to Elaborate a New Simple Clinical Tool for the Risk of Falls Among Older Inpatients.EPRICNCT02120209
Prediction of Falls in Older Inpatients Hospitalized at Angers University Hospital
An observational study of to Elaborate a New Simple Clinical Tool for the Risk of Falls Among Older Inpatients., run by University Hospital, Angers at 1 site in France.
Trial summary
The primary objective of this study is to elaborate a new simple clinical tool for the risk of falls among older inpatients. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- to Elaborate a New Simple Clinical Tool for the Risk of Falls Among Older Inpatients.
- How many people
- 1,300 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2013to Nov 2013
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: All patients hospitalized in acute care units participating in study in Angers University Hospital with respect to the eligibility criteria
Who may be able to join
- Age ≥ 65 years
- participants who did not issue opposition to participation in the study
- Patients hospitalized at the University Hospital of Angers in acute care units participating in study
- Being affiliated to a social security regime
Who cannot join
- Opposition to the use of information collected for research purposes.
- Age < 65 years
Trial locations and contacts
1 site in 1 country.
France1 site
University Memory Center, Angers University Hospital
Angers, Pays de la Loire Region, 49933
About this study
Official title: Nurse Screening Tool for Fall Risk : Prediction of Falls in Older Inpatients Hospitalized at Angers University Hospital
The primary objective of this study is to elaborate a new simple clinical tool for the risk of falls among older inpatients.
Read the detailed description
Falling is a common event within hospitals, with a rate calculated between 2.9-13 per 1,000 bed-days . Falls lead to prolonged length of hospital stays (LHS). The first step of an efficient and cost-effectiveness strategy of fall prevention is the screening of individuals at higher risk of falls. Recently, a brief geriatric assessment (BGA) composed of a few number of items has demonstrated to successfully predict the risk of prolonged LHS (5). We hypothesized that the use of the BGA items would make it possible to predict the occurrence of falls among older inpatients.
- Keywords
- assessment; falls; older adults; prediction scale; standardized declaration
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical characteristics (i.e., Brief geriatric assessment items)
Measured: recorded at baseline when older adult were admited to acute care units.
Secondary outcomes (3)
Occurrence of falls
Measured: assessed between 2 and 21 hospitalization days
Number of falls
Measured: assessed between 2 and 21 hospitalization days
Severity of falls
Measured: assessed between 2 and 21 hospitalization days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2014 (estimated)
- Study startApr 2013
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for to Elaborate a New Simple Clinical Tool for the Risk of Falls Among Older Inpatients.Studies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,300 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02120209
- Sponsor's protocol ID
- 2013/24
- Acronym
- EPRIC
- Status last verified
- Apr 2014
- First submitted
- 17 Apr 2014
- Last updated
- 22 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nurse Screening Tool for Fall Risk : Prediction of Falls in Older Inpatients Hospitalized at Angers University Hospital
- ClinicalTrials.gov ID
- NCT02120209
- Acronym / sponsor ID
- EPRIC / 2013/24
- Keywords
- assessment; falls; older adults; prediction scale; standardized declaration
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,300 participants (actual)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- Apr 2013
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 22 Apr 2014 (estimated)
- 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.
The primary objective of this study is to elaborate a new simple clinical tool for the risk of falls among older inpatients.
Detailed description
Falling is a common event within hospitals, with a rate calculated between 2.9-13 per 1,000 bed-days . Falls lead to prolonged length of hospital stays (LHS). The first step of an efficient and cost-effectiveness strategy of fall prevention is the screening of individuals at higher risk of falls. Recently, a brief geriatric assessment (BGA) composed of a few number of items has demonstrated to successfully predict the risk of prolonged LHS (5). We hypothesized that the use of the BGA items would make it possible to predict the occurrence of falls among older inpatients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- All patients hospitalized in acute care units participating in study in Angers University Hospital with respect to the eligibility criteria
Key inclusion criteria (4 listed)
- Age ≥ 65 years
- participants who did not issue opposition to participation in the study
- Patients hospitalized at the University Hospital of Angers in acute care units participating in study
- Being affiliated to a social security regime
Key exclusion criteria (2 listed)
- Opposition to the use of information collected for research purposes.
- Age < 65 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Clinical characteristics (i.e., Brief geriatric assessment items)
Time frame: recorded at baseline when older adult were admited to acute care units.
3 secondary outcomes
Occurrence of falls
Time frame: assessed between 2 and 21 hospitalization days
Number of falls
Time frame: assessed between 2 and 21 hospitalization days
Severity of falls
Time frame: assessed between 2 and 21 hospitalization days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2014.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of to Elaborate a New Simple Clinical Tool for the Risk of Falls Among Older Inpatients., run by University Hospital, Angers at 1 site 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 4 inclusion and 2 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: finished, as of the sponsor's last update on 22 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Clinical characteristics (i.e., Brief geriatric assessment items) (time frame: recorded at baseline when older adult were admited to acute care units.). 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 Apr 2014.