Clinical trial NCT06961799: Validating a Multifactorial Algorithm to Predict Fall Risk in Community Dwelling Older Persons Aged 65 Years or Older
Official title: Validating a Multifactorial Algorithm to Predict Fall Risk in Community Dwelling Older Persons Aged 65 Years or Older
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Aged 65 Years or Older
Community Dwelling Older Adults
Falls Risk
Falls (Accidents) in Old Age
Lead sponsor: University Ghent
Sponsor class: OTHER
First posted: 2025-05-08
Enrollment: 228
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Community dwelling, belgian older adults

Brief 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. 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:

1. To validate a new, comprehensive, multifactorial screeningsintrument to predict the risk on falls in community dwelling, Belgian, older adults (\>65years or older).
2. 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:

1. Geriatric Depression Scale - 16
2. Falls Efficacy Scale - International

Seven physical tests:

1. Timed Up and Go
2. Times Up and Go with cognitive dual task (100 (repeatedly) minus 3)
3. Single Limb Stance
4. 5x Sit to Stand
5. 4meter Gait Speed
6. Tinetti
7. Four Balance Test

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* \<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

Primary outcomes:
measure: Conducted analysis of integraded tests
timeFrame: Baseline
measure: Number of falls among Belgian, community dwelling older adults
timeFrame: 1 year
Secondary outcomes:
measure: Depression
timeFrame: Baseline
measure: Fear of falling
timeFrame: Baseline
measure: Functional mobility
timeFrame: Baseline
measure: Executive cognitive capacity
timeFrame: Baseline
measure: Static Balance
timeFrame: Baseline
measure: Strength of the lower limbs
timeFrame: Baseline
measure: Gait speed
timeFrame: Baseline
measure: Static and dynamic balance
timeFrame: Baseline
measure: Static Balance
timeFrame: Baseline
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Ghent University
Study officials:
affiliation: University Ghent
name: Dirk Cambier, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: