Aged 65 Years or OlderNCT06961799
Validating a Multifactorial Algorithm to Predict Fall Risk in Community Dwelling Older Persons Aged 65 Years or Older
An observational study of Aged 65 Years or Older and Community Dwelling Older Adults, run by University Ghent at 1 site in Belgium.
Trial summary
Falls in older adults have an annual incidence between 23 and 34% for persons of 65 years and older. The lack of transfer of promising research results on falls prevention to daily practice may have several explanations. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aged 65 Years or Older, Community Dwelling Older Adults, Falls Risk
- What is being tested?
- Multifactorial algorithm to predict fall risk
- How many people
- 228 participants
- Where
- 1 siteBelgium
- Study dates
- 20 Mar 2025to Dec 2026
- Phase
- Observational
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: Community dwelling, belgian older adults
Who may be able to join
- 65years or older
- community dwellers
- absence of surgery or exacerbation of symptoms in the last 6 months
- ability to stand and walk independently (alone), possibly with an walking aid.
Who cannot join
- <65 years of age
- surgery within the previous 6 months affecting gait and mobility
- exacerbation of symptoms coming from a diagnosed disease
- older adults with insufficient (language) comprehension to complete the tests and questionnaires
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Falls in older adults have an annual incidence between 23 and 34% for persons of 65 years and older. The lack of transfer of promising research results on falls prevention to daily practice may have several explanations. One of the first concerns for that matter may be a valid and sensitive selection of the persons at risk who are eligible for fall prevention interventions
Goals of the prospective obeservational study:
Read more
- To validate a new, comprehensive, multifactorial screeningsintrument to predict the risk on falls in community dwelling, Belgian, older adults (>65years or older).
- To optimize the new, comprehensive, multifactorial screeningsintrument and to specify correct cut off scores
Researchers will compare the data of the accuracy of new algorithm with the current Belgian policy.
Participants will participate in a one-time testing moment, where they will be asked some questions about general characteristics and medical history, followed by two questionnaire and seven physical tests . Based on this data, their fall risk will be assessed. In the year that follows, the older person's fall behavior will be monitored with a monthly falls calender. Participant will be asked to fill out these calenders everyday ('Did you fall today?' YES/NO) and send them at the end of each month to the researchers, digitally or postal.
Read the detailed description
Two questionnaires:
- Geriatric Depression Scale - 16
- Falls Efficacy Scale - International
Seven physical tests:
- Timed Up and Go
- Times Up and Go with cognitive dual task (100 (repeatedly) minus 3)
- Single Limb Stance
- 5x Sit to Stand
- 4meter Gait Speed
- Tinetti
- Four Balance Test
- Conditions
- Aged 65 Years or Older, Community Dwelling Older Adults, Falls Risk, Falls (Accidents) in Old Age
- Being tested
- Multifactorial algorithm to predict fall risk
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multifactorial algorithm to predict fall riskDiagnostic test
In this new multifactorial algorithm we will add baseline data (personal characteristics, medical history, and physical and psychological measurements) to predict an older adults risk on falls. The accuracy of this new model will be tested with a 1-year follow up on falls.
The new algorithm is inspired by the study of Lusardi et al. (2017): Lusardi MM, Fritz S, Middleton A, Allison L, Wingood M, Phillips E, Criss M, Verma S, Osborne J, Chui KK. Determining Risk of Falls in Community Dwelling Older Adults: A Systematic Review and Meta-analysis Using Posttest Probability. J Geriatr Phys Ther. 2017 Jan/Mar;40(1):1-36. doi: 10.1519/JPT.0000000000000099. PMID: 27537070; PMCID: PMC5158094.
What is being measured
The primary outcome is the main question the study is designed to answer.
Conducted analysis of integraded tests
Fall risk calculated with the new multifactorial algorithm based on:
- general, personal characteristics
- medical history
- physical measurements
- self reported questionnaires
Measured: Baseline
Number of falls among Belgian, community dwelling older adults
The number of falls measured with a monthly falls calender
Measured: 1 year
Secondary outcomes (9)
Depression
Measured with the Geriatric Depression Scale (GDS-16)
Measured: Baseline
Fear of falling
Measured with the Falls Efficacy Scale (FES-I)
Measured: Baseline
Functional mobility
Measured with the Timed Up and Go (seconds)
Measured: Baseline
Executive cognitive capacity
Measured with the Timed Up and Go in combination with a cognitive dual task (100-3-3-3-...) (seconds)
Measured: Baseline
Static Balance
Measured with the Single Leg stance (seconds)
Measured: Baseline
Strength of the lower limbs
Measured with the 5x Sit to Stand (second)
Measured: Baseline
Gait speed
Measured with the 4m Gait Speed (m/s)
Measured: Baseline
Static and dynamic balance
Measured with the Tinetti: Performance-Oriented Mobility Assessment
Measured: Baseline
Static Balance
Measured with the 4 balance test
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2025
- Study start20 Mar 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aged 65 Years or OlderStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 228 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dirk Cambier, Prof. Dr., Principal investigator, University Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06961799
- Sponsor's protocol ID
- ONZ-2024-0584
- Status last verified
- Apr 2025
- First submitted
- 18 Apr 2025
- Last updated
- 8 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validating a Multifactorial Algorithm to Predict Fall Risk in Community Dwelling Older Persons Aged 65 Years or Older
- ClinicalTrials.gov ID
- NCT06961799
- Acronym / sponsor ID
- ONZ-2024-0584
- Conditions
- Aged 65 Years or Older, Community Dwelling Older Adults, Falls Risk, Falls (Accidents) in Old Age
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 228 participants (estimated)
- Lead sponsor
- University GhentUniversity, hospital or other
- Study start
- 20 Mar 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 8 May 2025 (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.
