UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000020568
Receipt number 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 22:58:10

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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 or person

Institute

Tsukuba International University

Institute

Department

Personal name



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

Value
https://center6.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