Scale Validation Study for Prediction of Relapse and Short Term Rehospitalization in Patients With Schizophrenia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to establish and validate a scale/model that can be used to evaluate the duration of time and factors between short term hospital treatment and subsequent relapse periods in patients with schizoaffective/schizophreniform disorders.

Detailed Description
-----------------
This is an epidemiological (study of the distribution and determinants of health-related states or events in defined population), multicenter (study conducted at multiple sites), observational (study in which patients are observed), cross-sectional (observation of all patients at one specific point in time), prospective (in which the patients are first identified and then followed forward as time passes) study. The sources of information in the study are units medical short stay psychiatric hospitalization or the acute care of the whole country, and clinical data of the patient at discharge. No intervention will be provided in this study. The general data (age range, gender, highest level of educational attainment, level of family support, substance abuse, events stressors, type of schizophrenia according to DSM-IV criteria [Diagnostic and Statistical Manual fourth], etc) of approximately 2000 schizophrenia and schizoaffective disorder / schizophreniform patients will be collected in this study. No special tests will be done during the study. The study will collect patients' data in electronic data collection workbook and model validation will be used at 6 and 12 months to confirm no relapse / hospitalization. The study observation period corresponds to the 3 years preceding the current relapse and current income (current hospitalization period) and 12 months after admission.

Official Title
-----------------
Scale Validation of Prediction of Relapse and Rehospitalization Short Term in Patients With Schizophrenia

Conditions
-----------------
Schizophrenia

Intervention / Treatment
-----------------
* Other: No intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with Schizophrenia or Schizoaffective disorder of more than 2 years evolution and who find themselves admitted in a Short-Term Psychiatric Hospitalization Unit or Acute Unit Exclusion Criteria: Other patients with a psychiatric pathology different to schizophrenia, schizoaffective/schizophreniform disorders Patients with schizophrenia or schizoaffective/schizophreniform disorders of 2 years, or less evolution Pregnant, lactating, or planning to become pregnant within the next 12 months

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with Schizophrenia<br> | Other: No intervention<br>* This is an observational study. The data will be collected of patients suffering from schizophrenia and schizoaffective disorder / schizophreniform.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to short-term relapse | Time to early relapse of patients discharged from a short-stay psychiatric hospitalisation unit. | Up to 12 months | 
| Number of readmission of patients | Readmission in short-stay psychiatric hospital units when the schizophrenia or schizoaffective or schizophreniform disorder relapse. | Up to 12 months | 
| Clinical Global Impression - Severity (CGI-S) Score | The CGI-S rating scale is used to rate the severity of a patient's psychotic condition on a 7-point scale. It is rated as follows: 1=Normal, not at all ill, 2=Borderline mentally ill, 3=Mildly ill, 4=Moderately ill, 5=Markedly ill, 6=Severely ill, and 7=Among the most extremely ill. Higher scores indicate worsening. | Up to 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of disease |  | Within 3 years before the study start | 
| Drug abuse |  | Within 3 years before the study start | 
| Psychiatric diagnosis | Patients diagnosed with Schizophrenia or Schizoaffective/schizophreniform disorder. | Within 3 years before the study start | 
| Previous stress or event |  | Within 3 years before the study start | 
| Hospitalizations in the previous 3 years |  | Within 3 years before the study start | 
| Adherence to the psychiatric treatment |  | Within 3 years before the study start | 
| Previous pharmacological treatment |  | Within 3 years before the study start | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Relapse, Short Term Hospitalization, PRE-COG, RISSCH4075, Schizophrenia, Mental disorder, Schizoaffective disorder, Schizophreniform disorder, Epidemiological study, Scale validation