Study With Information Technology (IT) - Aided Preventive Program in Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional

Summary: 
      Information Technology-aided Program of Relapse Prevention in Schizophrenia (ITAREPS) will
      decrease the number of hospitalizations in patients with schizophrenia or schizoaffective
      disorder who are treated in the outpatient psychiatric setting, as evidenced by the reduction
      of the total number of hospitalizations due to relapse of psychosis at the end of the
      12-months follow-up period in the active ITAREPS group compared to the control
      (treatment-as-usual) group.
    

Detailed description: 
      Title of Study:

      ITAREPS Trial: A Prospective Randomized Double-blind Controlled Study in IT-aided Mobile
      Phone-based Relapse Prevention Program in Schizophrenia.

      Estimated Number of Study Centers and Countries:

      30-40 outpatient psychiatrists in the Czech Republic and in the Slovak Republic.

      Research Hypothesis:

      Information Technology-aided Program of Relapse Prevention in Schizophrenia (ITAREPS) will
      decrease the number of hospitalizations in patients with schizophrenia or schizoaffective
      disorder who are treated in the outpatient psychiatric setting, as evidenced by the reduction
      of the total number of hospitalizations due to relapse of psychosis at the end of the
      12-months follow-up period in the active ITAREPS group compared to the control
      (treatment-as-usual) group.

      Study Phase:

      Non Drug Interventional Study

      Study Objective:

      To evaluate effectiveness of the ITAREPS program in reduction of the number of
      hospitalizations due to relapse of psychosis. The ITAREPS program employs mobile phone
      communication between the psychiatrist and the patient. Subjects enrolled in the project
      (patient and his/her family member) are instructed to complete two separate versions of the
      10-item Early Warning Signs Questionnaire (EWSQ) upon a weekly SMS request sent automatically
      by the system. EWSQ detects proportional worsening (or a new onset) of psychotic symptoms
      compared to the last week's score of the completed questionnaire. Individual EWSQ scores are
      sent by the subjects back to the ITAREPS system as a SMS text message. If the EWSQ score
      exceeds given score thresholds, an immediate ALERT requesting a therapeutic intervention is
      announced to the investigator as an e-mail message and a timely pharmacological intervention
      is triggered in accordance with the Early Intervention Algorithm (EIA).

      Study design:

      This is an international, randomized, double-blind, controlled, design-blinded, non drug,
      interventional study. Subjects (patient and family member pairs) will be randomized at a 1:1
      ratio into the interventional or control group. All subjects will complete the EWSQ on a
      weekly basis. In the interventional group, e-mail alert message feedback to the investigator
      will be active and the investigator will react by using the EIA. In the control
      (treatment-as-usual) group, alerts will not be generated and the investigator will detect and
      react on the potential signs of the psychotic relapse only by using the standard clinical
      approach. The ALERTs will be reported to the investigators in approximately 50% of all ALERT
      events but the investigators and subjects will be kept blinded about the real study design -
      parallel or (multiple) cross-over. The type of the study design is specified only in section
      3.1.1. of the protocol. This section will not be available to the investigators and will be
      provided only for the purpose of the regulatory and ethics review.

      Study duration: 12 months

      Number of subjects:

      150 enrolled patient/family member pairs (i.e. 300 subjects) resulting in expected 120
      evaluable patient/family member pairs (i.e. 240 subjects) will be participating in the study.

      Study population:

      Male and female patients between 18 to 60 having ICD-10 diagnosis of schizophrenia or
      schizoaffective disorder and their healthy family members, both eligible for mobile phone
      communicating.

      Statistical Methods:

      The primary effectiveness analysis will be a comparison of the upper bound of 95% confidence
      interval (CI) for the mean number of hospitalizations in patients in the active ITAREPS group
      at month 12 compared to the control (treatment-as-usual) group. Rehospitalization risk will
      be analyzed using Kaplan-Meier survival analysis in both groups. An interim analysis
      evaluating the between group differences in the number of psychiatric hospitalization days
      will be performed after all enrolled patients have completed their Visit 2 (month 6).
    

Intervention name(s): antipsychotic dose increase; no intervention
Intervention type(s): Drug; Other
Intervention description(s): 20% increase in the dose of current antipsychotic medication; Treatment as usual
Other intervention name(s): All antipsychotics approved for clinical use in Czech and Slovak Republic:; Treatment as usual
Intervention MeSH terms: Antipsychotic Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: prevention; relapse; schizophrenia