Behavioral DisordersNCT04846608
Descriptive Study of Emergency Room Visits From Nursing Home Residents for Behavioral Problems at the Nancy University Hospital: Place of the Advanced Practice Nurse
An observational study of Behavioral Disorders, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
The demographic evolution of old age is a reality. After the age of 75, 2 out of 3 people living in institutions have neurocognitive disorders. Behavioural disorders such as physical aggression, agitation, hallucinations, sleep disorders, generate difficulties in the management of these patients and lead to… Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Behavioral Disorders
- What is being tested?
- Observation
- How many people
- 4,000 participants
- Where
- 1 siteFrance
- Study dates
- 14 Apr 2021to 30 Jun 2021
- 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 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: All persons aged 75 and over, residents of nursing homes in the Nancy area, who consulted the emergency department during the 6 month study period
Who may be able to join
- Person who has received full information on the organization of the research and has not objected to the use of this data
- Elderly men and women 75 years of age and older at the time of the emergency room visit
- Having for main residence one of the nursing homes of the Grand Nancy
- Administratively present in the emergency department
- Having been admitted to the emergency room for the following reasons:
- Behavioural problems
Show all 10Show fewer
- Agitation
- Dementia
- Disorientation
- Delirium
Who cannot join
- People under 75 years of age
- Residing at home or in a senior residence or in a nursing home outside Grand Nancy
- Referred by an inpatient department (rehabilitation department)
- Other reasons for emergency room use such as "depression" and "apathy
Trial locations and contacts
1 site in 1 country.
About this study
The demographic evolution of old age is a reality. After the age of 75, 2 out of 3 people living in institutions have neurocognitive disorders. Behavioural disorders such as physical aggression, agitation, hallucinations, sleep disorders, generate difficulties in the management of these patients and lead to unscheduled emergency hospitalizations. Non-pharmacological management of behavioral disorders is recommended as a first-line treatment because of its low risk and potential improvement (Haute Autorité de Santé 2009). However, this management is not simple and obvious to put in place, especially since not all elderly people with Behavioural disorders are in adapted structures. The advanced practice nurse specializing in geriatrics has a place in this care pathway. Because of her skills, she could "organize multi-professional care, set up analyses of practices within the nursing homes, train caregivers appropriately, and limit hospitalizations due to behavioral problems" (SALIEGE L. 2020). Advanced practice nursing is in its infancy in France, and everything remains to be done (International Council of Nurses- directive). The aim of the study is to identify the number of emergency room visits by people aged 75 and over for behavioral problems in nursing home during a 6 month-period.
- Conditions
- Behavioral Disorders
- Being tested
- Observation
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationOther
Observation
| Study group | Role | What they receive |
|---|---|---|
| Nursing home residents with behavioural problems | Nursing home residents from Grand Nancy aged 75 and over referred to emergency departments for disorientation, agitation, dementia or behavioural problems during the study period Receives: Other: Observation | |
| Nursing home residents with other problems | Nursing home residents from Grand Nancy aged 75 and over referred to emergency departments for other reasons Receives: Other: Observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of passage of people aged 75 and over referred to emergency departments by nursing homes for disorientation, agitation, dementia or behavioural problems during the study period
Number of passage of people aged 75 and over referred to emergency departments by nursing homes for disorientation, agitation, dementia or behavioural problems during the study period
Measured: through study completion, an average of 6 months
Secondary outcomes (8)
Age of the patients
Measured: through study completion, an average of 6 months
Gender of the patients
Measured: through study completion, an average of 6 months
Presence of previous medical cognitive disorder
Measured: through study completion, an average of 6 months
Name of nursing home of origin
Measured: through study completion, an average of 6 months
Length of stay at emergency room
Measured: through study completion, an average of 6 months
Referral after visit at emergency room
Measured: through study completion, an average of 6 months
Number of iterative passage of people aged 75 and over referred to emergency departments by nursing homes for disorientation, agitation, dementia or behavioural problems during the study period
Measured: through study completion, an average of 6 months
Presence of intervention of geriatric mobile team
Measured: through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2021
- Study start14 Apr 2021
- Primary completion30 Jun 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Behavioral DisordersStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 4,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Collaborators
- Marie MANGEOT- Nurse, Mahmut GUNDESLI MD
- Responsible party
- Principal investigator, Bernadette HANESSE, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04846608
- Sponsor's protocol ID
- 2021PI027
- Status last verified
- Nov 2021
- First submitted
- 26 Mar 2021
- Last updated
- 18 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Descriptive Study of Emergency Room Visits From Nursing Home Residents for Behavioral Problems at the Nancy University Hospital: Place of the Advanced Practice Nurse
- ClinicalTrials.gov ID
- NCT04846608
- Acronym / sponsor ID
- 2021PI027
- Conditions
- Behavioral Disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,000 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Collaborators
- Marie MANGEOT- Nurse, Mahmut GUNDESLI MD
- Study start
- 14 Apr 2021 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 15 Apr 2021 (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.
