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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024304
Receipt No. R000027974
Scientific Title Effectiveness of Information Technology Aided Relapse Prevention Program in Schizophrenia (ITAREPS)
Date of disclosure of the study information 2016/10/05
Last modified on 2016/10/05

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Basic information
Public title Effectiveness of Information Technology Aided Relapse Prevention Program in Schizophrenia (ITAREPS)
Acronym Effectiveness of Information Technology Aided Relapse Prevention Program in Schizophrenia (ITAREPS)
Scientific Title Effectiveness of Information Technology Aided Relapse Prevention Program in Schizophrenia (ITAREPS)
Scientific Title:Acronym Effectiveness of Information Technology Aided Relapse Prevention Program in Schizophrenia (ITAREPS)
Region
Japan

Condition
Condition Schizophrenia
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 to evaluate the effectiveness of Information Technology Aided Relapse Prevention Program in Schizophrenia (ITAREPS)
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Phase II,III

Assessment
Primary outcomes the number of rehospitalizations, the number of rehospitalization days, the number of relapse during the 12 months
Key secondary outcomes changes in the total Brief Psychiatric Rating Scale (BPRS) score at the time of rehospitalization and relapse after the start of the trial

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as a block.
Blocking YES
Concealment Pseudo-randomization

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Medicine Device,equipment Behavior,custom
Maneuver
Interventions/Control_1 Outpatient treatment and visiting nursing care with Information Technology Aided Relapse Prevention Program (ITAREPS)
Interventions/Control_2 Outpatient treatment and visiting nursing care as usual
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
65 years-old >
Gender Male and Female
Key inclusion criteria Diagnosed with schizophrenia defined by the Diagnostic and Statistical Manual of Mental Health Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria
Having a landline or mobile phone
Having hospitalization for the past three years
Having a caregiver
Providing an written informed consent
Key exclusion criteria Having a history of other mental illnesses or complication
Organic brain disease
Serious physical illness
Diagnosed by a doctor to be at risk of suicide at Providing informed consent
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masaomi Iyo
Organization Chiba University Graduate School of Medicine
Division name Department of Psychiatry
Zip code
Address 1-8-1 Inohana, Chuou-ku, Chiba, Japan
TEL +81(0)432262148
Email iyom@faculty.chiba-u.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hideki Komatsu
Organization Chiba University Graduate School of Medicine
Division name Department of Psychiatry
Zip code
Address 1-8-1 Inohana, Chuou-ku, Chiba, Japan
TEL +81(0)432262148
Homepage URL
Email chibakomatsu@gmail.com

Sponsor
Institute Chiba University Graduate School of Medicine
Institute
Department

Funding Source
Organization Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2016 Year 10 Month 05 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://www.schres-journal.com/article/S0920-9964(13)00442-8/abstract
Number of participants that the trial has enrolled
Results
The risk of rehospitalization was reduced in the ITAREPS group compared with the control group (hazard ratio=0.21, number needed to treat (NNT)=4). 
The mean number of inpatient days was significantly lower in the ITAREPS group (18.5days) compared with the control group (88.8days) (p=0.036). 
The ratio of the number of rehospitalizations to that of relapses was significantly lower (p=0.035) and the mean change in total BPRS scores at relapse from baseline was significantly less in the ITAREPS group (p=0.019).
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2009 Year 06 Month 17 Day
Date of IRB
Anticipated trial start date
2009 Year 07 Month 01 Day
Last follow-up date
2011 Year 04 Month 27 Day
Date of closure to data entry
2011 Year 04 Month 27 Day
Date trial data considered complete
2011 Year 07 Month 27 Day
Date analysis concluded
2011 Year 09 Month 06 Day

Other
Other related information

Management information
Registered date
2016 Year 10 Month 05 Day
Last modified on
2016 Year 10 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027974

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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