorder

Keywords

Clinical Paths; Patient Care Planning; Hepatitis C; Severe Mental Disorders

Outcome Measures

Primary Outcomes (2)

• Healing

  % healing in both groups (measured as undetectable viral load in a blood test done 3 months after finishing treatment).

  6 months

• 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 Outcomes (4)

• Changes in daily functioning

  6 months

• Negative symptoms

  6 months

• Changes in health related quality of life

  6 months

• Detection rate

  2 years

Other Outcomes (7)

• Characterization variable 1

  At the beginning

• Characterization variable 2

  At the beginning

• Characterization variable 3

  At the beginning

Study Arms (2)

As usual

ACTIVE COMPARATOR

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

Nurse-Navigation Programme

EXPERIMENTAL

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

Interventions

Nursing monitoring program BEHAVIORAL

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.

Also known as: Clinical Path

Nurse-Navigation Programme

As usual BEHAVIORAL

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.

As usual

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Severe mental disorder
• Hepatitis C positive with viral load

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Regional de Malaga: lead
• University of Malaga: collaborator
• Gilead Sciences: collaborator
• Instituto de Investigacion Biomedica de Malaga: collaborator

Study Sites (1)

Regional Hospital of Málaga

Málaga, Malaga, 29009, Spain

Location

Related Publications (1)

• 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.

  PMID: 35443727 DERIVED

MeSH Terms

Conditions

Hepatitis C; Mental Disorders

Interventions

Critical Pathways

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Patient Care Planning; Comprehensive Health Care; Patient Care Management; Health Services Administration

Study Officials

• María Magdalena Hurtado, PhD

  Regional Hospital of Málaga, Spain.

  STUDY CHAIR

• Celia Martí-García, PhD

  Faculty of Health Sciences. University of Málaga, Spain

  STUDY CHAIR

• José Miguel Morales-Asencio, PhD

  Faculty of Health Sciences. University of Málaga, Spain.

  STUDY DIRECTOR

• Casta Quemada

  Regional Hospital of Málaga, Spain.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Mental Health Nursing

Study Record Dates

• First Submitted: April 14, 2021
• First Posted: May 18, 2021
• Study Start: June 1, 2021
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: October 22, 2024

Record last verified: 2024-10

Locations

ES (1)