The demographic evolution of old age is a reality. After the age of 75, 2 out of 3 people living in institutions have neurocognitive disorders. Behavioural disorders such as physical aggression, agitation, hallucinations, sleep disorders, generate difficulties in the management of these patients and lead to unscheduled emergency hospitalizations. Non-pharmacological management of behavioral disorders is recommended as a first-line treatment because of its low risk and potential improvement (Haute Autorité de Santé 2009). However, this management is not simple and obvious to put in place, especially since not all elderly people with Behavioural disorders are in adapted structures. The advanced practice nurse specializing in geriatrics has a place in this care pathway. Because of her skills, she could "organize multi-professional care, set up analyses of practices within the nursing homes, train caregivers appropriately, and limit hospitalizations due to behavioral problems" (SALIEGE L. 2020). Advanced practice nursing is in its infancy in France, and everything remains to be done (International Council of Nurses- directive). The aim of the study is to identify the number of emergency room visits by people aged 75 and over for behavioral problems in nursing home during a 6 month-period.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nursing home residents with behavioural problems | – | Other: ObservationNursing home residents from Grand Nancy aged 75 and over referred to emergency departments for disorientation, agitation, dementia or behavioural problems during the study period |
| Nursing home residents with other problems | – | Other: ObservationNursing home residents from Grand Nancy aged 75 and over referred to emergency departments for other reasons |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- All persons aged 75 and over, residents of nursing homes in the Nancy area, who consulted the emergency department during the 6 month study period
Key inclusion criteria (10 listed)
- Person who has received full information on the organization of the research and has not objected to the use of this data
- Elderly men and women 75 years of age and older at the time of the emergency room visit
- Having for main residence one of the nursing homes of the Grand Nancy
- Administratively present in the emergency department
- Having been admitted to the emergency room for the following reasons:
Key exclusion criteria (4 listed)
- People under 75 years of age
- Residing at home or in a senior residence or in a nursing home outside Grand Nancy
- Referred by an inpatient department (rehabilitation department)
- Other reasons for emergency room use such as "depression" and "apathy
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 |
|---|---|---|
| ObservationObservation | Other | Nursing home residents with behavioural problems, Nursing home residents with other problems |
Primary outcome
Number of passage of people aged 75 and over referred to emergency departments by nursing homes for disorientation, agitation, dementia or behavioural problems during the study period
Time frame: through study completion, an average of 6 months
Number of passage of people aged 75 and over referred to emergency departments by nursing homes for disorientation, agitation, dementia or behavioural problems during the study period
8 secondary outcomes
Age of the patients
Time frame: through study completion, an average of 6 months
Gender of the patients
Time frame: through study completion, an average of 6 months
Presence of previous medical cognitive disorder
Time frame: through study completion, an average of 6 months
Name of nursing home of origin
Time frame: through study completion, an average of 6 months
Length of stay at emergency room
Time frame: through study completion, an average of 6 months
Referral after visit at emergency room
Time frame: through study completion, an average of 6 months
Number of iterative passage of people aged 75 and over referred to emergency departments by nursing homes for disorientation, agitation, dementia or behavioural problems during the study period
Time frame: through study completion, an average of 6 months
Presence of intervention of geriatric mobile team
Time frame: through study completion, an average of 6 months
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 18 Nov 2021.
- Individual participant dataSharing planned: No
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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.
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 Behavioral Disorders, run by Central Hospital, Nancy, France 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 10 inclusion and 4 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 18 Nov 2021. 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?
Number of passage of people aged 75 and over referred to emergency departments by nursing homes for disorientation, agitation, dementia or behavioural problems during the study period (time frame: through study completion, an average of 6 months). 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 18 Nov 2021.