UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039464 |
|---|---|
| Receipt number | R000044612 |
| Scientific Title | Effects of individual support plan using Management Tool for Daily Life Performance (MTDLP) at group-home for parson with mental illness. : Non-randomized multi-center clinical trial |
| Date of disclosure of the study information | 2020/04/01 |
| Last modified on | 2021/02/12 11:22:51 |
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Basic information
Public title
Effects of individual support plan using Management Tool for Daily Life Performance (MTDLP) at group-home for parson with mental illness. : Non-randomized multi-center clinical trial
Acronym
Effects of individual support plan using Management Tool for Daily Life Performance (MTDLP) at group-home for parson with mental illness. : Non-randomized multi-center clinical trial
Scientific Title
Effects of individual support plan using Management Tool for Daily Life Performance (MTDLP) at group-home for parson with mental illness. : Non-randomized multi-center clinical trial
Scientific Title:Acronym
Effects of individual support plan using Management Tool for Daily Life Performance (MTDLP) at group-home for parson with mental illness. : Non-randomized multi-center clinical trial
Region
| Japan |
Condition
Condition
mental illness
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to verify the effects of occupational therapists' interventions by Management Tool for Daily Life Performance (MTDLP) at group-home for mental illness.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Recovery Assessment Scale
Before and after six month intervention
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Management Tool for Daily Life Performance ; MTDLP(+)
Occupational Therapist ; OT(+)
Individual support plan(+)
6 months.
Interventions/Control_2
MTDLP(-)
OT(+)
Individual support plan(+)
6 months.
Interventions/Control_3
MTDLP(-)
OT(-)
Individual support plan(+)
6 months.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Those who are using group-home at the start of the intervention and who have a mental illness.
For research cooperative establishments, the main target is mental illness.
Key exclusion criteria
Not mental illness.
Those who have difficulty answering questionnaires.
Target sample size
72
Research contact person
Name of lead principal investigator
| 1st name | kazuhiro |
| Middle name | |
| Last name | SUZUKI |
Organization
Non-Profit Organization orangeheart
Division name
Nanngai(The Group home for mental illness)
Zip code
2070014
Address
5-45-7 Nangai, higashiyamato-shi, Tokyo-to 207-0014 Japan
TEL
0425626880
kazuhirosuzuki0313@gmail.com
Public contact
Name of contact person
| 1st name | kazuhiro |
| Middle name | |
| Last name | SUZUKI |
Organization
Non-Profit Organization orangeheart
Division name
Nanngai(The Group home for mental illness)
Zip code
207-0014
Address
5-45-7 Nangai, higashiyamato-shi, Tokyo-to 207-0014 Japan
TEL
0425626880
Homepage URL
kazuhirosuzuki0313@gmail.com
Sponsor or person
Institute
Non-Profit Organization orangeheart
Institute
Department
Personal name
Funding Source
Organization
Japan Association of Occupational Therapists.
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
N/A
Address
N/A
Tel
0425626880
kazuhirosuzuki0313@gmail.com
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
グループホームなんがい（東京）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 04 | Month | 01 | 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
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
No longer recruiting
Date of protocol fixation
| 2019 | Year | 12 | Month | 23 | Day |
Date of IRB
| 2019 | Year | 12 | Month | 23 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2021 | Year | 11 | Month | 30 | Day |
Date trial data considered complete
| 2021 | Year | 12 | Month | 15 | Day |
Date analysis concluded
| 2021 | Year | 12 | Month | 31 | Day |
Other
Other related information
The start has been delayed due to the covid-19.
Management information
Registered date
| 2020 | Year | 02 | Month | 12 | Day |
Last modified on
| 2021 | Year | 02 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044612
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
