UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059656 |
|---|---|
| Receipt number | R000068241 |
| Scientific Title | Development and Evaluation of a Patient-Participatory Polypharmacy Intervention Based on Nudge Theory: Development and Evaluation of a Decision Aid |
| Date of disclosure of the study information | 2025/11/05 |
| Last modified on | 2025/11/05 23:57:08 |
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Basic information
Public title
Development and Evaluation of a Patient-Participatory Polypharmacy Intervention Based on Nudge Theory: Development and Assessment of a Decision Aid
Acronym
Decision Aid Study (MPEG Plus Phase 2)
Scientific Title
Development and Evaluation of a Patient-Participatory Polypharmacy Intervention Based on Nudge Theory: Development and Evaluation of a Decision Aid
Scientific Title:Acronym
MPEG Plus Phase 2
Region
| Japan |
Condition
Condition
Patients with polypharmacy
Classification by specialty
| Medicine in general | Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
As part of the MPEG Plus program, a patient-participatory, nudge-based simplified polypharmacy intervention, this study aims to develop a decision aid that supports patients in discussing medication review with healthcare professionals and to evaluate its acceptability and usefulness.
Basic objectives2
Others
Basic objectives -Others
Evaluation of the Acceptability and Usefulness of a Patient Decision Aid
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Five-point scale scores for the acceptability and usefulness of the decision aid (D-Aid) measured by a self-administered questionnaire after viewing the material
Key secondary outcomes
Associations with demographic variables (age, sex, and educational background or profession) and qualitative content analysis of open-ended comments
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
Participants who have provided informed consent and voluntarily agreed to participate in the study will be included.
1.Patient: Adult inpatients (aged 18 years or older) at Kawasaki Municipal Tama Hospital who are taking five or more regularly prescribed medications.
2.Healthcare provider: Physicians and pharmacists working at Kawasaki Municipal Tama Hospital or St. Marianna University School of Medicine Hospital.
Key exclusion criteria
Individuals who meet one or both of the following criteria will be excluded:
Those for whom it is difficult to confirm understanding of the study or willingness to participate.
Those whose ability to provide consent is impaired due to acute illness or similar conditions.
Target sample size
60
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
Other related organizations
Co-sponsor
Graduate School of Nursing, St. Lukes International University
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 | 11 | Month | 05 | Day |
Date of IRB
| 2025 | Year | 11 | Month | 05 | Day |
Anticipated trial start date
| 2025 | Year | 11 | Month | 10 | 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
This study is a descriptive cross-sectional study conducted as part of the MPEG Plus program, a nudge-based, patient-participatory polypharmacy intervention. The study aims to evaluate the acceptability and usefulness of a developed decision aid (D-Aid). Participants include adult inpatients (taking five or more regularly prescribed medications) at Kawasaki Municipal Tama Hospital, and physicians or pharmacists working at Kawasaki Municipal Tama Hospital or St. Marianna University School of Medicine Hospital. After viewing the D-Aid, participants complete a self-administered questionnaire consisting of five-point scale items on acceptability and usefulness, as well as open-ended comments.
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=R000068241
