Concerns About FallingNCT07515053
Educational Interventions to Reduce Concerns About Falling, Falls and Associated Outcomes Among Older Adults
A study testing Interactive Fall Prevention Education and Printed Educational Materials in people with Concerns About Falling and Falls, run by Federal University of Juiz de Fora at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Concerns About Falling, Falls, Fall Prevention
- What is being tested?
- Interactive Fall Prevention Education and Printed Educational Materials
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteBrazil
- Study dates
- 15 Apr 2026to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Alessandra LG Lucchetti, MD, PhD contact
Brazil1 site
School of Medicine, Federal University of Juiz de Fora
Juiz de Fora, Minas Gerais, 36036900
Alessandra LG Lucchetti, +55 32 2102-3841, alessandra.lucchetti@ufjf.br
Giancarlo Lucchetti, MD, PhD, +55 32 2102-3841, g.lucchetti@ufjf.br
About this study
Official title: 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:
Read more
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
Read the 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.
- Conditions
- Concerns About Falling, Falls, Fall Prevention
- Being tested
- Interactive Fall Prevention Education, Printed Educational Materials
- Keywords
- concerns of falling, falls, older adults, clinical trial, educational intervention, active methods of teaching
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interactive Fall Prevention EducationBehavioural
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 MaterialsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Behavioral: Printed Educational Materials |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline, 6 weeks, 3 months, and 6 months
Secondary outcomes (6)
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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: Baseline, 6 weeks, 3 months, and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2026
- Study start15 Apr 2026 (estimated)
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Concerns About FallingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of Juiz de Fora
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alessandra Lamas Granero Lucchetti, Federal University of Juiz de Fora
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07515053
- Sponsor's protocol ID
- UFJF-EDU-FALLS-26
- Status last verified
- Apr 2026
- First submitted
- 31 Mar 2026
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the results reported in this study will be available upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Educational Interventions to Reduce Concerns About Falling, Falls and Associated Outcomes Among Older Adults: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07515053
- Acronym / sponsor ID
- UFJF-EDU-FALLS-26
- Conditions
- Concerns About Falling, Falls, Fall Prevention
- Keywords
- concerns of falling, falls, older adults, clinical trial, educational intervention, active methods of teaching
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Federal University of Juiz de ForaUniversity, hospital or other
- Study start
- 15 Apr 2026 (estimated)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 7 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Interactive Fall Prevention Education | Experimental | Behavioral: Interactive Fall Prevention EducationParticipants will receive a group-based interactive educational program on fall prevention delivered over six sessions (delivered once a week). |
| Printed Educational Materials | Active comparator | Behavioral: Printed Educational MaterialsThe control group will receive a lecture on general healthy aging (not related to falls) and printed fall-related educational leaflets. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interactive Fall Prevention EducationArm/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 | Behavioural | Interactive Fall Prevention Education |
| Printed Educational MaterialsThe 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. | Behavioural | Printed Educational Materials |
Primary outcome
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
6 secondary outcomes
Proportion of participants with at least one fall
Time frame: Baseline, 6 weeks, 3 months, and 6 months
Number of Falls
Time frame: Baseline, 6 weeks, 3 months, and 6 months
Knowledge about fall prevention
Time frame: Baseline, 6 weeks, 3 months, and 6 months
Fall risk awareness
Time frame: Baseline, 6 weeks, 3 months, and 6 months
Number of near-falls
Time frame: Baseline, 6 weeks, 3 months, and 6 months
Proportion of participants with at least one near-fall
Time frame: Baseline, 6 weeks, 3 months, and 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the results reported in this study will be available upon reasonable request.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alessandra LG Lucchetti, MD, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interactive Fall Prevention Education and Printed Educational Materials in people with Concerns About Falling and Falls, run by Federal University of Juiz de Fora at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jordania L Almas, PT, MSc (+55 32 98875-0633, jordaniaalmas@yahoo.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concern about Falling (time frame: Baseline, 6 weeks, 3 months, and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2026.