UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059544 |
|---|---|
| Receipt number | R000067971 |
| Scientific Title | Evaluation of the usefulness of medication reminder devices under long-term care insurance and medical insurance in Japan |
| Date of disclosure of the study information | 2025/10/27 |
| Last modified on | 2025/10/27 10:19:21 |
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Basic information
Public title
Evaluation of the usefulness of medication reminder devices under long-term care insurance and medical insurance in Japan
Acronym
Evaluation of the usefulness of medication reminder devices under long-term care insurance and medical insurance in Japan
Scientific Title
Evaluation of the usefulness of medication reminder devices under long-term care insurance and medical insurance in Japan
Scientific Title:Acronym
Evaluation of the usefulness of medication reminder devices under long-term care insurance and medical insurance in Japan
Region
| Japan |
Condition
Condition
Chronic disease
Classification by specialty
| Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigate the usefulness of using medication reminder devices within the framework of long-term care insurance and medical insurance in Japan.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Self-administration medication rate
Key secondary outcomes
Self-rated level of performanc, Self-rated level of perceived burden, Degree of family concern
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
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
use of medication reminder device
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
65 years of age or older, users of in-home medical care management guidance (long-term care insurance) or home-visit drug management guidance (medical insurance), those who are assisted in taking their medications at least once a week or those who have forgotten to take their medications.
Key exclusion criteria
Severe cognitive impairment. The patient is concerned about refusing medication and is unwilling to take medication. Overnight stay or going out during the time of medication administration is frequent. Lack of ability (vision, hearing, upper limb function, mobility, swallowing function) to take medication in response to the prompts of a medication reminder device. The patient is concerned that he/she may forget to take the medication once taken. Prescription medication is not in a form or quantity that can be stored in the medication reminder device.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Tomoko |
| Middle name | |
| Last name | Kamimura |
Organization
Shinshu University
Division name
School of Health Sciences
Zip code
3908621
Address
3-1-1 Asahi Matsumoto, Japan
TEL
0263-372395
tkamimu@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | Tomoko |
| Middle name | |
| Last name | Kamimura |
Organization
Shinshu University
Division name
School of Health Sciences
Zip code
3900303
Address
3-1-1 Asahi Mastumoto Japan
TEL
0263-372395
Homepage URL
tkamimu@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University
Institute
Department
Personal name
Funding Source
Organization
Shinshu University
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Life Sciences and Medical Research Ethics Committee
Address
3-1-1 Asahi Matsumoto Japan
Tel
0263-373099
mdrinri@shinshu-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
| 2025 | Year | 10 | Month | 27 | 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
Enrolling by invitation
Date of protocol fixation
| 2025 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 10 | Month | 21 | Day |
Anticipated trial start date
| 2025 | Year | 10 | Month | 27 | Day |
Last follow-up date
| 2027 | Year | 04 | Month | 01 | 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 | 27 | Day |
Last modified on
| 2025 | Year | 10 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000067971
