UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effectiveness of Information Technology Aided Relapse Prevention Program in Schizophrenia (ITAREPS)
Title of the study (Brief title)	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	Masaomi Iyo
Organization	Chiba University Graduate School of Medicine
Division name	Department of Psychiatry
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	Hideki Komatsu
Organization	Chiba University Graduate School of Medicine
Division name	Department of Psychiatry
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2009 Year 06 Month 17 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	http://www.schres-journal.com/article/S0920-9964(13)00442-8/abstract
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).
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