UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Feasibility study for clinical research data input support using information retrieval from SS-MIX2.
Title of the study (Brief title)	Feasibility study for clinical research data input support using information retrieval from SS-MIX2.
Region	Japan

Condition
Condition	nonvalvular atrial fibrillation
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	In current clinical trials and registry studies, manual data input is one of the main costs. Cost effectiveness is expected for the software data input support (SDIS), however, it has still remained validated. Research of SDIS effectiveness has a few prior studies because SDIS tends to depend on the IT infrastructure and have poor reproducibility. Therefore, we intended to create a hypothesis that SDIS is more effective than manual input by clinical research coordinator (CRC) to an electronic data capturing (EDC) in this research. This is an exploratory study rather than a confirmative study verifying the effectiveness of software support.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	time interval of data input for a patient
Key secondary outcomes	typing count based on data entry.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Other
Interventions/Control_1	No software data input support
Interventions/Control_2	Software data input support
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	1)no age limitation 2)no gender limitation 3)CRC who input data to the registry database
Key exclusion criteria	1)Person who cannot type a keyboard 2)CRC who have their career within 3 month
Target sample size	2

Research contact person
Name of lead principal investigator	Hideto Yokoi
Organization	Kagawa University Hospital
Division name	Division of Medical Informatics
Address	Ikenobe 1750-1, Kita-gun, Miki-cho, Kagawa, Japan
TEL	087-891-2135
Email	yokoi@med.kagawa-u.ac.jp

Public contact
Name of contact person	Naoki Nishimoto
Organization	Kagawa University Hospital
Division name	Clinical Research Support Center
Address	Ikenobe 1750-1, Kita-gun, Miki-cho, Kagawa, Japan
TEL	087-891-2135
Homepage URL
Email	nnishimoto@med.kagawa-u.ac.jp

Sponsor
Institute	Kagawa University Hospital
Institute
Department

Funding Source
Organization	self-funding
Organization
Division
Category of Funding Organization	Self funding
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	香川大学　医学部附属病院

Other administrative information
Date of disclosure of the study information	2017 Year 11 Month 09 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 07 Month 05 Day
Anticipated trial start date	2017 Year 07 Month 05 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	2017 Year 11 Month 09 Day
Last modified on	2018 Year 11 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000034034