UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049562 |
|---|---|
| Receipt number | R000056444 |
| Scientific Title | Evaluation of the use of drug therapy leaflets for diabetic sick days |
| Date of disclosure of the study information | 2022/12/20 |
| Last modified on | 2023/11/21 11:47:10 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Evaluation of the use of drug therapy leaflets for diabetic sick days
Acronym
Evaluation of the use of drug therapy leaflets for diabetic sick days
Scientific Title
Evaluation of the use of drug therapy leaflets for diabetic sick days
Scientific Title:Acronym
Evaluation of the use of drug therapy leaflets for diabetic sick days
Region
| Japan |
Condition
Condition
Diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose is to evaluate the effectiveness of guidance using a uniquely created leaflet for drug therapy during diabetes sick days.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary outcome measure was the number and proportion of patients who understood how to deal with antidiabetic drugs during sick days.
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Guidance to patients using a leaflet for pharmacotherapy during diabetic sick days that was originally created
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
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Outpatients undergoing drug therapy for diabetes
Key exclusion criteria
Patients with memory impairment or dementia.
Patients who requested to withdraw consent.
Target sample size
160
Research contact person
Name of lead principal investigator
| 1st name | Satoru |
| Middle name | |
| Last name | Yamada |
Organization
Kitasato Institute Hospital
Division name
Diabetes Center
Zip code
108-8642
Address
Shirokane 5-9-1, Minato-ku, Tokyo, Japan
TEL
03-3444-6161
yamada-s@insti.kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | Gaku |
| Middle name | |
| Last name | Inoue |
Organization
Kitasato Institute Hospital
Division name
Department of Pharmacy
Zip code
108-8642
Address
Shirokane 5-9-1, Minato-ku, Tokyo, Japan
TEL
03-3444-6161
Homepage URL
inoueg@pharm.kitasato-u.ac.jp
Sponsor or person
Institute
Diabetes Center, Kitasato Institute Hospital
Institute
Department
Personal name
Funding Source
Organization
Diabetes Center, Kitasato Institute Hospital
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
Reseach Ethics Committee, Kitasato Institute Hospital
Address
Shirokane 5-9-1, Minato-ku, Tokyo, Japan
Tel
03-5791-6106
kenkyu@insti.kitasato-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
北里大学北里研究所病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 12 | Month | 20 | 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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 12 | Month | 20 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 06 | Day |
Anticipated trial start date
| 2022 | Year | 12 | Month | 20 | Day |
Last follow-up date
| 2024 | 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
| 2022 | Year | 11 | Month | 20 | Day |
Last modified on
| 2023 | Year | 11 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056444
