UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000038987
Receipt number R000044459
Scientific Title Relevant factors about informal familial caregiver burden and using public visiting care system
Date of disclosure of the study information 2019/12/25
Last modified on 2019/12/25 11:41:41

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

A basic Survey about using public visiting care system of home-based individuals with severe impairments

Acronym

A basic Survey about using public visiting care system of home-based individuals with severe impairments

Scientific Title

Relevant factors about informal familial caregiver burden and using public visiting care system

Scientific Title:Acronym

Relevant factors about informal familial caregiver burden and using public visiting care system

Region

Japan


Condition

Condition

Individuals with severe impairments

Classification by specialty

Nursing

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate relation with primary familial caregiver burden and caregiver's characteristics and their caregiving conditions

Basic objectives2

Others

Basic objectives -Others

Caregiver burden

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase



Assessment

Primary outcomes

Caregiver burden/Japanese version of the Zarit caregiver burden interview

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Inclusion criteria for visiting care offices:(a)certified by the government (b)providing care for more than one patient with severe impairment (c)providing contact information online. Criteria for patients and caregivers:(a)caregiving for at least one year (b)having applied to be the patients' full-time carer (c)the primary family caregivers for the patient (d)caregiver willing along with the patient to participate in the study

Key exclusion criteria

others than above

Target sample size

300


Research contact person

Name of lead principal investigator

1st name Miku
Middle name
Last name Yamaguchi

Organization

Kyoto Prefectural University of Medicne

Division name

Department of Nursing

Zip code

602-0857

Address

410, Nakagoryo-cho, Kamigyo-ku, Kyoto City, Kyoto 602-0857. Japan.

TEL

075-212-5447

Email

m-yamagu@koto.kpu-m.ac.jp


Public contact

Name of contact person

1st name Miku
Middle name
Last name Yamaguchi

Organization

Kyoto Prefectural University of Medicne

Division name

Department of Nursing

Zip code

602-0857

Address

410, Nakagoryo-cho, Kamigyo-ku, Kyoto City, Kyoto 602-0857. Japan

TEL

075-212-5447

Homepage URL


Email

m-yamagu@koto.kpu-m.ac.jp


Sponsor or person

Institute

Kyoto Prefectural University of Medicine

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

Kyoto Prefectural University of Medicne

Address

410, Nakagoryo-cho, Kamigyo-ku, Kyoto City, Kyoto 602-0857. Japan

Tel

075-212-5447

Email

m-yamagu@koto.kpu-m.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

2019 Year 12 Month 25 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

Enrolling by invitation

Date of protocol fixation

2018 Year 09 Month 20 Day

Date of IRB

2018 Year 04 Month 17 Day

Anticipated trial start date

2019 Year 04 Month 01 Day

Last follow-up date

2020 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

none


Management information

Registered date

2019 Year 12 Month 25 Day

Last modified on

2019 Year 12 Month 25 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044459


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name