UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000045282
Receipt number R000051721
Scientific Title Development of evidence-based occupational dysfunction support program utilizing latent rank theory
Date of disclosure of the study information 2021/09/01
Last modified on 2022/03/03 13:41:37

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Basic information

Public title

Development of evidence-based occupational dysfunction support program

Acronym

Single system design

Scientific Title

Development of evidence-based occupational dysfunction support program utilizing latent rank theory

Scientific Title:Acronym

Single system design

Region

Japan


Condition

Condition

Woker

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To build an evidence-based support program for healthcare professionals that addresses the severity of occupational dysfunction.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Occupational dysfunction

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Behavior,custom

Interventions/Control_1

Single System design

Interventions/Control_2


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

22 years-old <=

Age-upper limit

60 years-old >=

Gender

Male and Female

Key inclusion criteria

Persons above the cut-off value for occupational dysfunction
Those who have consented to this study

Key exclusion criteria

Persons below the cutoff value for occupational dysfunction
Those who did not agree with this study

Target sample size

3


Research contact person

Name of lead principal investigator

1st name Mutsumi
Middle name
Last name Teraoka

Organization

Kibi International University

Division name

Department of Occupational therapy

Zip code

7168508

Address

8, iga-cho, Takahashi

TEL

08029942233

Email

teraokam@kiui.ac.jp


Public contact

Name of contact person

1st name Mutsumi
Middle name
Last name Teraoka

Organization

Kibi International University

Division name

Department of Occupational therapy

Zip code

716-8508

Address

8, iga-cho, Takahashi

TEL

0866229454

Homepage URL


Email

teraokam@kiui.ac.jp


Sponsor or person

Institute

Kibi International University

Institute

Department

Personal name



Funding Source

Organization

Japan Science and Technology Agency

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Kibi International University

Address

8, iga-cho, Takahashi

Tel

0866229454

Email

teraokam@kiui.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 09 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

4

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

2021 Year 08 Month 30 Day

Date of IRB

2019 Year 12 Month 18 Day

Anticipated trial start date

2021 Year 08 Month 30 Day

Last follow-up date

2022 Year 02 Month 28 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2021 Year 08 Month 27 Day

Last modified on

2022 Year 03 Month 03 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051721