UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024304 |
|---|---|
| Receipt number | 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 21:30:51 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
chibakomatsu@gmail.com
Sponsor or person
Institute
Chiba University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.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 |
