NCT06961799

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. 1.To validate a new, comprehensive, multifactorial screeningsintrument to predict the risk on falls in community dwelling, Belgian, older adults (\>65years or older).
  2. 2.To optimize the new, comprehensive, multifactorial screeningsintrument and to specify correct cut off scores

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
228

participants targeted

Target at P75+ for all trials

Timeline
7mo left

Started Mar 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress67%
Mar 2025Dec 2026

Study Start

First participant enrolled

March 20, 2025

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

April 18, 2025

Completed
20 days until next milestone

First Posted

Study publicly available on registry

May 8, 2025

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

May 8, 2025

Status Verified

April 1, 2025

Enrollment Period

1.7 years

First QC Date

April 18, 2025

Last Update Submit

May 5, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

    Baseline

  • Number of falls among Belgian, community dwelling older adults

    The number of falls measured with a monthly falls calender

    1 year

Secondary Outcomes (9)

  • Depression

    Baseline

  • Fear of falling

    Baseline

  • Functional mobility

    Baseline

  • Executive cognitive capacity

    Baseline

  • Static Balance

    Baseline

  • +4 more secondary outcomes

Interventions

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.

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Community dwelling, belgian older adults

You may qualify if:

  • years 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.

You may not qualify if:

  • \<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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ghent University

Ghent, Belgium, 9000, Belgium

RECRUITING

Study Officials

  • Dirk Cambier, Prof. Dr.

    University Ghent

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ellis Rommers, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 18, 2025

First Posted

May 8, 2025

Study Start

March 20, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

May 8, 2025

Record last verified: 2025-04

Locations