Haemodialysis PatientsChute-HemoNCT06142864
Prevalence of Falls and Associated Factors in Haemodialysis Patients
An observational study of Haemodialysis Patients, run by Université de Reims Champagne-Ardenne at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Haemodialysis Patients
- What is being tested?
- Data collection
- How many people
- 120 participants
- Where
- 2 sitesFrance
- Study dates
- 1 Jan 2024to 1 Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: haemodialysis patients
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
France2 sites
Ufr Medecine Urca
Reims, 51100
Université de Reims Champagne Ardenne
Reims, 51100
About this study
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.
Read more
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.
Read the 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
- Conditions
- Haemodialysis Patients
- Being tested
- Data collection
- Keywords
- haemodialysis, falls, haemodialysis patients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data collectionOther
Data collection
| Study group | Role | What they receive |
|---|---|---|
| -"Case" patients | -"Case" patients will be patients reporting at least one fall in the last 6 months. Receives: Other: Data collection | |
| -"Control" patients | -"Control" patients will be patients reporting no fall in the last 6 months. Receives: Other: Data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2023
- Study start1 Jan 2024 (estimated)
- Primary completion1 May 2024 (estimated)
- Study completion1 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Haemodialysis PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université de Reims Champagne-Ardenne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06142864
- Sponsor's protocol ID
- 2023_RIPH_019_Chute-Hemo
- Acronym
- Chute-Hemo
- Status last verified
- Nov 2023
- First submitted
- 15 Nov 2023
- Last updated
- 22 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Falls and Associated Factors in Haemodialysis Patients
- ClinicalTrials.gov ID
- NCT06142864
- Acronym / sponsor ID
- Chute-Hemo / 2023_RIPH_019_Chute-Hemo
- Conditions
- Haemodialysis Patients
- Keywords
- haemodialysis, falls, haemodialysis patients
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Université de Reims Champagne-ArdenneUniversity, hospital or other
- Study start
- 1 Jan 2024 (estimated)
- Primary completion
- 1 May 2024 (estimated)
- Study completion
- 1 Oct 2024 (estimated)
- First posted
- 22 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| -"Case" patients | – | Other: Data collection-"Case" patients will be patients reporting at least one fall in the last 6 months. |
| -"Control" patients | – | Other: Data collection-"Control" patients will be patients reporting no fall in the last 6 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- haemodialysis patients
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Data collectionData collection | Other | -"Case" patients, -"Control" patients |
Primary outcome
mechanical fall.
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Haemodialysis Patients, run by Université de Reims Champagne-Ardenne at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mechanical fall. (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2023.