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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000020568
Receipt No. R000023747
Scientific Title Effectiveness evaluation for organize classes targeting young people with mild disorganization by Open-label, Randomized Controlled Trial.
Date of disclosure of the study information 2016/01/16
Last modified on 2019/10/01

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Basic information
Public title Effectiveness evaluation for organize classes targeting young people with mild disorganization by Open-label, Randomized Controlled Trial.
Acronym Study for the effectiveness of organize class.
Scientific Title Effectiveness evaluation for organize classes targeting young people with mild disorganization by Open-label, Randomized Controlled Trial.
Scientific Title:Acronym Study for the effectiveness of organize class.
Region
Japan

Condition
Condition People age between 12 to 55 with mild disorganization
Classification by specialty
Not applicable Adult Child
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evaluation for effectiveness of organize class
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The stress caused by messy state of her rooms at 6 months after class (Japanese version of the Saving Inventory-Revised).
Key secondary outcomes The stress caused by messy state of her rooms at1,3 months after class (Japanese version of the Saving Inventory-Revised),etc.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom Other
Interventions/Control_1 Four consecutive classes to learn how to get organized and one time organize service offered by professional organizers
Interventions/Control_2 One time organize service offered by professional organizers only
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
12 years-old <=
Age-upper limit
55 years-old >
Gender Male and Female
Key inclusion criteria 1 People who are not good at keeping their room tidy
2 People who are scored over 30 points on the SIR
3 People who are scored over 4 points on the total CIR
4 People who are able to organize their rooms themselves
5 People who have no plan of moving or renovation
6 People who can attend organize class more than three times and are willing to accept professional organize service.
7 People who are motivated to get organized
8 People who can send their reports back regularly
9 People who can get consent from parents or guardian
Key exclusion criteria 1 Those with disorganization due to mental disease or physical handicap.
Those with hoarding disorder
Those who don't live in the room.
2 Those who are incorporative or who do not follow the rules in the classes.
3 Those who don't turn in their reports
4 Those who was judged to be inappropriate as a subject by doctor in charge
5 Those who are considered to be inappropriate for the research.
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Aso Yasuko
Organization Tsukuba International University
Division name Department of Nursing, Faculty of Health Sciences
Zip code
Address 6-8-33 Manabe, Tsuchiura, Ibaraki
TEL 029-883-6003
Email y-asou@tius.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Aso Yasuko
Organization Tsukuba International University
Division name Department of Nursing, Faculty of Health Sciences
Zip code
Address 6-8-33 Manabe, Tsuchiura, Ibaraki
TEL 029-883-6003
Homepage URL
Email y-asou@tius.ac.jp

Sponsor
Institute Tsukuba International University
Institute
Department

Funding Source
Organization The Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor Teikyo University Graduate School of Public Health
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 帝京大学

Other administrative information
Date of disclosure of the study information
2016 Year 01 Month 16 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled 61
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
2015 Year 11 Month 25 Day
Date of IRB
Anticipated trial start date
2016 Year 01 Month 16 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 01 Month 14 Day
Last modified on
2019 Year 10 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023747

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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