UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of psychoeducational appoach on the prevention of water intoxication for inpatients with reccurent polysipsia
Title of the study (Brief title)	Psychoeducational approach for inpatients with reccurent polydipsia
Region	Japan

Condition
Condition	Schizophrenia
Classification by specialty	Psychiatry Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To improve the behavioral disorder
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Normalized diurnal weight gain
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	Psychoeducation Behavioral therapy
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	47 years-old <=
Age-upper limit	50 years-old >=
Gender	Female
Key inclusion criteria	Inpatients at high risk for water intoxication due to reccurent polydipsia
Key exclusion criteria	none
Target sample size	3

Research contact person
Name of lead principal investigator	Katsumi Matsumoto,BSN
Organization	Sawa Hospital
Division name	Nursing Division
Address	1-9-1 Shiroyama, Toyonaka City, Osaka, Japan, 561-0803
TEL	06-6865-1211
Email	nur@hokuto-kai.com

Public contact
Name of contact person	Katsumi Matsumoto,BSN
Organization	Sawa Hospital
Division name	Nursing Division
Address	1-9-1 Shiroyama, Toyonaka City, Osaka, Japan, 561-0803
TEL	06-6865-1211
Homepage URL
Email	nur@hokuto-kai.com

Sponsor
Institute	Sawa Hospital Nursing Division
Institute
Department

Funding Source
Organization	Sawa Hospital Nursing Division
Organization
Division
Category of Funding Organization	Other
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 06 Month 14 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 06 Month 14 Day
Anticipated trial start date	2018 Year 06 Month 14 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2018 Year 04 Month 07 Day
Last modified on	2019 Year 03 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036036