Prevalence of Falls and Associated Factors in Haemodialysis Patients (Chute-Hemo)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Haemodialysis Patients
• Intervention / Treatment: Other: Data collection

Detailed Description

The main objective is to describe the prevalence of falls in chronic hemodialysis patients of all ages.

The secondary objective is to study factors associated with the occurrence of falls in chronic hemodialysis patients of all ages

• Study Type: Observational
• Enrollment (Estimated): 120

Contacts and Locations

Study Locations

• France
  • Reims, France, 51100
    • Ufr Medecine Urca
  • Reims, France, 51100
    • Université de Reims Champagne Ardenne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

haemodialysis patients

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
-"Case" patients; -"Case" patients will be patients reporting at least one fall in the last 6 months.	Other: Data collection; Data collection
-"Control" patients; -"Control" patients will be patients reporting no fall in the last 6 months.	Other: Data collection; Data collection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Université de Reims Champagne-Ardenne

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2024
• Primary Completion (Estimated): May 1, 2024
• Study Completion (Estimated): October 1, 2024

Study Registration Dates

• First Submitted: November 15, 2023
• First Submitted That Met QC Criteria: November 15, 2023
• First Posted (Actual): November 22, 2023

Study Record Updates

• Last Update Posted (Actual): November 22, 2023
• Last Update Submitted That Met QC Criteria: November 15, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: falls; haemodialysis; haemodialysis patients
• Other Study ID Numbers: 2023_RIPH_019_Chute-Hemo

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No