Falls in older adults have an annual incidence between 23 and 34% for persons of 65 years and older. The lack of transfer of promising research results on falls prevention to daily practice may have several explanations. One of the first concerns for that matter may be a valid and sensitive selection of the persons at risk who are eligible for fall prevention interventions
Goals of the prospective obeservational study:
- To validate a new, comprehensive, multifactorial screeningsintrument to predict the risk on falls in community dwelling, Belgian, older adults (>65years or older).
- To optimize the new, comprehensive, multifactorial screeningsintrument and to specify correct cut off scores
Researchers will compare the data of the accuracy of new algorithm with the current Belgian policy.
Participants will participate in a one-time testing moment, where they will be asked some questions about general characteristics and medical history, followed by two questionnaire and seven physical tests . Based on this data, their fall risk will be assessed. In the year that follows, the older person's fall behavior will be monitored with a monthly falls calender. Participant will be asked to fill out these calenders everyday ('Did you fall today?' YES/NO) and send them at the end of each month to the researchers, digitally or postal.
Detailed description
Two questionnaires:
- Geriatric Depression Scale - 16
- Falls Efficacy Scale - International
Seven physical tests:
- Timed Up and Go
- Times Up and Go with cognitive dual task (100 (repeatedly) minus 3)
- Single Limb Stance
- 5x Sit to Stand
- 4meter Gait Speed
- Tinetti
- Four Balance Test
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Community dwelling, belgian older adults
Key inclusion criteria (4 listed)
- 65years or older
- community dwellers
- absence of surgery or exacerbation of symptoms in the last 6 months
- ability to stand and walk independently (alone), possibly with an walking aid.
Key exclusion criteria (4 listed)
- <65 years of age
- surgery within the previous 6 months affecting gait and mobility
- exacerbation of symptoms coming from a diagnosed disease
- older adults with insufficient (language) comprehension to complete the tests and questionnaires
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 |
|---|---|---|
| Multifactorial algorithm to predict fall riskIn this new multifactorial algorithm we will add baseline data (personal characteristics, medical history, and physical and psychological measurements) to predict an older adults risk on falls. The accuracy of this new model will be tested with a 1-year follow up on falls. The new algorithm is inspired by the study of Lusardi et al. (2017): Lusardi MM, Fritz S, Middleton A, Allison L, Wingood M, Phillips E, Criss M, Verma S, Osborne J, Chui KK. Determining Risk of Falls in Community Dwelling Older Adults: A Systematic Review and Meta-analysis Using Posttest Probability. J Geriatr Phys Ther. 2017 Jan/Mar;40(1):1-36. doi: 10.1519/JPT.0000000000000099. PMID: 27537070; PMCID: PMC5158094. | Diagnostic test | – |
Primary outcome
Conducted analysis of integraded tests
Time frame: Baseline
Fall risk calculated with the new multifactorial algorithm based on: * general, personal characteristics * medical history * physical measurements * self reported questionnaires
Number of falls among Belgian, community dwelling older adults
Time frame: 1 year
The number of falls measured with a monthly falls calender
9 secondary outcomes
Depression
Time frame: Baseline
Fear of falling
Time frame: Baseline
Functional mobility
Time frame: Baseline
Executive cognitive capacity
Time frame: Baseline
Static Balance
Time frame: Baseline
Strength of the lower limbs
Time frame: Baseline
Gait speed
Time frame: Baseline
Static and dynamic balance
Time frame: Baseline
Static Balance
Time frame: Baseline
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 8 May 2025.
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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.
Dirk Cambier, Prof. Dr. principal investigator
University Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aged 65 Years or Older and Community Dwelling Older Adults, run by University Ghent at 1 site in Belgium.
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 4 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: looking for participants now, as of the sponsor's last update on 8 May 2025. 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 Belgium. 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 Ellis Rommers, PhD (+32 9 332 46 57, ellis.rommers@ugent.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Conducted analysis of integraded tests (time frame: Baseline). The study lists 2 primary outcomes in all. 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 8 May 2025; AzTrials last refreshed its copy on 27 Oct 2026.