UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029898 |
|---|---|
| Receipt number | R000034034 |
| Scientific Title | Feasibility study for clinical research data input support using information retrieval from SS-MIX2. |
| Date of disclosure of the study information | 2017/11/09 |
| Last modified on | 2018/11/12 09:30:00 |
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Basic information
Public title
Feasibility study for clinical research data input support using information retrieval from SS-MIX2.
Acronym
Feasibility study for clinical research data input support using information retrieval from SS-MIX2.
Scientific Title
Feasibility study for clinical research data input support using information retrieval from SS-MIX2.
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Hideto Yokoi |
Organization
Kagawa University Hospital
Division name
Division of Medical Informatics
Zip code
Address
Ikenobe 1750-1, Kita-gun, Miki-cho, Kagawa, Japan
TEL
087-891-2135
yokoi@med.kagawa-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naoki Nishimoto |
Organization
Kagawa University Hospital
Division name
Clinical Research Support Center
Zip code
Address
Ikenobe 1750-1, Kita-gun, Miki-cho, Kagawa, Japan
TEL
087-891-2135
Homepage URL
nnishimoto@med.kagawa-u.ac.jp
Sponsor or person
Institute
Kagawa University Hospital
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
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
| 2017 | Year | 07 | Month | 05 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034034
