UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035131 |
|---|---|
| Receipt number | R000040043 |
| Scientific Title | Prospective observational study on factors associated with personal recovery for inpatients with psychotic disorders |
| Date of disclosure of the study information | 2019/01/07 |
| Last modified on | 2019/12/13 11:37:08 |
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Basic information
Public title
Prospective observational study on factors associated with personal recovery for inpatients with psychotic disorders
Acronym
Prospective observational study on factors associated with personal recovery for inpatients with psychotic disorders
Scientific Title
Prospective observational study on factors associated with personal recovery for inpatients with psychotic disorders
Scientific Title:Acronym
Prospective observational study on factors associated with personal recovery for inpatients with psychotic disorders
Region
| Japan |
Condition
Condition
psychotic disorders
Classification by specialty
| Psychiatry | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To measure the change of indices of personal recovery among inpatients with psychotic disorders using four scales as main outcomes and to investigate relating factors with those.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Recovery Assessment Scale 24 (RAS)
Self-Identified stage of recovery Part-A(SISR-A)
Self-Identified stage of recovery Part-B (SISR-B)
Questionnaire about the Process of Recovery(QPR-J
Key secondary outcomes
Recovery Assessment Scale 24 (RAS)
Self-Identified stage of recovery Part-A(SISR-A)
Self-Identified stage of recovery Part-B (SISR-B)
Questionnaire about the Process of Recovery(QPR-J)
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 16 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with schizophrenia spectrum and other psychotic disorders such as delusional disorder, brief psychotic disorder, schizophreniform disorder, schizophrenia, or schizoaffective disorder including those in remission of psychotic episode diagnosed using DSM-5 who are hospitalized in psychiatric wards at recruitment in the study.
Key exclusion criteria
Those who (1) have severe physical symptoms precluding the participation to the research, (2) are not able to comprehend speech in Japanese, (3) have psychotic disorders induced by substance use or medication, (4)with neurocognitive disorders, (5) are judged by doctors in charge not to have the sufficient ability to judge the matters, (6) are under compulsory admission by the power of local government"Sochi-nyuin"(7) are isolated or physically bound at the bed, or (8) are going to transfer to other hospitals
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Norika |
| Middle name | |
| Last name | Mitsunaga |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Psychiatric Nursing
Zip code
9800875
Address
2-1,Seiryo-machi, Aoba-Ku, Sendai, 980-8575, Japan
TEL
0227177916
mitsuanga@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Norika |
| Middle name | |
| Last name | Mitsunaga |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Psychiatric Nursing
Zip code
9808574
Address
2-1,Seiryo-machi, Aoba-Ku, Sendai, 980-8575, Japan
TEL
022-717-7916
Homepage URL
mitsuanga@med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tohoku University Graduate School of Medicine
Address
2-1,Seiryo-machi, Aoba-Ku, Sendai, 980-8575, Japan
Tel
0227177916
mitsunaga@med.tohoku.ac.jp
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
| 2019 | Year | 01 | Month | 07 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
40
Results
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
| 2018 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 11 | Month | 26 | Day |
Anticipated trial start date
| 2019 | Year | 01 | Month | 16 | Day |
Last follow-up date
| 2020 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To measure the change of indices of personal recovery among inpatients with psychotic disorders using four scales as main outcomes and to investigate relating factors with those. Primari outcomes are Recovery Assessment Scale 24 (RAS), Self-Identified stage of recovery Part-A(SISR-A), Self-Identified stage of recovery Part-B (SISR-B), Questionnaire about the Process of Recovery(QPR-J). Key secondary outcoms are PANSS: positive and negative syndrome scale)General Self-Efficacy Scale (GSES)Rosenberg Self Esteem Scale(RSES)Client Satisfaction Questionnaire (CSQ)-8.
Management information
Registered date
| 2018 | Year | 12 | Month | 04 | Day |
Last modified on
| 2019 | Year | 12 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040043
