search
Back to results

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

Primary Purpose

Hepatitis C, Severe Mental Disorder

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Nursing monitoring program
As usual
Sponsored by
Hospital Regional de Malaga
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Hepatitis C focused on measuring Clinical Paths, Patient Care Planning, Hepatitis C, Severe Mental Disorders

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Regional Hospital of MálagaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

As usual

Nurse-Navigation Programme

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Changes in daily functioning
Changes in daily functioning, measured with Life Skill Profile (LSP) where a higher score means better daily functioning.
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
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.
Detection rate
% Detection after screening the severe mental disorder population

Full Information

First Posted
April 14, 2021
Last Updated
March 14, 2022
Sponsor
Hospital Regional de Malaga
Collaborators
University of Malaga, Gilead Sciences, Instituto de Investigacion Biomedica de Malaga
search

1. Study Identification

Unique Protocol Identification Number
NCT04891445
Brief Title
Hepatitis C in Severe Mental Disorders: Nursing Programme
Acronym
HEPASAME21
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

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2021 (Actual)
Primary Completion Date
May 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Regional de Malaga
Collaborators
University of Malaga, Gilead Sciences, Instituto de Investigacion Biomedica de Malaga

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C, Severe Mental Disorder
Keywords
Clinical Paths, Patient Care Planning, Hepatitis C, Severe Mental Disorders

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
276 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
As usual
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Nurse-Navigation Programme
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Nursing monitoring program
Other Intervention Name(s)
Clinical Path
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
As usual
Intervention Description
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.
Primary Outcome Measure Information:
Title
Healing
Description
% healing in both groups (measured as undetectable viral load in a blood test done 3 months after finishing treatment).
Time Frame
6 months
Title
Adherence
Description
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)
Time Frame
8-12 weeks
Secondary Outcome Measure Information:
Title
Changes in daily functioning
Description
Changes in daily functioning, measured with Life Skill Profile (LSP) where a higher score means better daily functioning.
Time Frame
6 months
Title
Negative symptoms
Description
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
Time Frame
6 months
Title
Changes in health related quality of life
Description
Health related quality of life is assessed by the European Quality of Life-5 Dimensions Questionnaire (EQ-5D). A higher score means better health.
Time Frame
6 months
Title
Detection rate
Description
% Detection after screening the severe mental disorder population
Time Frame
2 years
Other Pre-specified Outcome Measures:
Title
Characterization variable 1
Description
Age (in years)
Time Frame
At the beginning
Title
Characterization variable 2
Description
Sex (male / female)
Time Frame
At the beginning
Title
Characterization variable 3
Description
Type of diagnosis (classification according to DSM-IV)
Time Frame
At the beginning
Title
Characterization variable 4
Description
Disease evolution time (in months)
Time Frame
At the beginning
Title
Characterization variable 5
Description
Drug treatment (name and dose of all drugs)
Time Frame
At the beginning and if there are changes (6 months)
Title
Characterization variable 6
Description
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).
Time Frame
At the beginning and if there are changes (6 months)
Title
Characterization variable 7
Description
Number of admissions to a mental health hospitalization unit in the last 12 months.
Time Frame
At the beginning and if there are new hospital admission (6 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Casta Quemada
Phone
666558490
Email
castaquem@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
José Miguel Morales-Asencio
Phone
629776895
Email
casta.quemada.sspa@juntadeandalucia.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
María Magdalena Hurtado, PhD
Organizational Affiliation
Regional Hospital of Málaga, Spain.
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Celia Martí-García, PhD
Organizational Affiliation
Faculty of Health Sciences. University of Málaga, Spain
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
José Miguel Morales-Asencio, PhD
Organizational Affiliation
Faculty of Health Sciences. University of Málaga, Spain.
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Casta Quemada
Organizational Affiliation
Regional Hospital of Málaga, Spain.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Regional Hospital of Málaga
City
Málaga
State/Province
Malaga
ZIP/Postal Code
29009
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ANTONIO BORDALLO, DOCTOR
Phone
600156950
Email
usmclimonar.hch.sspa@juntadeandalucia.es

12. IPD Sharing Statement

Citations:
PubMed Identifier
35443727
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.
Results Reference
derived

Learn more about this trial

Hepatitis C in Severe Mental Disorders: Nursing Programme

We'll reach out to this number within 24 hrs