COVIDNCT04393649
First Level Socio-geriatric Evaluation: ESOGER Databank
An observational study of COVID and Social Isolation, run by Jewish General Hospital at 1 site in Canada.
Trial summary
Coronavirus disease 2019 (COVID-19) is an infectious disease. Physical distancing is one of the most effective ways to reduce the spread of COVID-19, but this key prevention intervention may have adverse consequences on older adults living at home. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- COVID, Social Isolation, Anxiety
- What is being tested?
- ESOGER
- How many people
- 20,000 participants
- Where
- 1 siteCanada
- Study dates
- 20 Apr 2020to 19 Apr 2027
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 70 years and older
- All sexes
- Older adult
Study population: All the older patients and community dwellers living at home in Montreal contacted by the researchers and corresponding to the criteria. The project is about a constitution of a databank.
The inclusion criteria are:
- Older (i.e., 70-years-old and over) adults OR caregiver living at home with an adult answering to inclusion criteria
- Living and staying at home because of physical and social distancing
- Understanding and writing the different languages of the recruitment centre (i.e., French, English, Chinese.)
- Agree to participate in the study
The exclusion criteria are:
- A concomitant participation to another medical trial
- Living in semi-autonomous residence or CHSLD
Trial locations and contacts
1 site in 1 country.
About this study
Official title: First Level Socio-geriatric Evaluation in Period of Physical and Social Distancing in Frail Older Patients and Older Community Dwellers: ESOGER Databank
Coronavirus disease 2019 (COVID-19) is an infectious disease. Physical distancing is one of the most effective ways to reduce the spread of COVID-19, but this key prevention intervention may have adverse consequences on older adults living at home. Screening older adults living at home and at risk for adverse consequences of physical and social distancing is, therefore, a priority in order to prevent their occurrence. ESOGER ("Evaluation Social et GERiatrique") is a clinical tool designed to: 1) screen the risk-levels for adverse consequences related to COVID-19 physical distancing and 2) to continue appropriate preventive interventions in older adults living at home including frail older patients and older community dwellers. Experience cumulated during the past two weeks revealed that ESOGER could be improved, in order to be more effective and efficient for the prevention of adverse consequences related to COVID-19 physical distancing. This improvement is based on two key components: 1) Comments of Montreal ESOGER users and 2) Analysis of data. Because at this time no information is saved and stored, there is a need to save and store ESOGER information and create the ESOGER databank.
- Conditions
- COVID, Social Isolation, Anxiety, Frailty
- Being tested
- ESOGER
- Medical subject headings
- Social Isolation, Anxiety Disorders, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ESOGEROther
Questionnaire
| Study group | Role | What they receive |
|---|---|---|
| Older patients / community dwellers | The inclusion criteria are:
1. Older (i.e., 70-years-old and over) adults OR caregiver living at home with an adult answering to inclusion criteria
2. Living and staying at home because of physical and social distancing
3. Understanding and writing the different languages of the recruitment centre (i.e., French, English, Chinese.)
4. Agree to participate in the study
The exclusion criteria are:
1. A concomitant participation to another medical trial
2. Living in semi-autonomous residence or CHSLD Receives: Other: ESOGER |
What is being measured
The primary outcome is the main question the study is designed to answer.
COVID-19 symptoms
presence or not of fever, cough and shortness of breath (binary question)
Measured: 1 day
issues related to medication and food delivery and access to home care
presence or not of a rupture of access to food, medication and home care (binary question)
Measured: 1 day
physical frailty
Questionnaire Emergency Room Evaluation and Recommandation (ER2), score from 0 = no risk of frailty to 14 = high risk of frailty)
Measured: 1 day
psychological frailty
anxiety Verbal analogic scale, score from 0 = no anxiety to 10 = extremely anxious)
Measured: 1 day
Secondary outcomes (1)
Caregiver burden
Zarit scale, score from 0 = no caregiver burden to 16 = high caregiver burden)
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2020
- Study start20 Apr 2020
- Primary completion19 Apr 2027 (estimated)
- Study completion19 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVIDStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20,000 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Jewish General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Olivier Beauchet, Jewish General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04393649
- Sponsor's protocol ID
- MP-05-2021-2308
- Status last verified
- Feb 2024
- First submitted
- 13 May 2020
- Last updated
- 23 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- First Level Socio-geriatric Evaluation in Period of Physical and Social Distancing in Frail Older Patients and Older Community Dwellers: ESOGER Databank
- ClinicalTrials.gov ID
- NCT04393649
- Acronym / sponsor ID
- MP-05-2021-2308
- Conditions
- COVID, Social Isolation, Anxiety, Frailty
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 20,000 participants (actual)
- Lead sponsor
- Jewish General HospitalUniversity, hospital or other
- Study start
- 20 Apr 2020 (actual)
- Primary completion
- 19 Apr 2027 (estimated)
- Study completion
- 19 Apr 2027 (estimated)
- First posted
- 19 May 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.
