UMIN-CTR Clinical Trial

Basic information
Public title	Care information sharing ICT system between a hospital and home -Evaluation of care manuals for each patient-
Acronym	Care information sharing ICT system between a hospital and home -Evaluation of care manuals for each patient-
Scientific Title	Care information sharing ICT system between a hospital and home -Evaluation of care manuals for each patient-
Scientific Title:Acronym	Care information sharing ICT system between a hospital and home -Evaluation of care manuals for each patient-
Region	Japan

Condition
Condition	non
Classification by specialty	Nursing
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To develop and evaluate the ICT tool in making care manuals.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Evaluation of care manuals Effectiveness of care manuals Standardization of care Relieving nurse's anxiety The time and work that care manuals making takes The time for evaluation is three months and six months after the intervention.
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	Educational,Counseling,Training
Type of intervention	Other
Interventions/Control_1	Information sharing to use the ICT tool in making care manuals.
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	Nurse
Key exclusion criteria	Out of the nurse
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Eiko Middle name Last name Ogasawara
Organization	Takasaki University of Health and Welfare
Division name	Faculty of Health Care
Zip code	370-0033
Address	501 Nakaorui-machi, Takasaki-shi, Gunma 370-0033, Japan
TEL	027-352-1291
Email	ogasawara@takasaki-u.ac.jp

Public contact
Name of contact person	1st name Eiko Middle name Last name Ogasawara
Organization	Takasaki University of Health and Welfare
Division name	Faculty of Health Care
Zip code	370-0033
Address	501 Nakaorui-machi, Takasaki-shi, Gunma 370-0033, Japan
TEL	027-352-1291
Homepage URL
Email	ogasawara@takasaki-u.ac.jp

Sponsor
Institute	Takasaki University of Health and Welfare
Institute
Department

Funding Source
Organization	Takasaki University of Health and Welfare
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	ERC at Takasaki University of Health and Welfare
Address	501 Nakaorui-machi, Takasaki-shi, Gunma 370-0033, Japan
Tel	027-352-1291
Email	kuwabara@takasaki-u.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

Other administrative information
Date of disclosure of the study information	2019 Year 04 Month 06 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	2018 Year 05 Month 07 Day
Date of IRB	2018 Year 05 Month 07 Day
Anticipated trial start date	2019 Year 04 Month 10 Day
Last follow-up date	2021 Year 03 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 04 Month 04 Day
Last modified on	2021 Year 03 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041482