UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059655 |
|---|---|
| Receipt number | R000068238 |
| Scientific Title | Development and Evaluation of a Patient-Participatory, Nudge-Based Simplified Polypharmacy Intervention: Development and Assessment of a Patient Leaflet |
| Date of disclosure of the study information | 2025/11/05 |
| Last modified on | 2025/11/05 23:18:40 |
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Basic information
Public title
Development and Evaluation of a Leaflet to Support Patients in Reviewing Their Medications Together with Healthcare Providers
Acronym
"Medication Review" Leaflet Study
Scientific Title
Development and Evaluation of a Patient-Participatory, Nudge-Based Simplified Polypharmacy Intervention: Development and Assessment of a Patient Leaflet
Scientific Title:Acronym
MPEG Plus Leaflet Study
Region
| Japan |
Condition
Condition
Patients with polypharmacy
Classification by specialty
| Medicine in general | Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to establish the foundation of the MPEG Plus program, which supports autonomous decision-making by patients with polypharmacy and promotes medication review. To achieve this, a patient leaflet based on nudge theory will be developed to encourage patients to consult healthcare providers about their medications, and its acceptability and usefulness will be evaluated through an online randomized controlled trial involving both patients and healthcare professionals.
Basic objectives2
Others
Basic objectives -Others
Evaluation of the Acceptability and Perceived Usefulness of a Patient Leaflet
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Online RCT for Patients: Change in the 11-point scale score for motivation to consult a physician about reviewing my medications before and after viewing the leaflet.
Online RCT for Healthcare Professionals: 11-point scale score for the item Would you consider displaying this leaflet in your medical facility?
Key secondary outcomes
Online RCT for Patients: Six 5-point scale items assessing visibility and acceptability of the leaflet;
Japanese version of PPoD-SF Subscale 1 (Willingness to Review Medications); viewing time; and open-ended comments.
Online RCT for Healthcare Professionals: Six 5-point scale items assessing impressions and acceptability of the leaflet; viewing time; and open-ended comments.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Viewing of a Medication Review leaflet designed based on nudge theory
Interventions/Control_2
Viewing of a general leaflet designed based on the Health Belief Model
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
[Online RCT for Patients]
Adults (aged 18 years or older) who are registered monitors of Macromill Inc. and are prescribed five or more regular medications by a healthcare institution, and who have provided voluntary informed consent to participate in this study after receiving sufficient explanation about its purpose and content.
[Online RCT for Healthcare Professionals]
Licensed physicians or pharmacists who have provided voluntary informed consent to participate in this study after receiving sufficient explanation about its purpose and content.
Key exclusion criteria
Individuals deemed inappropriate for inclusion by the principal investigator
Target sample size
400
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
216-8511
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki-shi, Kanagawa, Japan
TEL
044-977-8111
kenya.ie@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | Kenya |
| Middle name | |
| Last name | Ie |
Organization
St. Marianna University School of Medicine
Division name
Department of General Internal Medicine
Zip code
216-8511
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki-shi, Kanagawa, Japan
TEL
044-977-8111
Homepage URL
kenya.ie@marianna-u.ac.jp
Sponsor or person
Institute
St. Marianna University School of Medicine
Institute
Department
Personal name
Kenya Ie
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology (MEXT), Japan
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Aomori University of Health and Welfare, Faculty of Health Sciences, Showa University, Center for Research Administration
Name of secondary funder(s)
Japan Pharmaceutical Manufacturers Association (JPMA)
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
| 2025 | Year | 11 | Month | 05 | 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 | 31 | Day |
Date of IRB
| 2025 | Year | 10 | Month | 31 | Day |
Anticipated trial start date
| 2025 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 02 | Month | 28 | 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 | 11 | Month | 05 | Day |
Last modified on
| 2025 | Year | 11 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068238
