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

Effectiveness of Educational Interventions to Reduce Concerns About Falling, Falls and Associated Outcomes Among Older Adults: a Randomized Controlled Trial

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

Study Overview

• Status: Not yet recruiting
• Conditions: Falls; Fall Prevention; Concerns About Falling
• Intervention / Treatment: Behavioral: Interactive Fall Prevention Education; Behavioral: Printed Educational Materials

Detailed Description

Previous studies and meta-analyses have shown that educational strategies for fall prevention are still underexplored and have produced inconsistent results, possibly due to the limited use of appropriate educational methods and approaches that effectively change older adults' perceptions and behaviors related to falls.

This study aims to investigate the effects of a six-week educational intervention using active learning methodologies on concern about falling in community-dwelling older adults compared to a control group. Our secondary objectives are to evaluate whether the educational intervention reduces fall events and near-fall events and improves knowledge and awareness related to fall prevention in older adults.

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.

Follow-up assessments will be conducted immediately after the intervention period (6 weeks), and at 3 months and 6 months after the intervention. Falls and near-falls will be monitored throughout the follow-up period using follow-up contacts.

• Study Type: Interventional
• Enrollment (Estimated): 102
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jordania L Almas, PT, MSc; Phone Number: +55 32 98875-0633; Email: jordaniaalmas@yahoo.com.br
• Study Contact Backup: Name: Alessandra LG Lucchetti, MD, PhD; Email: alessandra.lucchetti@ufjf.br

Study Locations

• Brazil
  • Minas Gerais
    • Juiz de Fora, Minas Gerais, Brazil, 36036900
      • School of Medicine, Federal University of Juiz de Fora
      • Contact: Alessandra LG Lucchetti; Phone Number: +55 32 2102-3841; Email: alessandra.lucchetti@ufjf.br
      • Contact: Giancarlo Lucchetti, MD, PhD; Phone Number: +55 32 2102-3841; Email: g.lucchetti@ufjf.br
      • Principal Investigator: Jordania L Almas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Interactive Fall Prevention Education; 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; 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
Active Comparator: Printed Educational Materials; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of participants with at least one fall	The proportion of participants who experience at least one fall during the follow-up period will be recorded using follow-up contacts	Baseline, 6 weeks, 3 months, and 6 months
Number of Falls	The total number of falls will be recorded during the follow-up period using follow-up contacts.	Baseline, 6 weeks, 3 months, and 6 months
Knowledge about fall prevention	Change in knowledge about fall prevention will be assessed using the Falls Risk Awareness Questionnaire (FRAQ-Brazil), which evaluates knowledge about fall risk factors, prevention strategies, and situations associated with fall risk. Higher scores indicate greater knowledge related to fall prevention.	Baseline, 6 weeks, 3 months, and 6 months
Fall risk awareness	Change in fall risk awareness will be assessed using the Falls Risk Awareness Questionnaire (FRAQ-Brazil), which evaluates participants' awareness and perception of fall risk factors and situations associated with falls	Baseline, 6 weeks, 3 months, and 6 months
Number of near-falls	The total number of near-falls during follow-up will be recorded using follow-up contacts. A near-fall will be defined as an event in which the participant slips, trips, or loses balance but is able to prevent coming to rest on the ground, floor, or lower level.	Baseline, 6 weeks, 3 months, and 6 months
Proportion of participants with at least one near-fall	The proportion of participants who experience at least one near-fall during follow-up will be recorded using follow-up contacts. A near-fall will be defined as an event in which the participant slips, trips, or loses balance but is able to prevent coming to rest on the ground, floor, or lower level.	Baseline, 6 weeks, 3 months, and 6 months

Collaborators and Investigators

• Sponsor: Federal University of Juiz de Fora

Study record dates

Study Major Dates

• Study Start (Estimated): April 15, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: March 31, 2026
• First Submitted That Met QC Criteria: March 31, 2026
• First Posted (Actual): April 7, 2026

Study Record Updates

• Last Update Posted (Actual): April 9, 2026
• Last Update Submitted That Met QC Criteria: April 6, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: older adults; clinical trial; falls; educational intervention; concerns of falling; active methods of teaching
• Other Study ID Numbers: UFJF-EDU-FALLS-26

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual participant data underlying the results reported in this study will be available upon reasonable request.
• IPD Sharing Time Frame: Beginning 6 months after publication of the primary results and ending 5 years after publication
• IPD Sharing Access Criteria: Access will be granted to researchers who provide a methodologically sound proposal. Requests should be directed to the principal investigator
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No