UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059355 |
|---|---|
| Receipt number | R000067806 |
| Scientific Title | An exploratory study on the use of a smart medication box to improve medication adherence |
| Date of disclosure of the study information | 2025/10/15 |
| Last modified on | 2025/10/09 13:30:14 |
* 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
An exploratory study on the use of a smart medication box to improve medication adherence
Acronym
Evaluation of the effect of a smart medication box on improving medication adherence
Scientific Title
An exploratory study on the use of a smart medication box to improve medication adherence
Scientific Title:Acronym
Evaluation of the effect of a smart medication box on improving medication adherence
Region
| Japan |
Condition
Condition
Patients undergoing treatment for chronic diseases.
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To explore the impact of the medication reminder function of a smart medication box on behavioral change among users.
Basic objectives2
Others
Basic objectives -Others
Regarding medication adherence maintenance, we explore the involvement of medication adherence in medication adherence records rather than self-reported evaluations. We also explore the involvement of medication adherence records and pharmacist-provided medication support follow-up.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Achievement rate of medication adherence before and after using the smart medication box.
Key secondary outcomes
Changes in pharmacists' understanding of medication status and medication support follow-up.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Behavior,custom |
Interventions/Control_1
Use the smart medication box for 3 months
Interventions/Control_2
Conventional medication management
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Subjects who are aged 18 or older who understand the purpose of this study and willingly consent to participate.
2) Subjects who can understand questionnaires and instructions in Japanese.
3) Subjects who are receiving home medical care.
Key exclusion criteria
1) Subjects who are under the age of 17.
2) Subjects who cannot understand questionnaires or instructions in Japanese.
3) Subjects who are mpaired cognitive function.
4) Subjects who are limited due to paralysis or other reasons.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Daichi |
| Middle name | |
| Last name | Nagashima |
Organization
Yokohama University of Pharmacy
Division name
Laboratory of Clinical Pharmaceutics
Zip code
245-0066
Address
601 Matano cho, Totsuka ku, Yokohama, Kanagaw a, Kanagawa
TEL
045-859-1300
daichi.nagashima@yok.hamayaku.ac.jp
Public contact
Name of contact person
| 1st name | Daichi |
| Middle name | |
| Last name | Nagashima |
Organization
Yokohama University of Pharmacy
Division name
Laboratory of Clinical Pharmaceutics
Zip code
245-0066
Address
601 Matano cho, Totsuka ku, Yokohama, Kanagaw a, Kanagawa
TEL
045-859-1300
Homepage URL
daichi.nagashima@yok.hamayaku.ac.jp
Sponsor or person
Institute
Yokohama University of Pharmacy
Institute
Department
Personal name
Funding Source
Organization
SMK Co.,Ltd
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
SMK Co.,Ltd
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Human Research Ethics Committee, Yokohama Un iversity of Pharmacy
Address
601 Matano cho, Totsuka ku, Yokohama, Kanagaw a, Kanagawa
Tel
045-859-1300
rinshokenkyu_rinri@yok.hamayaku.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
| 2025 | Year | 10 | Month | 15 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 09 | Month | 30 | Day |
Anticipated trial start date
| 2025 | Year | 10 | Month | 15 | 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
Other
Other related information
Management information
Registered date
| 2025 | Year | 10 | Month | 09 | Day |
Last modified on
| 2025 | Year | 10 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067806
