Tokyo, Nov. 6 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059655) titled 'Development and Evaluation of a Leaflet to Support Patients in Reviewing Their Medications Together with Healthcare Providers' on Nov. 5.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Open -no one is blinded
Control - Active
Primary Sponsor:
Institute - St. Marianna University School of Medicine
Condition:
Condition - Patients with polypharmacy
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - This study aims to establish the foundation of the MPEG Plus program, which supports autonomous decision-making by patients with polypharmacy and promotes medication review. To achieve this, a patient leaflet based on nudge theory will be developed to encourage patients to consult healthcare providers about their medications, and its acceptability and usefulness will be evaluated through an online randomized controlled trial involving both patients and healthcare professionals.
Basic objectives2 - Others
Intervention:
Interventions/Control_1 - Viewing of a Medication Review leaflet designed based on nudge theory
Interventions/Control_2 - Viewing of a general leaflet designed based on the Health Belief Model
Eligibility:
Age-lower limit - 18
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - [Online RCT for Patients]
Adults (aged 18 years or older) who are registered monitors of Macromill Inc. and are prescribed five or more regular medications by a healthcare institution, and who have provided voluntary informed consent to participate in this study after receiving sufficient explanation about its purpose and content.
[Online RCT for Healthcare Professionals]
Licensed physicians or pharmacists who have provided voluntary informed consent to participate in this study after receiving sufficient explanation about its purpose and content.
Key exclusion criteria - Individuals deemed inappropriate for inclusion by the principal investigator
Target Size - 400
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 10 Month 31 Day
Date of IRB - 2025 Year 10 Month 31 Day
Anticipated trial start date - 2025 Year 12 Month 01 Day
Last follow-up date - 2027 Year 02 Month 28 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068238
Disclaimer: Curated by HT Syndication.