UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000039777
Receipt number R000043405
Scientific Title Study on home care
Date of disclosure of the study information 2020/03/12
Last modified on 2020/03/11 20:04:26

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Basic information

Public title

Study on home care

Acronym

Study on home care

Scientific Title

Study on home care

Scientific Title:Acronym

Study on home care

Region

Japan


Condition

Condition

End-of-life care

Classification by specialty

Not applicable

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Clarify whether it is possible to enable or disable home-based nursing.

Basic objectives2

Others

Basic objectives -Others

Create a home-based nursing score by quantifying it.

Trial characteristics_1

Others

Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

Home care or hospital care

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

1 years-old <=

Age-upper limit

120 years-old >=

Gender

Male and Female

Key inclusion criteria

Those who meet all the requirements of 1 to 4 home-care patients who participate during the registration period
1 receiving medical care
2 Prognosis is diagnosed within 6 months
(3) Cannot be taken orally (including those with a high possibility of aspiration)
4 Central parenteral or tube feeding is not used (but high-calorie infusion is possible even if the route is secured)

Key exclusion criteria

Those who do not meet any of the requirements 1 to 4 above

Target sample size

100


Research contact person

Name of lead principal investigator

1st name Yoshiro
Middle name
Last name Suzuki

Organization

Medical Corporation Himawari association

Division name

Hiyoko Clinic

Zip code

223-0062

Address

1-20-16 Hiyoshihoncho kohoku-ward. Yokohama Japan

TEL

045-563-4115

Email

ys.himawarikai@gmail.com


Public contact

Name of contact person

1st name Yoshiro
Middle name
Last name Suzuki

Organization

Medical Corporation Himawari association

Division name

Hiyoko Clinic

Zip code

223-0062

Address

1-20-16 Hiyoshihoncho kohoku-ward. Yokohama Japan

TEL

045-563-4115

Homepage URL


Email

ys.himawarikai@gmail.com


Sponsor or person

Institute

Medical Corporation Himawari association

Institute

Department

Personal name



Funding Source

Organization

Medical Corporation Himawari association

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Kanagawa Medical Association

Address

3-1 Fujimicho, Naka-ku, Yokohama 3rd floor, Kanagawa General Medical Hall

Tel

045-241-7000

Email

h-yoda@kanagawa.med.or.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

2020 Year 03 Month 12 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


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

Open public recruiting

Date of protocol fixation

2019 Year 08 Month 29 Day

Date of IRB

2019 Year 08 Month 29 Day

Anticipated trial start date

2019 Year 10 Month 01 Day

Last follow-up date

2021 Year 09 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

nothing paticular


Management information

Registered date

2020 Year 03 Month 11 Day

Last modified on

2020 Year 03 Month 11 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043405


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name