Tokyo, March 23 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060999) titled 'Effect of pharmacist-led educational intervention on switching to generic medicine among patients using brand-name medicines' on March 20.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Self control
Primary Sponsor:
Institute - Other
Condition:
Condition - Patients using brand-name medicines
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - This study aimed to investigate whether patients using brand-name medicines, who had limited knowledge and low perception of generic medicine, would switch from brand-name medicines to generic medicine following pharmacist-led educational intervention. Additionally, we compared the knowledge and perceptions of generic medicine before and after the intervention and assessed whether these findings contributed to an increase in the number of patients switching from brand-name medicines to generic medicine.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - In this study, the educational intervention consisted of pharmacists providing standardized explanations using pamphlets about generic medicine (GE) to patients who preferred brand-name medicines and allocating time to answer questions. The content covered GE's manufacturing approval processes, efficacy, quality, safety, advantages not present in brand-name medicines [e.g., improved bitterness and dosing convenience], economic benefits of using GE, the background of GE promotion policies, and fees related to patient preference for brand-name medicines. The standardized explanation and Q&A sessions were scheduled to take approximately 20 min. The intervention was scheduled for the second visit.
Eligibility:
Age-lower limit - 18
years-old
Gender - Male and Female
Key inclusion criteria - Patients who have provided informed consent to participate in this study
Patients who have previously used generic medicines
Patients aged 18 to 74 who are using one or more brand-name medicines of their own request
Key exclusion criteria - Patients who wish to use generic medicines for all prescribed medications
Patients who have no prior experience with generic medicines
Patients who were unable to complete all procedures for VISIT 1 and 2 in accordance with the protocol
Patients taking medications to improve cognitive function who were deemed unsuitable due to a lack of understanding regarding the medications
Patients taking psychotropic medications, such as antidepressants or antipsychotics, who were deemed unsuitable due to the high likelihood of causing excessive distress
Target Size - 50
Recruitment Status:
Recruitment status - No longer recruiting
Date of protocol fixation - 2025 Year 02 Month 07 Day
Date of IRB - 2025 Year 02 Month 07 Day
Anticipated trial start date - 2025 Year 03 Month 01 Day
Last follow-up date - 2028 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069805
Disclaimer: Curated by HT Syndication.