Health Services for the AgedURG-GERIANCT04970784
Impact of a Dedicated Geriatric Sector on the Loss of Functional Autonomy at 1 Month for Patients Admitted to Emergencies and Non-hospitalised
An observational study of Health Services for the Aged and Emergency Service, Hospital, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Several studies have shown that going to the emergency room is a risk factor for loss of independence in the elderly. It has been shown that the period following an emergency room visit without hospitalization is a period of vulnerability for the elderly. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Health Services for the Aged, Emergency Service, Hospital, Ambulatory Care
- What is being tested?
- Activities of Daily Living (ADL) questionnaire (The Katz index )
- How many people
- 285 participants
- Where
- 1 siteFrance
- Study dates
- 15 Jun 2020to 21 Oct 2020
- 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: Elderly patients admitted to emergencies without hospitalization
Who may be able to join
- Age greater than or equal to 75 years
- Emergency room consultation between 7:30 a.m. and 5:30 p.m.
- Relevant to the adult emergency department
- Return home after consultation
Who cannot join
- Age less than 75 years
- Arrival time between 5.30 p.m. and 7.30 a.m.
- Need to take care of unhooking
- Belonging to the short sector, versatile sector
- Patients hospitalized after consultation
Trial locations and contacts
1 site in 1 country.
France1 site
Centre Hospitalier Alpes Léman, service des urgences
Contamine-sur-Arve
About this study
Several studies have shown that going to the emergency room is a risk factor for loss of independence in the elderly. It has been shown that the period following an emergency room visit without hospitalization is a period of vulnerability for the elderly.
The functional decline, or loss of functional autonomy, of the elderly is associated with an increase in institutionalization, mortality and costs to society.
Read more
Studies have highlighted the risk factors for functional decline in the elderly, such as pre-existing functional and cognitive decline, undernutrition, but no model of care has yet prevented the risk of loss of autonomy after a stay in the emergency room.
A full and early geriatric assessment could prevent functional decline after the emergency room visit.
The primary objective of the study is to assess the impact of a dedicated geriatric sector on the functional decline at 1 month of patients admitted to emergencies without hospitalization by comparing an intervention group (patient having benefited from the geriatric sector) and a group witness ("classic" emergency patient).
The secondary objective is to evaluate the impact of this sector on the number of falls at home as well as the readmission rate within 1 month of going to the emergency room.
- Being tested
- Activities of Daily Living (ADL) questionnaire (The Katz index )
- Keywords
- Elderly, Geriatric sector, Autonomy
- Medical subject headings
- Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Activities of Daily Living (ADL) questionnaire (The Katz index )Other
For patients cared for by the geriatric sector, questionnaire will be filled in at admission D0 and by phone at D30, for the "classic" emergency patients questionnaire will be submitted by phone the day following the consultation D1, and D30.
| Study group | Role | What they receive |
|---|---|---|
| Patients cared for by the adult sector | Patients admitted to emergencies, non-hospitalized and cared for by the adult sector of emergencies (classical emergencies) Receives: Other: Activities of Daily Living (ADL) questionnaire (The Katz index ) | |
| Patients cared for by the geriatric sector | Patients admitted to emergencies, non-hospitalized and cared for by the geriatric sector of emergencies Receives: Other: Activities of Daily Living (ADL) questionnaire (The Katz index ) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of functional decline at 1 month, measured by the Katz index, Activities of Daily Living (ADL)
The Katz index, Activities of Daily Living (ADL) questionnaire, assess through 6 items (ranging from 0 to 1) the aptitude to execute daily life activities.
Measured: At Baseline (admission to ermergencies) and 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2021
- Study start15 Jun 2020
- Primary completion21 Oct 2020
- Study completion21 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health Services for the AgedStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Prospective
- Enrolment
- 285 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jessica POINTURIER, Principal investigator, Centre Hospitalier Alpes Léman, service des urgences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04970784
- Sponsor's protocol ID
- 69HCL19_0973
- Other IDs
- 2020-A00211-38
- Acronym
- URG-GERIA
- Status last verified
- Jul 2021
- First submitted
- 12 Jul 2021
- Last updated
- 21 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Dedicated Geriatric Sector on the Loss of Functional Autonomy at 1 Month for Patients Admitted to Emergencies and Non-hospitalised
- ClinicalTrials.gov ID
- NCT04970784
- Acronym / sponsor ID
- URG-GERIA / 69HCL19_0973
- Keywords
- Elderly, Geriatric sector, Autonomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 285 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 15 Jun 2020 (actual)
- Primary completion
- 21 Oct 2020 (actual)
- Study completion
- 21 Oct 2020 (actual)
- First posted
- 21 Jul 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.
Several studies have shown that going to the emergency room is a risk factor for loss of independence in the elderly. It has been shown that the period following an emergency room visit without hospitalization is a period of vulnerability for the elderly.
The functional decline, or loss of functional autonomy, of the elderly is associated with an increase in institutionalization, mortality and costs to society.
Studies have highlighted the risk factors for functional decline in the elderly, such as pre-existing functional and cognitive decline, undernutrition, but no model of care has yet prevented the risk of loss of autonomy after a stay in the emergency room.
A full and early geriatric assessment could prevent functional decline after the emergency room visit.
The primary objective of the study is to assess the impact of a dedicated geriatric sector on the functional decline at 1 month of patients admitted to emergencies without hospitalization by comparing an intervention group (patient having benefited from the geriatric sector) and a group witness ("classic" emergency patient).
The secondary objective is to evaluate the impact of this sector on the number of falls at home as well as the readmission rate within 1 month of going to the emergency room.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients cared for by the adult sector | – | Other: Activities of Daily Living (ADL) questionnaire (The Katz index )Patients admitted to emergencies, non-hospitalized and cared for by the adult sector of emergencies (classical emergencies) |
| Patients cared for by the geriatric sector | – | Other: Activities of Daily Living (ADL) questionnaire (The Katz index )Patients admitted to emergencies, non-hospitalized and cared for by the geriatric sector of emergencies |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Elderly patients admitted to emergencies without hospitalization
Key inclusion criteria (4 listed)
- Age greater than or equal to 75 years
- Emergency room consultation between 7:30 a.m. and 5:30 p.m.
- Relevant to the adult emergency department
- Return home after consultation
Key exclusion criteria (5 listed)
- Age less than 75 years
- Arrival time between 5.30 p.m. and 7.30 a.m.
- Need to take care of unhooking
- Belonging to the short sector, versatile sector
- Patients hospitalized after consultation
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 |
|---|---|---|
| Activities of Daily Living (ADL) questionnaire (The Katz index )For patients cared for by the geriatric sector, questionnaire will be filled in at admission D0 and by phone at D30, for the "classic" emergency patients questionnaire will be submitted by phone the day following the consultation D1, and D30. | Other | Patients cared for by the adult sector, Patients cared for by the geriatric sector |
Primary outcome
Change of functional decline at 1 month, measured by the Katz index, Activities of Daily Living (ADL)
Time frame: At Baseline (admission to ermergencies) and 1 month
The Katz index, Activities of Daily Living (ADL) questionnaire, assess through 6 items (ranging from 0 to 1) the aptitude to execute daily life activities.
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 21 Jul 2021.
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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.
Jessica POINTURIER principal investigator
Centre Hospitalier Alpes Léman, service des urgences
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 Health Services for the Aged and Emergency Service, Hospital, run by Hospices Civils de Lyon 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 5 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 21 Jul 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?
Change of functional decline at 1 month, measured by the Katz index, Activities of Daily Living (ADL) (time frame: At Baseline (admission to ermergencies) and 1 month). 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 21 Jul 2021.