UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045392 |
|---|---|
| Receipt number | R000051834 |
| Scientific Title | The pilot study for the effect of intervention with Action Over Inertia (AOI)in Japanese version |
| Date of disclosure of the study information | 2021/10/01 |
| Last modified on | 2025/03/31 15:35:40 |
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Basic information
Public title
The pilot study for the effect of intervention with Action Over Inertia (AOI)in Japanese version
Acronym
AOI Japanese version: pilot study
Scientific Title
The pilot study for the effect of intervention with Action Over Inertia (AOI)in Japanese version
Scientific Title:Acronym
AOI Japanese version: pilot study
Region
| Japan |
Condition
Condition
People with serious mental illness (schizophrenia, mood disorder, developmental disorder, substance related disorders)
Classification by specialty
| Psychiatry | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Revealing the effectiveness of intervention with AOI compared with usual occupational therapy intervention.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase I
Assessment
Primary outcomes
OQ (Occupational Questionnaire)
(baseline/ 3 months later/ 6months later/ 9months later)
Key secondary outcomes
1.TUCPM (Temple University Community
Participation Measure)
2. AEM (Activity Engagement Measure):AOI Worksheet 2.10
3.GHQ-28(General Health Questionnarie-28)
4.RAS(Recovery Assessment Scale)
5. Perceived Devaluation Discrimination(PDD)
5. BPRS(Brief Psychiatric Rating Scale)
6. GAF(Global Assessment of Functioning)
7.dosage
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom | Other |
Interventions/Control_1
AOI intervention (once a week / 60 minutes / 6 months)
Interventions/Control_2
occupational therapy as usual (once a week / 60 minutes / 6 months)
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.people with serious mental illness defined by National Institute of Mental Health)
2.diagnosed with psychiatric disorder by DSM-5 or ICD-10
3.Using community service like day-care service etc.)
4.living in the community over 2 years
5. Under 6 score in Worksheet 1.2 included AOI textbook
6. consent to participate in this study
7. have permission of participate in his study by doctor in charge
Key exclusion criteria
1.Diagnosed with dementia
2.No Stabilization of Residence
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Aiko |
| Middle name | |
| Last name | Hoshino |
Organization
Graduate School of Medicine, Nagoya University
Division name
Occupational Therapy Sciences, Prevention & Rehabilitation Sciences Course, Division of Integrated Care Sciences Technology, Department of Integrated Health Sciences
Zip code
4618673
Address
1-1-20daiko-minami, higashiku, Nagoyashi
TEL
052-719-3176
hoshino@met.nagoa-u.ac.jp
Public contact
Name of contact person
| 1st name | Aiko |
| Middle name | |
| Last name | Hoshino |
Organization
Graduate School of Medicine, Nagoya University
Division name
Care Sciences Technology, Department of Integrated Health Sciences
Zip code
4618673
Address
1-1-20daiko-minami, higashiku, Nagoyashi
TEL
052-719-3176
Homepage URL
hoshino@met.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya university
Institute
Department
Personal name
Funding Source
Organization
Nagoya university research fellowship
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Research Ethics Committee of the Graduate School of Medicine, Nagoya University, Japan
Address
65, Tsurumaicho,Syo-waku, Nagoyashi
Tel
052-719-1504
ethics@med.nagoya-u.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
| 2021 | Year | 10 | Month | 01 | Day |
Related information
URL releasing protocol
https://nuss.nagoya-u.ac.jp/s/TyiLYKD5cRf9xwQ
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
30
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
As the data analysis is taking longer than expected.
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
No longer recruiting
Date of protocol fixation
| 2021 | Year | 07 | Month | 21 | Day |
Date of IRB
| 2021 | Year | 08 | Month | 06 | Day |
Anticipated trial start date
| 2021 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 09 | Month | 06 | Day |
Last modified on
| 2025 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051834
