UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059840 |
|---|---|
| Receipt number | R000068433 |
| Scientific Title | An Exploratory Study on the Impact of Ophthalmology Visit Recommendations by Community Pharmacists for Diabetic Patients. |
| Date of disclosure of the study information | 2025/11/20 |
| Last modified on | 2025/11/20 17:48:50 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
An Exploratory Study on the Impact of Ophthalmology Visit Recommendations by Community Pharmacists for Diabetic Patients.
Acronym
UNISMILE-INSPIRE Study
Scientific Title
An Exploratory Study on the Impact of Ophthalmology Visit Recommendations by Community Pharmacists for Diabetic Patients.
Scientific Title:Acronym
UNISMILE-INSPIRE Study
Region
| Japan |
Condition
Condition
Diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism | Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
An Exploratory Study aiming to investigate the trend of consultation behavior among diabetic patients by explaining the risk of diabetic retinopathy and the necessity of regular ophthalmology consultation by pharmacy pharmacists. The objective is to clarify the feasibility, acceptability, and direction of behavioral change of primary preventive intervention via pharmacy pharmacists.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Ophthalmology visit rate within 4 months from baseline (comparison between intervention and control groups)
Key secondary outcomes
1. Ophthalmology visit within 2 months from the initial contact (interim evaluation)
2. Association between patient background factors (HbA1c level, age, sex) and ophthalmology visit behavior.
3. Comparison of ophthalmology visit rates by background factors within each group.
4. Difference in the impact of background factors between the two groups (interaction)
5. Exploratory assessment of ophthalmology visit behavior patterns by patient background characteristics.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
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
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Pharmacists provide education on diabetic retinopathy and the necessity of ophthalmology visits using an educational booklet based on a predefined protocol. The booklet is distributed to participants after the explanation.
Interventions/Control_2
Pharmacists provide routine medication counseling only.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Visited UNISMILE Pharmacy Nasushiobara during the recruitment period (first 2 months)
2. Diagnosed with type 2 diabetes and prescribed antidiabetic medications (injectable or oral)
3. Receiving prescription-based dispensing
4. Provided informed consent after understanding the study purpose.
Key exclusion criteria
1. Evident cognitive impairment hindering study participation.
2. Visual impairment preventing comprehension of educational materials.
3. Expected relocation or hospital transfer preventing continuous pharmacy visits during study period.
4. Ophthalmology visit within 1 year prior to enrollment (verified by My Number Card or self-report)
5. Lack of consent capacity or absence at time of consent.
6. Declined participation.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Narumi |
| Middle name | |
| Last name | Kobayashi |
Organization
UNISMILE Co., Ltd.
Division name
UNISMILE Pharmacy Nasushiobara
Zip code
329-3156
Address
Tochigi ken Nasushiobara-shi hokyo 1-6-1
TEL
0287-65-4440
nasushiobara@unismile.co.jp
Public contact
Name of contact person
| 1st name | Narumi |
| Middle name | |
| Last name | Kobayashi |
Organization
UNISMILE Co., Ltd.
Division name
UNISMILE Pharmacy Nasushiobara
Zip code
329-3156
Address
Tochigi ken Nasushiobara-shi hokyo 1-6-1
TEL
0287-65-4440
Homepage URL
nasushiobara@unismile.co.jp
Sponsor or person
Institute
UNISMILE Co., Ltd. UNISMILE Pharmacy Nasushiobara
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Unismile Institutional Review Board
Address
Tokyo-to Chiyoda-ku Kanda neribei machi 68-banchi 1 muratayabiru 3-kai
Tel
03-5297-3277
jinzai@unismile.co.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 | 20 | 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 | 10 | Day |
Date of IRB
| 2025 | Year | 11 | Month | 19 | Day |
Anticipated trial start date
| 2025 | Year | 11 | Month | 21 | Day |
Last follow-up date
| 2026 | Year | 10 | Month | 12 | 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 | 20 | Day |
Last modified on
| 2025 | Year | 11 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068433
