UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Pilot study on the possibility of using familysupport tools for psychiatric visiting nursing
Title of the study (Brief title)	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	Sayaka Satoh
Organization	National Institute of Mental Health, NCNP
Division name	Department of Community Mental Health & Law
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	Naonori Yasuma
Organization	National Institute of Mental Health, NCNP
Division name	Department of Community Mental Health & Law
Address	4-1-1 Ogawa-higashi Kodaira Tokyo Japan 187-8553
TEL	042-346-2039
Homepage URL
Email	nnyy712@gmail.com

Sponsor
Institute	National Institute of Mental Health, NCNP
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 09 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038206