UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000033509
Receipt number R000038206
Scientific Title Pilot study on the possibility of using familysupport tools for psychiatric visiting nursing
Date of disclosure of the study information 2018/09/01
Last modified on 2019/03/06 11:29:02

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Basic information

Public title

Pilot study on the possibility of using familysupport tools for psychiatric visiting nursing

Acronym

Pilot study on the possibility of using familysupport tools for psychiatric visiting nursing

Scientific Title

Pilot study on the possibility of using familysupport tools for psychiatric visiting nursing

Scientific Title:Acronym

Pilot study on the possibility of using familysupport tools for psychiatric visiting nursing

Region

Japan


Condition

Condition

Schizophrenia

Classification by specialty

Psychiatry

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Improvement of the burden of the family

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Zarit Caregiver Burden Interview, K6

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

Treatment

Type of intervention

Behavior,custom

Interventions/Control_1

Family support tool for schizophrenia

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

20 years-old <=

Age-upper limit

75 years-old >

Gender

Male and Female

Key inclusion criteria

Families of users receiving assistance
Persons whose age is 20 years or older at the time of consent acquisition
The user must be schizophrenia
Living with the user, being the primary caregiver
Persons receiving support from the research
cooperation team
It is a case that the visiting nurses want
to connect to social resources

Key exclusion criteria

Age is under 20 years old
Others who the research director judges inappropriate

Target sample size

15


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Sayaka Satoh

Organization

National Institute of Mental Health, NCNP

Division name

Department of Community Mental Health & Law

Zip code


Address

4-1-1 Ogawa-higashi Kodaira Tokyo Japan 187-8553

TEL

042-346-2039

Email

sayakas@ncnp.go.jp


Public contact

Name of contact person

1st name
Middle name
Last name Naonori Yasuma

Organization

National Institute of Mental Health, NCNP

Division name

Department of Community Mental Health & Law

Zip code


Address

4-1-1 Ogawa-higashi Kodaira Tokyo Japan 187-8553

TEL

042-346-2039

Homepage URL


Email

nnyy712@gmail.com


Sponsor or person

Institute

National Institute of Mental Health, NCNP

Institute

Department

Personal name



Funding Source

Organization

National Institute of Mental Health, NCNP

Organization

Division

Category of Funding Organization

Government offices of other countries

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

2018 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


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

2018 Year 09 Month 01 Day

Date of IRB


Anticipated trial start date

2018 Year 09 Month 01 Day

Last follow-up date

2019 Year 02 Month 28 Day

Date of closure to data entry

2019 Year 02 Month 28 Day

Date trial data considered complete

2019 Year 02 Month 28 Day

Date analysis concluded

2019 Year 02 Month 28 Day


Other

Other related information



Management information

Registered date

2018 Year 07 Month 25 Day

Last modified on

2019 Year 03 Month 06 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038206


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name