UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036181 |
|---|---|
| Receipt number | 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 | 2021/09/15 10:16:43 |
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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
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
omi@takasaki-u.ac.jp
Sponsor or person
Institute
Laboratory of Community Healthcare Faculty of Pharmacy Takasaki University of Health and Welfare
Institute
Department
Personal name
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
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
Terminated
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
| 2021 | Year | 03 | Month | 31 | Day |
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
| 2021 | Year | 09 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041216
