AgingROB-UNCT04683380
Robustness Predictive Factors in People Aged Over 75 Years After Going to the Emergency Room (ROB-U)
An observational study of Aging and Emergency Room, run by Lille Catholic University at 1 site in France.
Trial summary
After emergency room visits, the elderly patients can increase their dependence and functional decline. In this context the goal of this study is to demonstrate that there are robustness predictive factors after visit to the emergency room. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Aging, Emergency Room, Risk Factors
- How many people
- 110 participants
- Where
- 1 siteFrance
- Study dates
- 10 Mar 2021to 10 Dec 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: The study population is composed of patients aged more than 75 years old and who have eligibility criteria.
Who may be able to join
- Patients admitted to the emergency room
- Patients aged ≥ 75 years old
- Patients without cognitive disorders or vigilance disorders
- Patients living at home
- Patients able to give its non-opposition
- Non inclusion Criteria:
- Patients admitted to the hospital in the last 3 months
- Patients refusing to participate in the study
Who cannot join
- Patients whose stay is < 14h or > 48h
- Patients who die during hospitalization
- Patient not hospitalized
- Patient not returning home after discharge from hospital
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of the Robustness Predictive Factors in People Aged Over 75 Years After Going to the Emergency Room
After emergency room visits, the elderly patients can increase their dependence and functional decline. In this context the goal of this study is to demonstrate that there are robustness predictive factors after visit to the emergency room.
Read the detailed description
The emergency department is one of the main access routes to the hospital for elderly patients.
Older age is often associated with an increase risk of longer stay in the emergency room with a high subsequent risk of hospital re-admission. One of the essential care objectives when treating these patients is to maintain the autonomy to avoid any dependence in order to keep the quality of life, and limit the time of hospitalization.
Emergency room visits and hospitalizations are too often considered as a source of autonomy loss aggravation in the elderly. Many studies have demonstrated the mortality predictive factors existence, functional decline, or re-hospitalization of the elderly after an emergency room visit or after hospitalization.
No study until now has investigated the existence of factors directly predictive of robustness. Then the goal of this study is to demonstrate that there are robustness predictive factors after going to the emergency room.
- Conditions
- Aging, Emergency Room, Risk Factors
- Keywords
- Elderly dependence, Emergency room visits, Lack of autonomy, Robustness, Re-hospitalization
- Medical subject headings
- Emergencies
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of predictive factors of robustness : Autonomy level at home (ADL score)
ADL self-performance coding ranges from 0 (independent) to 4 (total dependence).
Measured: 3 months
Identification of predictive factors of robustness by a questionnaire (help at home)
Need of help at home such as : toilet, breakfast, lunch, dinner (yes or not)
Measured: 3 months
Identification of predictive factors of robustness by a questionnaire (family visits)
Number of family visits
Measured: 3 months
Identification of predictive factors of robustness by a questionnaire (appetit)
loss of appetite (yes or not)
Measured: 3 months
Identification of predictive factors of robustness (heart rate)
Heart rate during hospitalization (minimum and maximum values)
Measured: 3 months
Identification of predictive factors of robustness (Modified Triage Risk Screening Tool (TRST)) score
The TRST score is a tool to predict repeat emergency department visits and hospitalizations in older patients discharged from the emergency department; This tool evaluates 5 dimensions : cognitive disorders presence, walking disorders, polymedication, hospitalization antecedents and functional assessment (loss of autonomy). Every dimension is worth 1 point if the patient presents the disorder. The final maximum score is 5 points.
Measured: 3 months
Identification of predictive factors of robustness : BMI (Body Mass Index)
Body mass index
Measured: 3 months
Albuminemia
Rate of Albuminemia
Measured: 3 months
Identification of predictive factors of robustness : Lifestyle
Lifestyle: person living alone (yes or not)
Measured: 3 months
Sleep assessment using a Visual Analog Scale (VAS).
This scale allows patients to assess their fatigue. The patients locate their fatigue intensity on a 100-millimeters horizontal line. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity.