Coronavirus disease 2019 (COVID-19) is an infectious disease. Physical distancing is one of the most effective ways to reduce the spread of COVID-19, but this key prevention intervention may have adverse consequences on older adults living at home. Screening older adults living at home and at risk for adverse consequences of physical and social distancing is, therefore, a priority in order to prevent their occurrence. ESOGER ("Evaluation Social et GERiatrique") is a clinical tool designed to: 1) screen the risk-levels for adverse consequences related to COVID-19 physical distancing and 2) to continue appropriate preventive interventions in older adults living at home including frail older patients and older community dwellers. Experience cumulated during the past two weeks revealed that ESOGER could be improved, in order to be more effective and efficient for the prevention of adverse consequences related to COVID-19 physical distancing. This improvement is based on two key components: 1) Comments of Montreal ESOGER users and 2) Analysis of data. Because at this time no information is saved and stored, there is a need to save and store ESOGER information and create the ESOGER databank.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Older patients / community dwellers | – | Other: ESOGERThe inclusion criteria are: 1. Older (i.e., 70-years-old and over) adults OR caregiver living at home with an adult answering to inclusion criteria 2. Living and staying at home because of physical and social distancing 3. Understanding and writing the different languages of the recruitment centre (i.e., French, English, Chinese.) 4. Agree to participate in the study The exclusion criteria are: 1. A concomitant participation to another medical trial 2. Living in semi-autonomous residence or CHSLD |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Age groups
- Older adult
- Study population
- All the older patients and community dwellers living at home in Montreal contacted by the researchers and corresponding to the criteria. The project is about a constitution of a databank.
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 |
|---|---|---|
| ESOGERQuestionnaire | Other | Older patients / community dwellers |
Primary outcome
COVID-19 symptoms
Time frame: 1 day
presence or not of fever, cough and shortness of breath (binary question)
issues related to medication and food delivery and access to home care
Time frame: 1 day
presence or not of a rupture of access to food, medication and home care (binary question)
physical frailty
Time frame: 1 day
Questionnaire Emergency Room Evaluation and Recommandation (ER2), score from 0 = no risk of frailty to 14 = high risk of frailty)
psychological frailty
Time frame: 1 day
anxiety Verbal analogic scale, score from 0 = no anxiety to 10 = extremely anxious)
1 secondary outcome
Caregiver burden
Time frame: 1 day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2024.
- Individual participant dataSharing planned: Undecided
Related trials for COVID
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
RecruitingPhase 2
SARS-CoV-2 and Herpesvirus Inhibition for Ending Long COVID Dysfunction
Post-acute Sequelae of COVID-19, Long COVID
Active, not recruitingObservational study
A Study to Learn About COVID-19 Antivirals in People With SARS-CoV-2 Infection From 2023-2026
COVID-19 SARS-CoV-2 Infection
RecruitingPhase 4
Comparative Immunogenicity of Respiratory Virus Vaccines (CIRV2) Study
COVID -19, COVID - 19
Enrolling by invitation
Fareon Open Label Device Clinical Trial
Cognitive Dysfunction, Acquired Brain Injury
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 COVID and Social Isolation, run by Jewish General Hospital at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: under way, not looking for participants, as of the sponsor's last update on 23 Feb 2024. 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 Canada. 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?
This study is still under way. Results are not available in the source record yet.
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?
COVID-19 symptoms (time frame: 1 day). The study lists 4 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 23 Feb 2024.