UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058548 |
|---|---|
| Receipt number | R000066949 |
| Scientific Title | Development and Empirical Evaluation of a Self-medication Support Scheme Utilizing Healthcare Digital Transformation (DX) Technologies |
| Date of disclosure of the study information | 2025/11/01 |
| Last modified on | 2025/07/31 18:56:44 |
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Basic information
Public title
Development and Evaluation of a Self-medication Support Scheme Using Healthcare DX
Acronym
Smart Self-Care Study
Scientific Title
Development and Empirical Evaluation of a Self-medication Support Scheme Utilizing Healthcare Digital Transformation (DX) Technologies
Scientific Title:Acronym
DX-SMART Study (Digital Transformation-based Self-Medication Assistance:Research and Testing)
Region
| Japan |
Condition
Condition
Cold-like symptoms
Classification by specialty
| Pneumology | Chest surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to develop and empirically evaluate a self-medication support scheme utilizing healthcare digital transformation (DX) technologies, targeting individuals with cold-like symptoms. Specifically, the study involves designing and implementing a digital tool that assists individuals in appropriately assessing their symptoms and using over-the-counter (OTC) medications, while also incorporating a follow-up mechanism to monitor post-medication symptom changes and guide further self-care. The effectiveness of the scheme will be evaluated based on changes in health behavior, self-medication capability, user satisfaction, and appropriate healthcare utilization.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Percentage of visitors who entered information (process indicator).
Follow-up collection rate
Key secondary outcomes
Symptom improvement rate
Adequacy of medical consultation recommendations
Self-reported rate of side effects
Satisfaction and other indicators
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Device,equipment | Behavior,custom |
Interventions/Control_1
Pharmacists provide face-to-face symptom assessment and self-medication advice to visitors presenting with cold-like symptoms.
Subsequently, visitors voluntarily report their post-medication condition and self-care status using a digital tool.
This approach promotes appropriate OTC medication use, continuous monitoring of health status, and supports timely medical consultation, aiming to improve self-care abilities.
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
Individuals who visited a pharmacy or similar facility to purchase OTC medicines for cold-like symptoms.
Individuals aged 18 years or older at the time of registration.
Written informed consent has been obtained from the participant.
Key exclusion criteria
Individuals under the age of 18
Those purchasing OTC medicines on behalf of someone else
Individuals who do not provide written informed consent for participation in the study
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Mitsuko |
| Middle name | |
| Last name | Onda |
Organization
Osaka Medical and Pharmaceutical University
Division name
Faculty of Pharmacy
Zip code
569 1094
Address
4-20-1, Nasahara, Takatsuki, Osaka
TEL
+81-72-690-1059
mitsuko.onda@ompu.ac.jp
Public contact
Name of contact person
| 1st name | Mitsuko |
| Middle name | |
| Last name | Onda |
Organization
Osaka Medical and Pharmaceutical University
Division name
Faculty of Pharmacy
Zip code
569 1094
Address
4-20-1 Nasahara Takatsuki Osaka
TEL
+81-72-690-1059
Homepage URL
mitsuko.onda@ompu.ac.jp
Sponsor or person
Institute
Osaka Medical and Pharmaceutical University
Institute
Department
Personal name
Funding Source
Organization
MEXT(Japan)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics review Committee of Osaka Medical and Pharmaceutical University
Address
2 7 Daigakumachi, Takatsuki shi, Osaka 569- 0801, Japan
Tel
072 683 1221
rinri@ompu.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 | 01 | 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
Anticipated trial start date
| 2025 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 04 | Month | 30 | 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 | 07 | Month | 22 | Day |
Last modified on
| 2025 | Year | 07 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066949
