Tokyo, July 25 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062329) titled 'An Empirical Study of Nudge-Based Interventions to Enhance Trust in Generic Drugs and Promote Their Use' on July 24.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Single blind -participants are blinded
Control - Active
Primary Sponsor:
Institute - Institute for Health Economics and Policy
Condition:
Condition - No specific condition
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - This study aimed to assess whether loss- and gain-framed nudges highlighting the price difference under Japan's cost-sharing policy for long-listed drugs increased intention to use generic drugs immediately after the intervention and self-reported generic drug uptake two months later, compared with a neutral control message. The study focused on adults who reported not using generic drugs or being unsure whether they used them and who had low trust in their safety and effectiveness. We also examined whether these effects differed by sex.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - At Wave 1 (15-19 May 2025), after receiving the common standardized policy explanation, participants viewed the following loss-framed nudge message once online: "If you choose a brand-name drug instead of a generic drug, you will be required to pay a special fee equal to one-quarter of the price difference between the two drugs. As a result, your out-of-pocket medication costs may increase by approximately 30-50%." No additional intervention was provided at Wave 2.
Interventions/Control_2 - At Wave 1 (15-19 May 2025), after receiving the common standardized policy explanation, participants viewed the following gain-framed nudge message once online: "If you choose a generic drug instead of a brand-name drug, the special fee equal to one-quarter of the price difference between the two drugs will be waived. As a result, your out-of-pocket medication costs may decrease by approximately 20-30%." No additional intervention was provided at Wave 2.
Eligibility:
Age-lower limit - 18
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - Participants were eligible if they met all of the following criteria: (1) were aged 18 years or older; (2) were able to choose a generic drug; (3) reported that they were not currently using generic drugs or were unsure whether they were using them; (4) had low trust in generic drugs, defined as a score of 3 or lower for both the statements "Generic drugs are safe" and "Generic drugs are effective" on five-point Likert scales ranging from 1 ("strongly disagree") to 5 ("strongly agree"); and (5) provided electronic informed consent.
Key exclusion criteria - Participants were excluded if they met any of the following criteria: (1) were younger than 18 years; (2) were unable to choose a generic drug; (3) reported that they were currently using generic drugs; (4) scored 4 or higher on either the perceived safety or perceived effectiveness item and therefore did not meet the definition of low trust in generic drugs; or (5) did not provide electronic informed consent.
Target Size - 2500
Recruitment Status:
Recruitment status - Completed
Date of protocol fixation - 2025 Year 03 Month 20 Day
Date of IRB - 2025 Year 04 Month 14 Day
Anticipated trial start date - 2025 Year 05 Month 15 Day
Last follow-up date - 2025 Year 07 Month 19 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071327
Disclaimer: Curated by HT Syndication.