UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000045284
Receipt number R000051722
Scientific Title Health education action research for the residents in Mibu-town
Date of disclosure of the study information 2021/09/01
Last modified on 2023/08/28 14:08:47

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Basic information

Public title

Health education action research for the residents in Mibu-town

Acronym

Health education action research for the residents in Mibu-town

Scientific Title

Health education action research for the residents in Mibu-town

Scientific Title:Acronym

Health education action research for the residents in Mibu-town

Region

Japan


Condition

Condition

Toileting problem

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To conduct health education activity and evaluate its effect

Basic objectives2

Others

Basic objectives -Others

Health education activity will be conducted to improve toileting status

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Satisfaction with toileting, status of toileting

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Other

Interventions/Control_1

1-day health education activity

Interventions/Control_2

No health education activity

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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Being welfare commissioner

Key exclusion criteria

None

Target sample size

80


Research contact person

Name of lead principal investigator

1st name Gen
Middle name
Last name Kobashi

Organization

Dokkyo Medical University

Division name

Department of Public Health

Zip code

321-0293

Address

880 Kitakobayashi, Mibu-machi, Shimotsuga-gun, Tochigi

TEL

0282-87-2133

Email

gk-dph@dokkyomed.ac.jp


Public contact

Name of contact person

1st name Kyo
Middle name
Last name Takahashi

Organization

Dokkyo Medical University

Division name

Department of Public Health

Zip code

321-0293

Address

880 Kitakobayashi, Mibu-machi, Shimotsuga-gun, Tochigi

TEL

0282-87-2133

Homepage URL


Email

k-tak@dokkyomed.ac.jp


Sponsor or person

Institute

Dokkyo Medical University

Institute

Department

Personal name



Funding Source

Organization

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


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Dokkyo Medical University

Address

880 Kitakobayashi, Mibu-machi, Shimotsuga-gun, Tochigi

Tel

0282-86-1111

Email

soumu@dokkyomed.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

20

Results


Results date posted


Results Delayed

Delay expected

Results Delay Reason

To add more data

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 20 Day

Date of IRB

2021 Year 10 Month 14 Day

Anticipated trial start date

2021 Year 11 Month 17 Day

Last follow-up date

2023 Year 03 Month 31 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

2023 Year 08 Month 28 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051722