Tokyo, April 16 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061266) titled 'A Study on Support for Frailty Prevention Among Older Adults in the Community Provided by Community Pharmacies' on April 15.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Single blind -investigator(s) and assessor(s) are blinded
Control - No treatment
Primary Sponsor:
Institute - The University of Tokyo
Condition:
Condition - Frailty, Oral frailty
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - This study aims to investigate the effects of support activities for community-dwelling older adults using frailty and oral frailty screening items in community pharmacies on health awareness, lifestyle behaviors, and frailty-related outcomes. The study is intended to clarify the effectiveness of pharmacist-led frailty prevention interventions utilizing pharmacists professional expertise and to examine the feasibility of pharmacy-based support as part of an integrated community care system.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Study participants will receive frailty and oral frailty assessments, oral diadochokinesis measurement, handgrip strength measurement, calf circumference measurement, and feedback on the assessment results at the time of their pharmacy visit. In addition, when deemed necessary, pharmacists at the study pharmacies will provide frailty and oral frailty prevention support, including information on diet, exercise, social participation, and oral function training, as well as medication support and communication with the participants primary care physician and/or dentist. The intervention will be delivered primarily by pharmacy pharmacists, and each session is expected to require approximately 20 minutes.
Interventions/Control_2 - The control group will not receive feedback on evaluation results or support from pharmacists or other pharmacy staff. Information will be provided to the patients primary care physician or dentist only in cases of emergency.
Eligibility:
Age-lower limit - 65
years-old
=
Gender - Male and Female
Key inclusion criteria - The study population consists of elderly residents of the local community. The inclusion criteria are: (1) age 65 or older; (2) polypharmacy (five or more prescription medications); (3) not certified as requiring long-term care; and (4) having provided informed consent to participate in the study.
Key exclusion criteria - The exclusion criteria are as follows: (1) under 65 years of age; (2) taking fewer than five prescription medications; (3) individuals certified as requiring long-term care; and (4) those who do not provide informed consent for the study.
Target Size - 400
Recruitment Status:
Recruitment status - Open public recruiting
Date of protocol fixation - 2026 Year 03 Month 01 Day
Date of IRB - 2025 Year 09 Month 30 Day
Anticipated trial start date - 2026 Year 04 Month 01 Day
Last follow-up date - 2026 Year 12 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069949
Disclaimer: Curated by HT Syndication.