UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036247 |
|---|---|
| Receipt number | R000041283 |
| Scientific Title | Utility Evaluation of A Drug Administration Guidance Skills Using the Sickday Manual |
| Date of disclosure of the study information | 2019/03/18 |
| Last modified on | 2020/09/28 09:12:38 |
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Basic information
Public title
Utility Evaluation of A Drug Administration Guidance Skills Using the Sickday Manual
Acronym
Utility Evaluation of A Drug Administration Guidance Skills Using the Sickday Manual
Scientific Title
Utility Evaluation of A Drug Administration Guidance Skills Using the Sickday Manual
Scientific Title:Acronym
Utility Evaluation of A Drug Administration Guidance Skills Using the Sickday Manual
Region
| Japan |
Condition
Condition
Diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to evaluate Utility Evaluation of A Drug Administration Guidance Skills Using the Sickday Manual
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in points of comprehension check sheet before and after 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
Self control
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
A Drug Administration Guidance Skills Using the Sickday Manual
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
Patients with diabetes education hospitalization in Endocrinology and Metabolism
Key exclusion criteria
1)Patients who can not obtain consent
2)Patients who are judged inappropriate for participation in research by the attending physician for other reasons
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Osamu |
| Middle name | |
| Last name | Imakyure |
Organization
Fukuoka University
Division name
Faculty of Pharmaceutical Sciences
Zip code
814-0180
Address
8-19-1, Nanakuma, Jonan-ku, Fukuoka-shi, Fukuoka
TEL
092-871-6631
imakyure@fukuoka-u.ac.jp
Public contact
Name of contact person
| 1st name | Osamu |
| Middle name | |
| Last name | Imakyure |
Organization
Fukuoka University
Division name
Faculty of Pharmaceutical Sciences
Zip code
814-0180
Address
8-19-1, Nanakuma, Jonan-ku, Fukuoka-shi, Fukuoka
TEL
092-871-6631
Homepage URL
imakyure@fukuoka-u.ac.jp
Sponsor or person
Institute
Fukuoka University
Institute
Department
Personal name
Funding Source
Organization
Fukuoka University
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
Fukuoka University Chikushi Hospital Clinical Research Support Center
Address
1-1-1, zokumyoin, Chikushino-shi, Fukuoka
Tel
092-921-1011
chikushirinsyo@adm.fukuoka-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
福岡大学筑紫病院（福岡県）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 03 | Month | 18 | 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
Main results already published
Date of protocol fixation
| 2019 | Year | 03 | Month | 13 | Day |
Date of IRB
| 2019 | Year | 03 | Month | 13 | Day |
Anticipated trial start date
| 2019 | Year | 03 | Month | 13 | Day |
Last follow-up date
| 2020 | Year | 02 | Month | 05 | Day |
Date of closure to data entry
| 2020 | Year | 03 | Month | 05 | Day |
Date trial data considered complete
| 2020 | Year | 03 | Month | 05 | Day |
Date analysis concluded
| 2020 | Year | 08 | Month | 05 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 03 | Month | 18 | Day |
Last modified on
| 2020 | Year | 09 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041283
