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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000036181
Receipt No. R000041216
Scientific Title Study of the pharmacist is manageable Gram stain method
Date of disclosure of the study information 2019/03/12
Last modified on 2019/03/13

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Basic information
Public title Study of the pharmacist is manageable Gram stain method
Acronym Study of the pharmacist is manageable Gram stain method
Scientific Title Study of the pharmacist is manageable Gram stain method
Scientific Title:Acronym Study of the pharmacist is manageable Gram stain method
Region
Japan

Condition
Condition Infection disease
Classification by specialty
Infectious disease
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We will consider the method of Gram stain that is easy to handle for pharmacists to test for smear of bacteria.
Basic objectives2 Others
Basic objectives -Others Staining status and ease of operation of each Gram stain kit.
Comparison of staining status in company's manual group and original manual and movie group.
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Staining status (visibility, distinguishability) of each Gram stain kit
Key secondary outcomes Ease of operation of each Gram stain kit.

Base
Study type Interventional

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

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Maneuver
Interventions/Control_1 Gram stain procedures written by the reagent company
Interventions/Control_2 Custom-made Gram stain procedures and videos
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
21 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Pharmacists or students 4th grade or above at faculty of pharmacy Takasaki University of Health and Welfare.
Key exclusion criteria None
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Akiko
Middle name
Last name Omi
Organization Faculty of Pharmacy Takasaki University of Health and Welfare
Division name Laboratory of Community Healthcare
Zip code 370-0033
Address 60 Nakaorui-machi,Takasaki-shi,Gunma
TEL 027-352-1180
Email omi@takasaki-u.ac.jp

Public contact
Name of contact person
1st name Akiko
Middle name
Last name Omi
Organization Faculty of Pharmacy Takasaki University of Health and Welfare
Division name Laboratory of Community Healthcare
Zip code 370-0033
Address 60 Nakaorui-machi,Takasaki-shi,Gunma
TEL 027-352-1180
Homepage URL
Email omi@takasaki-u.ac.jp

Sponsor
Institute Laboratory of Community Healthcare Faculty of Pharmacy Takasaki University of Health and Welfare
Institute
Department

Funding Source
Organization Takasaki University of Health and Welfare
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 Takasaki University of Health and Welfare
Address 37-1 Nakaorui-machi,Takasaki-shi,Gunma
Tel 027-352-1290
Email mune@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 03 Month 12 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 Open public recruiting
Date of protocol fixation
2019 Year 02 Month 26 Day
Date of IRB
2019 Year 02 Month 26 Day
Anticipated trial start date
2019 Year 03 Month 13 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 03 Month 12 Day
Last modified on
2019 Year 03 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041216

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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