臨床研究等提出・公開システム

A Preliminary Study on the Feasibility of a Fall Prevention Intervention Using Leaflets Based on the 'Continuous Plus 10' Concept for Community-Dwelling Older Adults.

Fall Prevention Intervention Using Leaflets Based on the 'Continuous Plus 10'

Takegami Yasuhiko

Nagoya university

1-1-20, Daiko-minami, Higashi-ku, Nagoya

takegami.yasuhiko.k3@f.mail.nagoya-u.ac.jp

Takegami Yasuhiko

Nagoya university

1-1-20, Daiko-minami, Higashi-ku, Nagoya

+81-52-719-1504

takegami.yasuhiko.k3@f.mail.nagoya-u.ac.jp

Pending

July. 15, 2025

Interventional

non-randomized controlled trial

open(masking not used)

active control

parallel assignment

prevention purpose

Individuals participating in the annual Togo Town community health check-up ("Iki-iki-do Check") during the fiscal year of the study.

Aged 65 years or older at the time of providing informed consent.

Resident of Togo Town.

Able to fully understand the purpose and procedures of the study and provide written informed consent voluntarily.

Able to read and write Japanese and understand the content of the mailed leaflets.

Willing and able to cooperate with the 1-year follow-up survey (e.g., FRI-5 re-evaluation).

Presence of a severe physical or psychiatric illness that, in the investigator's judgment, would interfere with study participation or the completion of follow-up assessments (e.g., FRI-5 re-evaluation).

Presence of significant cognitive impairment that, in the investigator's judgment, compromises the ability to understand the study and provide informed consent.

Presence of severe visual or hearing impairment that would prevent the participant from understanding or utilizing the content of the leaflets, even with corrective aids.

Individuals who plan to move out of Togo Town during the study period or are otherwise deemed unlikely to complete the 1-year follow-up.

Residing in a long-term care facility (e.g., special nursing home for the elderly, long-term care health facility, long-term care medical facility, etc.).

Receipt of continuous individual or group guidance on fall prevention with content similar to that provided in this study within the past 6 months.

Any other condition that the Principal Investigator or a co-investigator deems would make the individual unsuitable for participation in the study.

Both

Falls in older adults

For one year, a co-investigator will mail monthly leaflets, which provide information on fall prevention based on the "Continuous Plus 10" concept, to participants who wish to receive them (Intervention group: Group A). Participants who do not wish to receive the leaflets will be designated as the control group (Group B: Non-leaflet group).

Fall

Education

R29.6

Health education

Primary Outcome:

Change in the Fall Risk Index-5 (FRI-5) score from baseline to 1 year post-intervention.

Secondary Outcomes:

Incidence of falls and fragility fractures during the intervention period.

Acceptability of and satisfaction with the leaflet intervention, and adherence to recommended fall prevention behaviors.

Change in cognitive function, as assessed by the Mini Mental State Examination (MMSE).

Change in anxiety about developing dementia, as assessed by the Dementia Worry Assessment Scale (DWAS).

+81-52-744-2479

July. 15, 2025

No

none