Tokyo, Nov. 21 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059840) titled 'An Exploratory Study on the Impact of Ophthalmology Visit Recommendations by Community Pharmacists for Diabetic Patients' on Nov. 20.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Open -no one is blinded Control - Active

Primary Sponsor: Institute - UNISMILE Co., Ltd. UNISMILE Pharmacy Nasushiobara

Condition: Condition - Diabetes mellitus Classification by malignancy - Others Genomic information - NO

Objective: 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

Intervention: 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.

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 Size - 60

Recruitment Status: 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

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068433

Disclaimer: Curated by HT Syndication.