UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054463 |
|---|---|
| Receipt number | R000062210 |
| Scientific Title | Development of a new medication compliance check system originated from the SDGs |
| Date of disclosure of the study information | 2024/06/01 |
| Last modified on | 2025/05/26 15:20:19 |
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Basic information
Public title
Development of a new medication compliance check system originated from the SDGs
Acronym
Development of a new medication compliance check system originated from the SDGs
Scientific Title
Development of a new medication compliance check system originated from the SDGs
Scientific Title:Acronym
Development of a new medication compliance check system originated from the SDGs
Region
| Japan |
Condition
Condition
all
Classification by specialty
| Medicine in general | Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Survey of patients behavior related to used PTP sheets recycling activities
Basic objectives2
Others
Basic objectives -Others
Development of a new medication compliance check system
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
percentage of participants who agree with bringing used PTP sheets to the pharmacy
Key secondary outcomes
percentage of participants who continue to bring used PTP sheets for 6 months, medication compliance checking rate
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients
1. Patients who bring prescriptions to the pharmacy and receive the medications continuously
2. Patients who bring prescriptions indicated on the medications for more than 14 days and are treated continuously
Pharmacists
1.Pharmacists who give the medications to the patients and agree to take the questionnaire survey
Key exclusion criteria
Patients
1. Patients who are unable to confirm their own will
2. Patients not prescribed medications packaged in PTP sheets
3. Patients whose medications are packaged one dose
4. Patients who are unable to come to the pharmacy continuously for 6 months
Pharmacists
No criteria
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | Eisei |
| Middle name | |
| Last name | Hori |
Organization
Nagoya City University Graduate School of Pharmaceutical Sciences
Division name
Department of Clinical Pharmacy
Zip code
467-8603
Address
3-1 Tanabe-dori, Mizuho-ku, Nagoya
TEL
+81-052-836-3460
ehori@phar.nagoya-cu.ac.jp
Public contact
Name of contact person
| 1st name | Eisei |
| Middle name | |
| Last name | Hori |
Organization
Nagoya City University Graduate School of Pharmaceutical Sciences
Division name
Department of Clinical Pharmacy
Zip code
467-8603
Address
3-1 Tanabe-dori, Mizuho-ku, Nagoya
TEL
+81-052-836-3460
Homepage URL
ehori@phar.nagoya-cu.ac.jp
Sponsor or person
Institute
Nagoya City University
Institute
Department
Personal name
Funding Source
Organization
UACJ Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Drug Sugi, Asai Pharmacy, Kyowa Pharmacy, UACJ Corporation
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagoya City University Institutional Review Board
Address
1, Kawasumi Mizuho-cho, Mizuho-ku, Nagoya
Tel
+81-052-836-3460
clinical_research@med.nagoya-cu.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
| 2024 | Year | 06 | 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
129
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
| 2024 | Year | 04 | Month | 02 | Day |
Date of IRB
| 2024 | Year | 08 | Month | 02 | Day |
Anticipated trial start date
| 2024 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We will survey on regarding bringing used PTP sheets and medication adherence for patients when starting of this study, 3 months later, and at the end of this study, respectively. We will also survey on usefulness of the medication compliance checking system for pharmacists at the end of this study.
Management information
Registered date
| 2024 | Year | 05 | Month | 23 | Day |
Last modified on
| 2025 | Year | 05 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062210
