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NCT Number: NCT07515053

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

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

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Key information

Conditions

Concerns About Falling Fall Prevention Falls

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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.

Primary outcomes

  1. Concern about Falling

    Time frame: Baseline, 6 weeks, 3 months, and 6 months

    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

Secondary outcomes

  1. Proportion of participants with at least one fall

    Time frame: Baseline, 6 weeks, 3 months, and 6 months

    The proportion of participants who experience at least one fall during the follow-up period will be recorded using follow-up contacts

  2. Number of Falls

    Time frame: Baseline, 6 weeks, 3 months, and 6 months

    The total number of falls will be recorded during the follow-up period using follow-up contacts.

  3. Knowledge about fall prevention

    Time frame: Baseline, 6 weeks, 3 months, and 6 months

    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.

  4. Fall risk awareness

    Time frame: Baseline, 6 weeks, 3 months, and 6 months

    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

  5. Number of near-falls

    Time frame: Baseline, 6 weeks, 3 months, and 6 months

    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.

  6. Proportion of participants with at least one near-fall

    Time frame: Baseline, 6 weeks, 3 months, and 6 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Alessandra LG Lucchetti, MD, PhD

CONTACT

[email protected]

Jordania L Almas, PT, MSc

CONTACT

[email protected]

+55 32 98875-0633

Sponsors and collaborators

Lead sponsor

Federal University of Juiz de Fora

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 7, 2026
Registry last updated
Apr 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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