Measured: 3 months
Secondary outcomes (3)
Rate of re-hospitalization
Only direct re-hospitalizations in emergency rooms and geriatric short stay will be counted
Measured: 3 months
Rate of patient survival
Rate of patient survival
Measured: 3 months
Rate of lack of Institutionalization
Rate of lack of Institutionalization
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2020
- Study start10 Mar 2021
- Primary completion10 Dec 2021
- Study completion10 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lille Catholic University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean Bouquillon, Principal investigator, Hôpital Saint-Vincent de Paul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04683380
- Sponsor's protocol ID
- RC-P0099
- Acronym
- ROB-U
- Status last verified
- Jan 2022
- First submitted
- 16 Dec 2020
- Last updated
- 6 Jan 2022
- 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 6 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Robustness Predictive Factors in People Aged Over 75 Years After Going to the Emergency Room
- ClinicalTrials.gov ID
- NCT04683380
- Acronym / sponsor ID
- ROB-U / RC-P0099
- Conditions
- Aging, Emergency Room, Risk Factors
- Keywords
- Elderly dependence, Emergency room visits, Lack of autonomy, Robustness, Re-hospitalization
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Lille Catholic UniversityUniversity, hospital or other
- Study start
- 10 Mar 2021 (actual)
- Primary completion
- 10 Dec 2021 (actual)
- Study completion
- 10 Dec 2021 (actual)
- First posted
- 24 Dec 2020 (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.
After emergency room visits, the elderly patients can increase their dependence and functional decline. In this context the goal of this study is to demonstrate that there are robustness predictive factors after visit to the emergency room.
Detailed description
The emergency department is one of the main access routes to the hospital for elderly patients.
Older age is often associated with an increase risk of longer stay in the emergency room with a high subsequent risk of hospital re-admission. One of the essential care objectives when treating these patients is to maintain the autonomy to avoid any dependence in order to keep the quality of life, and limit the time of hospitalization.
Emergency room visits and hospitalizations are too often considered as a source of autonomy loss aggravation in the elderly. Many studies have demonstrated the mortality predictive factors existence, functional decline, or re-hospitalization of the elderly after an emergency room visit or after hospitalization.
No study until now has investigated the existence of factors directly predictive of robustness. Then the goal of this study is to demonstrate that there are robustness predictive factors after going to the emergency room.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- The study population is composed of patients aged more than 75 years old and who have eligibility criteria.
Key inclusion criteria (8 listed)
- Patients admitted to the emergency room
- Patients aged ≥ 75 years old
- Patients without cognitive disorders or vigilance disorders
- Patients living at home
- Patients able to give its non-opposition
Key exclusion criteria (4 listed)
- Patients whose stay is < 14h or > 48h
- Patients who die during hospitalization
- Patient not hospitalized
- Patient not returning home after discharge from hospital
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
Identification of predictive factors of robustness : Autonomy level at home (ADL score)
Time frame: 3 months
ADL self-performance coding ranges from 0 (independent) to 4 (total dependence).
Identification of predictive factors of robustness by a questionnaire (help at home)
Time frame: 3 months
Need of help at home such as : toilet, breakfast, lunch, dinner (yes or not)
Identification of predictive factors of robustness by a questionnaire (family visits)
Time frame: 3 months
Number of family visits
Identification of predictive factors of robustness by a questionnaire (appetit)
Time frame: 3 months
loss of appetite (yes or not)
Identification of predictive factors of robustness (heart rate)
Time frame: 3 months
Heart rate during hospitalization (minimum and maximum values)
Identification of predictive factors of robustness (Modified Triage Risk Screening Tool (TRST)) score
Time frame: 3 months
The TRST score is a tool to predict repeat emergency department visits and hospitalizations in older patients discharged from the emergency department; This tool evaluates 5 dimensions : cognitive disorders presence, walking disorders, polymedication, hospitalization antecedents and functional assessment (loss of autonomy). Every dimension is worth 1 point if the patient presents the disorder. The final maximum score is 5 points.
Identification of predictive factors of robustness : BMI (Body Mass Index)
Time frame: 3 months
Body mass index
Albuminemia
Time frame: 3 months
Rate of Albuminemia
Identification of predictive factors of robustness : Lifestyle
Time frame: 3 months
Lifestyle: person living alone (yes or not)
Sleep assessment using a Visual Analog Scale (VAS).
Time frame: 3 months
This scale allows patients to assess their fatigue. The patients locate their fatigue intensity on a 100-millimeters horizontal line. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity.
3 secondary outcomes
Rate of re-hospitalization
Time frame: 3 months
Rate of patient survival
Time frame: 3 months
Rate of lack of Institutionalization
Time frame: 3 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 6 Jan 2022.
- 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.
Jean Bouquillon principal investigator
Hôpital Saint-Vincent de Paul
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 Aging and Emergency Room, run by Lille Catholic University 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 8 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 6 Jan 2022. 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?
Identification of predictive factors of robustness : Autonomy level at home (ADL score) (time frame: 3 months). The study lists 10 primary outcomes in all. 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 6 Jan 2022.