UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000049411
Receipt number R000056222
Scientific Title Development of digital recording systems to evaluate the necessity and the appropriate selection of public health nursing practices
Date of disclosure of the study information 2022/12/01
Last modified on 2023/05/08 10:55:59

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Basic information

Public title

Development of digital recording systems to evaluate the necessity and the appropriate selection of public health nursing practices

Acronym

Development of digital recording systems to evaluate the necessity and the appropriate selection of public health nursing practices

Scientific Title

Development of digital recording systems to evaluate the necessity and the appropriate selection of public health nursing practices

Scientific Title:Acronym

Development of digital recording systems to evaluate the necessity and the appropriate selection of public health nursing practices

Region

Japan


Condition

Condition

Not applicable

Classification by specialty

Not applicable

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To examine the item validity of the public health nurses' activity record

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Necessity of public health nurse activities

Key secondary outcomes



Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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

18 years-old <=

Age-upper limit

75 years-old >

Gender

Male and Female

Key inclusion criteria

supervisory public health nurses
mid-career public health nurses

Key exclusion criteria

Those who have already responded to the pilot survey

Target sample size

1000


Research contact person

Name of lead principal investigator

1st name Kyoko
Middle name
Last name Yoshioka-Maeda

Organization

The University of Tokyo

Division name

Graduate School of Medicine

Zip code

1130033

Address

Hongo7-3-1 Bunkyo-ku, Tokyo, Japan

TEL

03-5841-3597

Email

kyokoy-tky@g.ecc.u-tokyo.ac.jp


Public contact

Name of contact person

1st name Hiroshige
Middle name
Last name Matsumoto

Organization

The University of Tokyo

Division name

Graduate School of Medicine

Zip code

1130033

Address

Hongo7-3-1 Bunkyo-ku, Tokyo, Japan

TEL

03-5841-3597

Homepage URL


Email

hiroshige-tky@g.ecc.u-tokyo.ac.jp


Sponsor or person

Institute

The University of Tokyo

Institute

Department

Personal name



Funding Source

Organization

Ministry of Health, Labour and Welfare

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

The University of Tokyo, Clinical Research Review Board

Address

Hongo7-3-1 Bunkyo-ku, Tokyo, Japan

Tel

03-5841-0818

Email

ethics@m.u-tokyo.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

2022 Year 12 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

573

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

No longer recruiting

Date of protocol fixation

2022 Year 12 Month 01 Day

Date of IRB

2022 Year 07 Month 20 Day

Anticipated trial start date

2022 Year 12 Month 01 Day

Last follow-up date

2023 Year 01 Month 13 Day

Date of closure to data entry

2023 Year 01 Month 13 Day

Date trial data considered complete

2023 Year 01 Month 31 Day

Date analysis concluded



Other

Other related information

Municipal public health nurses will be asked to fill in the activity record items and enter their subjective level of need for the cases with high and low necessity among (1) individual support, (2) district activities, and (3) projects for which they are in charge. The importance and readability of each item will also be investigated.


Management information

Registered date

2022 Year 11 Month 02 Day

Last modified on

2023 Year 05 Month 08 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056222


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name