First Level Socio-geriatric Evaluation: ESOGER Databank

Anxiety Clinical Trial

Official title:

First Level Socio-geriatric Evaluation in Period of Physical and Social Distancing in Frail Older Patients and Older Community Dwellers: ESOGER Databank

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04393649
• Other study ID #: MP-05-2021-2308
• Status: Active, not recruiting
• Start date: April 20, 2020
• Est. completion date: April 19, 2027

Study information

• Verified date: February 2024
• Source: Jewish General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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. 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20000
• Est. completion date: April 19, 2027
• Est. primary completion date: April 19, 2027
• Gender: All
• Age group: 70 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• COVID
• Frailty
• Social Isolation

Intervention

Other:
• ESOGER
Questionnaire

Locations

Country	Name	City	State
Canada	Jewish General Hospital	Montréal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Jewish General Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	COVID-19 symptoms	presence or not of fever, cough and shortness of breath (binary question)	1 day
Primary	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)	1 day
Primary	physical frailty	Questionnaire Emergency Room Evaluation and Recommandation (ER2), score from 0 = no risk of frailty to 14 = high risk of frailty)	1 day
Primary	psychological frailty	anxiety Verbal analogic scale, score from 0 = no anxiety to 10 = extremely anxious)	1 day
Secondary	Caregiver burden	Zarit scale, score from 0 = no caregiver burden to 16 = high caregiver burden)	1 day