- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04393649
First Level Socio-geriatric Evaluation: ESOGER Databank
February 22, 2024 updated by: Olivier Beauchet, Jewish General Hospital
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
20000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Quebec
-
Montréal, Quebec, Canada, H3T 1E2
- Jewish General Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
70 years and older (Older Adult)
Accepts Healthy Volunteers
N/A
Sampling Method
Non-Probability Sample
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.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Older patients / community dwellers
The inclusion criteria are:
The exclusion criteria are:
|
Questionnaire
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
COVID-19 symptoms
Time Frame: 1 day
|
presence or not of fever, cough and shortness of breath (binary question)
|
1 day
|
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)
|
1 day
|
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)
|
1 day
|
psychological frailty
Time Frame: 1 day
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anxiety Verbal analogic scale, score from 0 = no anxiety to 10 = extremely anxious)
|
1 day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Caregiver burden
Time Frame: 1 day
|
Zarit scale, score from 0 = no caregiver burden to 16 = high caregiver burden)
|
1 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 20, 2020
Primary Completion (Estimated)
April 19, 2027
Study Completion (Estimated)
April 19, 2027
Study Registration Dates
First Submitted
May 13, 2020
First Submitted That Met QC Criteria
May 13, 2020
First Posted (Actual)
May 19, 2020
Study Record Updates
Last Update Posted (Actual)
February 23, 2024
Last Update Submitted That Met QC Criteria
February 22, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MP-05-2021-2308
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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