UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061266 |
|---|---|
| Receipt number | R000069949 |
| Scientific Title | A Study on Support for Frailty Prevention Among Older Adults in the Community Provided by Community Pharmacies |
| Date of disclosure of the study information | 2026/04/15 |
| Last modified on | 2026/04/15 11:14:34 |
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Basic information
Public title
A Study on Support for Frailty Prevention Among Older Adults in the Community Provided by Community Pharmacies
Acronym
A Study on Support for Frailty Prevention Among Older Adults in the Community Provided by Community Pharmacies
Scientific Title
A Study on Support for Frailty Prevention Among Older Adults in the Community Provided by Community Pharmacies
Scientific Title:Acronym
A Study on Support for Frailty Prevention Among Older Adults in the Community Provided by Community Pharmacies
Region
| Japan |
Condition
Condition
Frailty, Oral frailty
Classification by specialty
| Geriatrics | Rehabilitation medicine | Dental medicine |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
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
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Frailty (Eleven-Check Questionnaire), oral frailty (OF-5 Questionnaire), grip strength, calf circumference, oral diadokinesis
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
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.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 65 | years-old | <= |
Age-upper limit
| 100 | 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 sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Katsuya |
| Middle name | |
| Last name | Iijima |
Organization
The University of Tokyo
Division name
Institute of Gerontology
Zip code
113-8656
Address
Room 706, Building 8, Faculty of Engineering, 7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
0358411661
iijima@iog.u-tokyo.ac.jp
Public contact
Name of contact person
| 1st name | Tomoki |
| Middle name | |
| Last name | Tanaka |
Organization
The University of Tokyo
Division name
Institute of Gerontology
Zip code
113-8656
Address
Room 709, Building 8, Faculty of Engineering, 7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
08041837022
Homepage URL
tmk-tanaka@iog.u-tokyo.ac.jp
Sponsor or person
Institute
The University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
Aeon Co., Ltd. Joint Research Grant
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The University of Tokyo
Address
7-3-1 Hongo, Bunkyo Ward, Tokyo
Tel
-
lifescience.adm@gs.mail.u-tokyo.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 04 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
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 |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 04 | Month | 15 | Day |
Last modified on
| 2026 | Year | 04 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069949
