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

Sponsor
Université de Reims Champagne-Ardenne (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06142864
Collaborator
(none)
120
2
9
60
6.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
120 participants
Observational Model:
Case-Control
Time Perspective:
Cross-Sectional
Official Title:
Prevalence of Falls and Associated Factors in Haemodialysis Patients
Anticipated Study Start Date :
Jan 1, 2024
Anticipated Primary Completion Date :
May 1, 2024
Anticipated Study Completion Date :
Oct 1, 2024

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. mechanical fall. [Day 0]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ufr Medecine Urca Reims France 51100
2 Université de Reims Champagne Ardenne Reims France 51100

Sponsors and Collaborators

  • Université de Reims Champagne-Ardenne

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Université de Reims Champagne-Ardenne
ClinicalTrials.gov Identifier:
NCT06142864
Other Study ID Numbers:
  • 2023_RIPH_019_Chute-Hemo
First Posted:
Nov 22, 2023
Last Update Posted:
Nov 22, 2023
Last Verified:
Nov 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Université de Reims Champagne-Ardenne

Study Results

No Results Posted as of Nov 22, 2023