UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061685 |
|---|---|
| Receipt number | R000070335 |
| Scientific Title | Development and Evaluation of a Nudge-Based Patient-Participatory Polypharmacy Intervention: Construction and Assessment of the MPEG Plus Clinical Decision Support System |
| Date of disclosure of the study information | 2026/05/25 |
| Last modified on | 2026/05/25 23:55:47 |
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Basic information
Public title
Development and Evaluation of a Patient-Participatory Medication Review Support System
Acronym
Patient-Participatory Medication Review Support Study
Scientific Title
Development and Evaluation of a Nudge-Based Patient-Participatory Polypharmacy Intervention: Construction and Assessment of the MPEG Plus Clinical Decision Support System
Scientific Title:Acronym
MPEG Plus Phase 3
Region
| Japan |
Condition
Condition
Polypharmacy
Classification by specialty
| Medicine in general | Geriatrics | Not applicable |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the usability, understandability, acceptability, and utility of a patient-participatory medication review support system prototype in real-world clinical settings among patients and healthcare professionals.
Basic objectives2
Others
Basic objectives -Others
To evaluate the feasibility, acceptability, and impact on the medication review process of a patient-participatory medication review support system.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Japanese version of the System Usability Scale (SUS) score assessed immediately after use of the MPEG Plus prototype system
Key secondary outcomes
Free-text feedback regarding usability, understandability, and utility assessed immediately after use of the MPEG Plus prototype system.
Five-point self-assessment of reference frequency and perceived usefulness of OPT and D-Aid information assessed immediately after use of the MPEG Plus prototype system.
Changes in medication review decisions and details of modifications assessed during the field evaluation period.
Reference frequency of OPT, D-Aid information, and nudge messages assessed during the field evaluation period.
Time required for medication review decision-making assessed during the field evaluation period.
Qualitative evaluation of feasibility, acceptability, and operational challenges based on focus group interviews conducted after completion of the field evaluation period.
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
[Patients]
Hospitalized patients aged 65 years or older at Kawasaki Municipal Tama Hospital
Patients taking five or more regular oral medications continuously for at least 4 weeks
Patients who provide written informed consent
[Healthcare professionals]
Physicians, pharmacists, or nurses working at Kawasaki Municipal Tama Hospital
Healthcare professionals routinely involved in medication management for older adults
Individuals who provide written informed consent
Key exclusion criteria
[Patients]
Patients with severe cognitive impairment, severe psychiatric illness, acute illness, or other conditions causing serious communication difficulties
Patients judged by the principal investigator to have excessive burden or disadvantage associated with study participation
Patients otherwise judged inappropriate for participation by the principal investigator
[Healthcare professionals]
Individuals considered unable to adequately participate in study evaluation procedures
Individuals otherwise judged inappropriate for participation by the principal investigator
Target sample size
62
Research contact person
Name of lead principal investigator
| 1st name | Kenya |
| Middle name | |
| Last name | Ie |
Organization
St. Marianna University School of Medicine
Division name
Department of General Internal Medicine
Zip code
214-8525
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki-shi, Kanagawa, Japan
TEL
0570-028-111
iekenya0321@gmail.com
Public contact
Name of contact person
| 1st name | Ayano |
| Middle name | |
| Last name | Takagai |
Organization
St. Marianna University School of Medicine
Division name
Department of General Internal Medicine
Zip code
214-8525
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki-shi, Kanagawa, Japan
TEL
0570-028-111
Homepage URL
ayama123.work@gmail.com
Sponsor or person
Institute
St. Marianna University School of Medicine
Institute
Department
Personal name
Kenya Ie
Funding Source
Organization
Japan Society for the Promotion of Science (JSPS) KAKENHI Grant-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
Japan Pharmaceutical Manufacturers Association (JPMA) Research Support Grant 2024
IRB Contact (For public release)
Organization
St. Marianna University School of Medicine
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki-shi, Kanagawa 216-8511, Japan
Tel
044-977-8111
daigakuin-kenkyu-001@marianna-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
| 2026 | Year | 05 | Month | 25 | 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
| 2026 | Year | 04 | Month | 23 | Day |
Date of IRB
| 2026 | Year | 04 | Month | 23 | Day |
Anticipated trial start date
| 2026 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
N/A
Management information
Registered date
| 2026 | Year | 05 | Month | 25 | Day |
Last modified on
| 2026 | Year | 05 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070335
