Skip to main content
Clinical Trials/NCT07515053
NCT07515053
Not yet recruiting
Not Applicable

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

Federal University of Juiz de Fora1 site in 1 country102 target enrollmentStarted: April 15, 2026Last updated:

Overview

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Federal University of Juiz de Fora
Enrollment
102
Locations
1
Primary Endpoint
Concern about Falling

Overview

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

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Single (Investigator)

Eligibility Criteria

Ages
60 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

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.

Intervention: Printed Educational Materials (Behavioral)

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).

Intervention: Interactive Fall Prevention Education (Behavioral)

Outcomes

Primary Outcomes

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

  • 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)
  • Proportion of participants with at least one near-fall(Baseline, 6 weeks, 3 months, and 6 months)

Investigators

Sponsor
Federal University of Juiz de Fora
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Alessandra Lamas Granero Lucchetti

Associate Professor

Federal University of Juiz de Fora

Study Sites (1)

Loading locations...

Similar Trials