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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000032142
Receipt No. R000036036
Official scientific title of the study Effect of psychoeducational appoach on the prevention of water intoxication for inpatients with reccurent polysipsia
Date of disclosure of the study information 2018/06/14
Last modified on 2018/03/21

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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 Preinitiation
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
2018 Year 03 Month 21 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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