Back to resultsA RCT Study in Schizophrenia Relapse Prevention
Primary Purpose
Relapse Schizophrenia
Status
Unknown status
Phase
Not Applicable
Locations
Czech Republic
Study Type
Interventional
Intervention
ITAREPS
Sponsored by
About this trial
This is an interventional prevention trial for Relapse Schizophrenia focused on measuring schizophrenia; relapse prevention; information technology
Eligibility Criteria
Inclusion Criteria:
For entry into the study, the following criteria MUST be met:
- Men and women, ages 18 to 60 years, inclusive.
- A diagnosis of schizophrenia or schizoaffective disorder according to ICD-10 classification.
- Having at least TWO psychiatric hospitalization for psychosis before the study enrollment.
- Severity (CGI-S) ≤ 3 at study Visit 1.
- All patients must be on stable doses of antipsychotic medication during the study entry.
Exclusion Criteria:
- Organic mental disorder,
- mental disorder due to psychoactive substance use or mental retardation.
- Participation in another relapse prevention program.
- Hayward compliance rating scale score < 2 at Visit 1.
Sites / Locations
- Prague Psychiatric Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
20% antisychotic dose increase in prodromes
Treatment as usual
Arm Description
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.
In the control group (treatment-as-usual) participants will not be enrolled in the ITAREPS system.
Outcomes
Primary Outcome Measures
Primary Objective: The hospitalization-free survival rate at 18 months in active group compared to the control group.
Secondary Outcome Measures
Number of psychiatric hospitalization days
Direct impatient costs
Direct cost of outpatient antipsychotic medication
Cumulative exposition to antipsychotic medication in both active ITAREPS and control groups
Full Information
NCT ID
NCT01885923
First Posted
August 14, 2012
Last Updated
July 10, 2013
Sponsor
Prague Psychiatric Center
1. Study Identification
Unique Protocol Identification Number
NCT01885923
Brief Title
A RCT Study in Schizophrenia Relapse Prevention
Official Title
Prospective, Randomized, Open, Controlled Study With Information and Telecommunication Technology-aided Relapse Prevention Program in Schizophrenia.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2013
Overall Recruitment Status
Unknown status
Study Start Date
August 2012 (undefined)
Primary Completion Date
July 2014 (Anticipated)
Study Completion Date
December 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Prague Psychiatric Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapse Schizophrenia
Keywords
schizophrenia; relapse prevention; information technology
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
20% antisychotic dose increase in prodromes
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Treatment as usual
Arm Type
No Intervention
Arm Description
In the control group (treatment-as-usual) participants will not be enrolled in the ITAREPS system.
Intervention Type
Device
Intervention Name(s)
ITAREPS
Other Intervention Name(s)
Information Technology Aided Relaps Prevention in Schizophrenia
Intervention Description
Program ITAREPS (Information Technology Aided Relaps Prevention in Schizophrenia)
Primary Outcome Measure Information:
Title
Primary Objective: The hospitalization-free survival rate at 18 months in active group compared to the control group.
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Number of psychiatric hospitalization days
Time Frame
18months
Title
Direct impatient costs
Time Frame
18months
Title
Direct cost of outpatient antipsychotic medication
Time Frame
18months
Title
Cumulative exposition to antipsychotic medication in both active ITAREPS and control groups
Time Frame
18months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
For entry into the study, the following criteria MUST be met:
Men and women, ages 18 to 60 years, inclusive.
A diagnosis of schizophrenia or schizoaffective disorder according to ICD-10 classification.
Having at least TWO psychiatric hospitalization for psychosis before the study enrollment.
Severity (CGI-S) ≤ 3 at study Visit 1.
All patients must be on stable doses of antipsychotic medication during the study entry.
Exclusion Criteria:
Organic mental disorder,
mental disorder due to psychoactive substance use or mental retardation.
Participation in another relapse prevention program.
Hayward compliance rating scale score < 2 at Visit 1.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Filip Spaniel, MD, PhD
Organizational Affiliation
Prague Psychiatric Center
Official's Role
Study Director
Facility Information:
Facility Name
Prague Psychiatric Center
City
Prague
ZIP/Postal Code
18103
Country
Czech Republic
12. IPD Sharing Statement
Citations:
PubMed Identifier
26176646
Citation
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.
Results Reference
derived
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A RCT Study in Schizophrenia Relapse Prevention
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