NCT04846608

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 26, 2021

Completed
19 days until next milestone

Study Start

First participant enrolled

April 14, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 15, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
Last Updated

November 18, 2021

Status Verified

November 1, 2021

Enrollment Period

3 months

First QC Date

March 26, 2021

Last Update Submit

November 17, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

    through study completion, an average of 6 months

Secondary Outcomes (8)

  • Age of the patients

    through study completion, an average of 6 months

  • Gender of the patients

    through study completion, an average of 6 months

  • Presence of previous medical cognitive disorder

    through study completion, an average of 6 months

  • Name of nursing home of origin

    through study completion, an average of 6 months

  • Length of stay at emergency room

    through study completion, an average of 6 months

  • +3 more secondary outcomes

Study Arms (2)

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

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

Other: Observation

Interventions

Observation

Nursing home residents with behavioural problemsNursing home residents with other problems

Eligibility Criteria

Age75 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
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

You may qualify if:

  • 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
  • Agitation
  • Dementia
  • Disorientation
  • Delirium

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU de NANCY

Nancy, 54000, France

Location

MeSH Terms

Conditions

Mental Disorders

Interventions

Observation

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

March 26, 2021

First Posted

April 15, 2021

Study Start

April 14, 2021

Primary Completion

June 30, 2021

Study Completion

June 30, 2021

Last Updated

November 18, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations