UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047176 |
|---|---|
| Receipt number | R000053812 |
| Scientific Title | Medication guidance using the medication support device data |
| Date of disclosure of the study information | 2022/03/25 |
| Last modified on | 2024/09/10 09:11:52 |
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Basic information
Public title
Effectiveness for pharmacist, patient and family to medication guidance using the medication support device data
Acronym
Medication guidance using the medication support device data
Scientific Title
Medication guidance using the medication support device data
Scientific Title:Acronym
Medication guidance using the medication support device data
Region
| Japan |
Condition
Condition
Diabetes
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Send the medication support device data for diabetic patients to the electronic medication notebook to verify whether it is effective for pharmacists' medication guidance.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluate the presence or absence of how the pharmacist used the medication history data for medication guidance and the content of the intervention over time.
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
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Once a week, pharmacist check the medication history data of via the electronic medication notebook and follow up with the patient by telephone etc. as necessary.
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
Pharmacist who provides medication guidance to diabetics and can introduce an electronic medication notebook to a computer at a pharmacy.
Key exclusion criteria
Diabetic patient is not taking one-dose packaged medicine, cannot introduce electronic medication notebooks at pharmacy.
Target sample size
6
Research contact person
Name of lead principal investigator
| 1st name | Ryoji |
| Middle name | |
| Last name | SUZUKI |
Organization
Takasaki University of Health and Welfare
Division name
Healthcare Informatics
Zip code
3700033
Address
37-1, Nakaorui-Machi, Takasaki, Gunma 370-0033. Japan
TEL
0273521290
suzuki-r@takasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Ryoji |
| Middle name | |
| Last name | SUZUKI |
Organization
Takasaki University of Health and Welfare
Division name
Healthcare Informatics
Zip code
3700033
Address
37-1, Nakaorui-Machi, Takasaki, Gunma 370-0033. Japan
TEL
0273521290
Homepage URL
suzuki-r@takasaki-u.ac.jp
Sponsor or person
Institute
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, Gunma 370-0033. Japan
Tel
0273521290
suzuki-r@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
| 2022 | Year | 03 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
1
Results
The results of one subject's experiment were published.
Results date posted
| 2024 | Year | 09 | Month | 10 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2024 | Year | 02 | Month | 10 | Day |
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
| 2022 | Year | 03 | Month | 10 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 10 | Day |
Anticipated trial start date
| 2022 | Year | 03 | Month | 11 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2024 | Year | 01 | Month | 10 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 03 | Month | 15 | Day |
Last modified on
| 2024 | Year | 09 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053812
