UMIN-CTR Clinical Trial

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