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| ID | Type | Description | Link |
|---|---|---|---|
| NT/13292 - 3 | Registry Identifier | NT/13292 - 3 |
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THE AIM OF THE PROJECT The main aim lies in the prevention of frequent relapses typical for schizophrenia and schizoaffective disorder by means of simple, highly cost-effective information technology-aided approach RESEARCH HYPOTHESIS A the end of 18 months study duration, patients in the active group enrolled in ITAREPS will demonstrate statistically significantly reduced risk of hospitalization, decreased number of hospitalization days and reduced direct inpatient costs in comparison to control group not using the program.
The ITAREPS 2.0 program employs telecommunication and information technologies in order to detect fluctuations in longitudinal mental health status of patient with schizophrenia and thus signalize the very early stages of prodromes preceding relapse. This approach opens an avenue towards early pharmacological intervention. Subjects (150 patients with diagnosis of schizophrenia and schizoaffective disorder and their family members) will be randomized at a 1:1 ratio into the active or control group. Participants from the active group will be completing two separate versions of the 10-item Early Warning Signs Questionnaire (EWSQ) upon a weekly SMS request generated automatically by the system during 18 months study duration. In this group, automatically generated e-mail alert message feedback to the investigator will be activated in case of prodrome detection, prompting investigator to antipsychotic dose increase by 20%. The control (treatment-as-usual) group will not use ITAREPS system.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 20% antisychotic dose increase in prodromes | Active Comparator | Antipsychotic dose increase upon prodromes occurence detected by Device- ITAREPS system. All antipsychotics currently registered in Czech Republic will be allowed in this study. All patients will remain on antipsychotic treatment adjusted prior enrollment, so that dose adjustment will be based on their ordinary medication. Participants will be instructed to complete the 10-item EWS Questionnaire upon SMS request sent automatically weekly to their mobile phones. EWSQ detects proportional worsening of the symptoms compared to the last week's score of the questionnaire. Individual EWSQ scores will be sent by participants back to the ITAREPS system as a SMS. If the total score exceeds the given score threshold, an immediate ALERT would be declared and announced to the investigator as an e-mail message and a therapeutic intervention is requested. After detecting the early warning signs by ITAREPS, an immediate 20% increase in the dose of antipsychotic will be required. |
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| Treatment as usual | No Intervention | In the control group (treatment-as-usual) participants will not be enrolled in the ITAREPS system. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ITAREPS | Device | Program ITAREPS (Information Technology Aided Relaps Prevention in Schizophrenia) |
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| Measure | Description | Time Frame |
|---|---|---|
| Primary Objective: The hospitalization-free survival rate at 18 months in active group compared to the control group. | 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of psychiatric hospitalization days | 18months | |
| Direct impatient costs | 18months | |
| Direct cost of outpatient antipsychotic medication |
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Inclusion Criteria:
For entry into the study, the following criteria MUST be met:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Filip Spaniel, MD, PhD | Prague Psychiatric Center | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Prague Psychiatric Center | Prague | 18103 | Czechia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26176646 | Derived | Spaniel F, Novak T, Bankovska Motlova L, Capkova J, Slovakova A, Trancik P, Matejka M, Hoschl C. Psychiatrist's adherence: a new factor in relapse prevention of schizophrenia. A randomized controlled study on relapse control through telemedicine system. J Psychiatr Ment Health Nurs. 2015 Dec;22(10):811-20. doi: 10.1111/jpm.12251. Epub 2015 Jul 14. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | May 14, 2015 | |
| Reset | May 29, 2015 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 14, 2015 | May 29, 2015 |
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| 18months |
| Cumulative exposition to antipsychotic medication in both active ITAREPS and control groups | 18months |