UMIN-CTR Clinical Trial

Basic information
Public title	The effect of introduction of crisis plan on the improvement of self-efficacy and alleviation of anxiety in patients at psychiatric emergency ward.
Acronym	The effect of introduction of crisis plan on the improvement of self-efficacy and alleviation of anxiety in patients at psychiatric emergency ward.
Scientific Title	The effect of introduction of crisis plan on the improvement of self-efficacy and alleviation of anxiety in patients at psychiatric emergency ward.
Scientific Title:Acronym	The effect of introduction of crisis plan on the improvement of self-efficacy and alleviation of anxiety in patients at psychiatric emergency ward.
Region	Japan

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

Objectives
Narrative objectives1	To study the effect of introduction of crisis plan on the improvement of self-efficacy and alleviation of anxiety in patients at psychiatric emergency ward.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Self-Efficacy for Community Life scale
Key secondary outcomes	State-Trait Anxiety Inventory-Form Y:STAI-Y

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	Educational,Counseling,Training
Type of intervention	Behavior,custom
Interventions/Control_1	Introduction of crisis plan
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	Not applicable
Gender	Male
Key inclusion criteria	The Patient with Schizophrenia in psychiatric emergency ward
Key exclusion criteria	Patients under 20 years old. Patients whom physicians in charge do not allow them to participate.
Target sample size	12

Research contact person
Name of lead principal investigator	1st name Tomoko Middle name Last name Ooka
Organization	Sawa Hospital
Division name	Nursing Division
Zip code	561-0803
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	1st name Tomoko Middle name Last name Ooka
Organization	Sawa Hospital
Division name	Nursing Division
Zip code	561-0803
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)

IRB Contact (For public release)
Organization	Research ethics committee,Social medical corporation Hokutokai
Address	1-9-1 Shiroyama,Toyonaka City,Osaka,Japan,561-0803
Tel	06-6865-1211
Email	clin-res@hokuto-kai.com

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 08 Month 27 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	2019 Year 08 Month 20 Day
Date of IRB	2019 Year 08 Month 20 Day
Anticipated trial start date	2019 Year 08 Month 27 Day
Last follow-up date	2019 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 08 Month 27 Day
Last modified on	2020 Year 03 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043118