Hepatitis C in Severe Mental Disorders: Nursing Programme
NCT ID: NCT04891445
Last Updated: 2024-10-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
16 participants
INTERVENTIONAL
2021-06-01
2023-12-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
SINGLE
Study Groups
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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.
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.
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.
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Hepatitis C positive with viral load
Exclusion Criteria
* Patients in a clear situation of psychopathological decompensation (until recovery)
* Patients does not agree to participate
18 Years
ALL
No
Sponsors
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University of Malaga
OTHER
Gilead Sciences
INDUSTRY
Instituto de Investigacion Biomedica de Malaga
OTHER
Hospital Regional de Malaga
OTHER
Responsible Party
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Casta Quemada-González
Mental Health Nursing
Principal Investigators
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María Magdalena Hurtado, PhD
Role: STUDY_CHAIR
Regional Hospital of Málaga, Spain.
Celia Martí-García, PhD
Role: STUDY_CHAIR
Faculty of Health Sciences. University of Málaga, Spain
José Miguel Morales-Asencio, PhD
Role: STUDY_DIRECTOR
Faculty of Health Sciences. University of Málaga, Spain.
Casta Quemada
Role: PRINCIPAL_INVESTIGATOR
Regional Hospital of Málaga, Spain.
Locations
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Regional Hospital of Málaga
Málaga, Malaga, Spain
Countries
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References
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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.
Other Identifiers
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CQG-20 (0444-N-20)
Identifier Type: -
Identifier Source: org_study_id
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