UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043161 |
|---|---|
| Receipt number | R000048124 |
| Scientific Title | Effect of diabetes educational program for prevent the hypoglycemia in pharmacies: A cluster Randomized Controlled Trial |
| Date of disclosure of the study information | 2021/02/01 |
| Last modified on | 2023/09/27 10:44:40 |
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Basic information
Public title
Effect of diabetes educational program for prevent the hypoglycemia in pharmacies: A cluster Randomized Controlled Trial
Acronym
Effect of diabetes educational program for prevent the hypoglycemia in pharmacies: A cluster Randomized Controlled Trial
Scientific Title
Effect of diabetes educational program for prevent the hypoglycemia in pharmacies: A cluster Randomized Controlled Trial
Scientific Title:Acronym
Effect of diabetes educational program for prevent the hypoglycemia in pharmacies: A cluster Randomized Controlled Trial
Region
| Japan |
Condition
Condition
diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To test whether pharmacists' use of the Sick Day card (developed by the researchers) in teaching diabetic patients will improve patients' understanding of sick day and what to do when sick day occurs.
Basic objectives2
Others
Basic objectives -Others
Examine the impact of the Sick Day Card initiative on pharmacists.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Differences between the two groups of changes in patient anxiety, motivation, and attitude scores measured by a questionnaire survey
Key secondary outcomes
Comparison of the number of hypoglycemias.
Confirmation of Appropriate response during sick day.
Existence of doctor's instructions.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Use sick day card for medicine notebook
Interventions/Control_2
Not use sick day card for medicine notebook
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1)Patients who are 20 years old or more at the time of consent acquisition.
(2) Patients provided informed consent
(3)Patients who have been issued prescriptions by medical institutions
Key exclusion criteria
(1)Requested for cancellation from patients
(2)Interrupted due to the circumstances of the research patients (moving, changing doctor / hospital, busy, unfollowable)
(3)Judged that evaluation is not possible due to serious deviation from protocol
(4)Patients judged inappropriate in this study
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | keisuke |
| Middle name | |
| Last name | kado |
Organization
KRAFT HONSHA Inc.
Division name
kyoikukikakubu
Zip code
100-8225
Address
PALACE building-10F,1-1-1,Marunouchi,Tiyoda-ku,Tokyo,Japan
TEL
03-5208-9800
k-kado@kraft-net.co.jp
Public contact
Name of contact person
| 1st name | keisuke |
| Middle name | |
| Last name | kado |
Organization
KRAFT HONSHA Inc.
Division name
kyoikukikakubu
Zip code
100-8225
Address
PALACE building-10F,1-1-1,Marunouchi,Tiyoda-ku,Tokyo,Japan
TEL
03-5208-9800
Homepage URL
k-kado@kraft-net.co.jp
Sponsor or person
Institute
KRAFT HONSHA Inc.
Institute
Department
Personal name
Funding Source
Organization
KRAFT HONSHA Inc.
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Health Informatics, Kyoto University School of Public Health
KRAFT Inc.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
KRAFT Inc. Institutional Review Board
Address
PALACE building-10F,1-1-1,Marunouchi,Tiyoda-ku,Tokyo,Japan
Tel
03-5208-9800
rinriiinkai@kraft-net.co.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
| 2021 | Year | 02 | Month | 01 | 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
318
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
| 2021 | Year | 01 | Month | 21 | Day |
Date of IRB
| 2021 | Year | 01 | Month | 21 | Day |
Anticipated trial start date
| 2021 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 01 | Month | 28 | Day |
Last modified on
| 2023 | Year | 09 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048124
