UMIN-CTR Clinical Trial

Basic information
Public title	Action Research to promote the growth of Disaster countermeasure team in Disaster based hospital.
Acronym	Action Research to promote the growth of Disaster countermeasure team in Disaster based hospital.
Scientific Title	Action Research to promote the growth of Disaster countermeasure team in Disaster based hospital.
Scientific Title:Acronym	Action Research to promote the growth of Disaster countermeasure team in Disaster based hospital.
Region	Japan

Condition
Condition	non
Classification by specialty	Cardiology Nursing Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study to clarify the change of team by team building to the disaster countermeasure team, and to clear effective approach for disaster countersue team to promote team building.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Others
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	This study collect date by quantitative and qualitative. As a quantitative data use two measures. First CICS29 which is to measure cooperative skills for professional, second is Numerical Rating scale to evaluate DCT members motivation for disaster countermeasure activities. As a qualitative data use participant observation and semi structural interview
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	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	1
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Behavior,custom
Interventions/Control_1	Researcher cooperate with Disaster countermeasure team (hereinafter called DCT) are aim to solve problems occur in disaster countermeasure activities use existing theory. Moreover, obtain scientific findings on the problems and aim for inductively to create new knowledge about change process of DCT and effective approach for disaster countermeasure activities. Accordingly, this study use enhancement approach of action research.
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Member of Disaster countermeasure committee
Key exclusion criteria	Those who have the possibility of harming health by research participation
Target sample size	25

Research contact person
Name of lead principal investigator	1st name Yoshiko Middle name Last name Sasaki
Organization	Tokyo medical and dental university
Division name	cooperative doctoral course in disaster nursing
Zip code	101-0062
Address	2-3-10 Kanda-surugadai Chiyoda-ku Tokyo
TEL	03-5280-8070
Email	y-sasaki.dn@tmd.ac.jp

Public contact
Name of contact person	1st name Shigeru Middle name Last name Miyamae
Organization	Tokyo medical and dental university
Division name	cooperative doctoral course in disaster nursing
Zip code	101-0062
Address	2-3-10 Kanda-surugadai Chiyoda-ku Tokyo
TEL	03-5280-8072
Homepage URL
Email	dn150002@tmd.ac.jp

Sponsor
Institute	Tokyo medical and dental university
Institute
Department

Funding Source
Organization	Tokyo medical and dental university
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	Medical Research Ethics Committee of Tokyo Medical and Dental University.
Address	1-5-45 Yushima, Bunkyou-ku, Tokyo
Tel	03-3813-6111
Email	syomu1.adm@tmd.ac.jp

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	自警会 東京警察病院（東京都）

Other administrative information
Date of disclosure of the study information	2018 Year 05 Month 25 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	23
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 05 Month 11 Day
Date of IRB	2018 Year 06 Month 08 Day
Anticipated trial start date	2018 Year 06 Month 06 Day
Last follow-up date	2019 Year 06 Month 05 Day
Date of closure to data entry	2019 Year 06 Month 15 Day
Date trial data considered complete
Date analysis concluded	2019 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date	2018 Year 05 Month 25 Day
Last modified on	2019 Year 12 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000037314