NCT06142864

Brief Summary

In France, falls among the elderly lead to more than 100,000 hospitalisations and more than 10,000 deaths each year. A French study published in October 2020 highlighted 5 profiles of older people who fall. However, this study is only based on falls of people over 65 years of age that required hospitalisation. In haemodialysis patients, several studies have shown that the incidence of falls ranges from 1.18 to 1.6 falls/patient/year. This population is more likely to be frail, suffer from sarcopenia, have reduced functional capacity and be polymedicated, all of which are associated with an increased risk of falls. Few studies have focused on falls in young patients. In one American study, where the population was predominantly African American (about 62%), 28.4% of patients had at least one fall during follow-up. The number of falls in people aged 45-64 years was similar to that in people aged over 75 years. In clinical practice, few patients report the occurrence of falls other than those leading to an emergency department visit or hospitalisation, and these falls are even less likely to be recorded in the medical record. To our knowledge, there are few or no data on falls in haemodialysis patients of all ages in a French population. This lack of knowledge is partly due to an underestimation of the problem associated with under-reporting. A study of the prevalence of falls in a haemodialysis population of all ages is therefore necessary to determine whether there is an interest in implementing a collective and/or individual prevention programme, possibly depending on the identified risk factors for falls.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2024

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

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

First Submitted

Initial submission to the registry

November 15, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 22, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2024

Completed
Last Updated

November 22, 2023

Status Verified

November 1, 2023

Enrollment Period

4 months

First QC Date

November 15, 2023

Last Update Submit

November 15, 2023

Conditions

Keywords

haemodialysisfallshaemodialysis patients

Outcome Measures

Primary Outcomes (1)

  • mechanical fall.

    The occurrence of a mechanical fall in the last 6 months (occurrence yes or not) will be sought by specific interrogation of the patient. Mechanical falls are defined as falling or slipping on the ground or below the starting position of the subject, involuntarily or awkwardly. Falls related to a violent flare-up, loss of consciousness, sudden onset of paralysis as in a stroke or seizure of epilepsy are not considered.

    Day 0

Study Arms (2)

-"Case" patients

-"Case" patients will be patients reporting at least one fall in the last 6 months.

Other: Data collection

-"Control" patients

-"Control" patients will be patients reporting no fall in the last 6 months.

Other: Data collection

Interventions

Data collection

-"Case" patients-"Control" patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

haemodialysis patients

You may qualify if:

  • aged more than 18
  • hemodialysis for more than 3 months,
  • Who live at home,
  • Who speak and understand French
  • Who agree to participate in the study.

You may not qualify if:

  • aged less than 18
  • Living in an institution,
  • Who are protected by law (guardianship, curatorship, safeguard of justice),
  • Who do not speak and/or understand French
  • Who have cognitive problems that prevent them from understanding the specific questions for the study.
  • People permanently bedridden

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ufr Medecine Urca

Reims, 51100, France

Location

Université de Reims Champagne Ardenne

Reims, 51100, France

Location

MeSH Terms

Interventions

Data Collection

Intervention Hierarchy (Ancestors)

Epidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 15, 2023

First Posted

November 22, 2023

Study Start

January 1, 2024

Primary Completion

May 1, 2024

Study Completion

October 1, 2024

Last Updated

November 22, 2023

Record last verified: 2023-11

Locations