Educational Interventions to Reduce Concerns About Falling, Falls and Associated Outcomes Among Older Adults

NCT07515053 | Not Yet Recruiting

• 1 other identifier: UFJF-EDU-FALLS-26
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn if an active educational intervention (using interactive and active methods of teaching) works better than the traditional lecture teaching to reduce concerns of falling, falls and other health problems among older adults. The main questions it aims to answer are: Does having more dynamic interactive educational interventions can performed better than using just traditional lectures? Are these interventions able to reduce concerns of falling, fears and other outcomes among older adults? Participants will: Receive one of the interventions (active/interactive or traditional lecture) Answer self-report questionnaires related to concerns of falls and falls Perform some fall-related tests Be followed for 3 and 6 months

Conditions

Concerns About Falling; Falls; Fall Prevention

Keywords

concerns of falling; falls; older adults; clinical trial; educational intervention; active methods of teaching

Outcome Measures

Primary Outcomes (1)

• Concern about Falling

  Concern about falling will be measured using the Falls Efficacy Scale International (FES-I). Scores range from 16 to 64, with higher scores indicating greater concern about falling

  Baseline, 6 weeks, 3 months, and 6 months

Secondary Outcomes (6)

• Proportion of participants with at least one fall

  Baseline, 6 weeks, 3 months, and 6 months

• Number of Falls

  Baseline, 6 weeks, 3 months, and 6 months

• Knowledge about fall prevention

  Baseline, 6 weeks, 3 months, and 6 months

• Fall risk awareness

  Baseline, 6 weeks, 3 months, and 6 months

• Number of near-falls

  Baseline, 6 weeks, 3 months, and 6 months

Study Arms (2)

Interactive Fall Prevention Education

EXPERIMENTAL

Participants will receive a group-based interactive educational program on fall prevention delivered over six sessions (delivered once a week).

Behavioral: Interactive Fall Prevention Education

Printed Educational Materials

ACTIVE COMPARATOR

The control group will receive a lecture on general healthy aging (not related to falls) and printed fall-related educational leaflets.

Behavioral: Printed Educational Materials

Interventions

Interactive Fall Prevention Education BEHAVIORAL

Arm/Group Experimental: Interactive Fall Prevention Education Arm Description: The intervention will be carried out in groups of 12 to 17 participants. There will be six educational sessions (delivered once a week) focusing on the following fall prevention topics: (1) impact of falls and aging-related changes; (2) identification of fall risk and protective factors; (3) home safety and environmental modifications; (4) fall prevention strategies; (5) concern about falling and what to do after a fall; and (6) adoption of safe behaviors and fall prevention strategies. At each session, participants will receive printed educational materials summarizing the main topics discussed (these materials are the same offered to the control group). The intervention will use interactive and active teaching methods, including group discussions, games, simulated scenarios, problem-solving activities, and practical examples. The educational content will be based on fall prevention guidelines from the Cent

Interactive Fall Prevention Education

Printed Educational Materials BEHAVIORAL

The control group will receive a lecture on general healthy aging (not related to falls) and printed educational leaflets covering the same six fall prevention topics addressed in the interactive educational intervention, including fall risk factors, home safety, prevention strategies, and what to do after a fall. The educational content will be delivered only through printed materials and not through interactive sessions.

Printed Educational Materials

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants with 60 years old or older
• At least one fall in the previous 12 months.
• A minimum score for the Mini-Mental State Examination (MMSE) according to educational level: Illiterate: 13, 1 to 7 years of schooling: 18, More than 7 years of schooling: 26

You may not qualify if:

• MMSE score below the minimum cutoff for educational level.
• Current participation in regular physical therapy treatment.
• Presence of severe neurological, motor, and/or visual impairments that may interfere with participation in the study.
• Refusal or inability to provide informed consent

Sponsors & Collaborators

• Federal University of Juiz de Fora: lead

Study Sites (1)

School of Medicine, Federal University of Juiz de Fora

Juiz de Fora, Minas Gerais, 36036900, Brazil

Location

Central Study Contacts

Jordania L Almas, PT, MSc

CONTACT

+55 32 98875-0633; jordaniaalmas@yahoo.com.br

Alessandra LG Lucchetti, MD, PhD

CONTACT

alessandra.lucchetti@ufjf.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: This is a randomized, parallel-group trial in which participants will be allocated to either an interactive educational intervention group (active methods of teaching) or a control group receiving the same educational content through printed materials and a lecture on general healthy aging. Outcomes will be assessed at baseline and follow-up timepoints.

Study Record Dates

• First Submitted: March 31, 2026
• First Posted: April 7, 2026
• Study Start: April 15, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 6 months after publication of the primary results and ending 5 years after publication
• Access Criteria: Access will be granted to researchers who provide a methodologically sound proposal. Requests should be directed to the principal investigator

Locations

BR (1)