NCT04393649

Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20,000

participants targeted

Target at P75+ for all trials

Timeline
11mo left

Started Apr 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress87%
Apr 2020Apr 2027

Study Start

First participant enrolled

April 20, 2020

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

May 13, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 19, 2020

Completed
6.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 19, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 19, 2027

Last Updated

February 23, 2024

Status Verified

February 1, 2024

Enrollment Period

7 years

First QC Date

May 13, 2020

Last Update Submit

February 22, 2024

Conditions

Outcome Measures

Primary Outcomes (4)

  • COVID-19 symptoms

    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

    presence or not of a rupture of access to food, medication and home care (binary question)

    1 day

  • physical frailty

    Questionnaire Emergency Room Evaluation and Recommandation (ER2), score from 0 = no risk of frailty to 14 = high risk of frailty)

    1 day

  • psychological frailty

    anxiety Verbal analogic scale, score from 0 = no anxiety to 10 = extremely anxious)

    1 day

Secondary Outcomes (1)

  • Caregiver burden

    1 day

Study Arms (1)

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

Other: ESOGER

Interventions

ESOGEROTHER

Questionnaire

Older patients / community dwellers

Eligibility Criteria

Age70 Years+
Sexall
Age GroupsOlder Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • A concomitant participation to another medical trial
  • Living in semi-autonomous residence or CHSLD

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

Location

MeSH Terms

Conditions

Social IsolationAnxiety DisordersFrailty

Condition Hierarchy (Ancestors)

Social BehaviorBehaviorMental DisordersPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior clinician researcher

Study Record Dates

First Submitted

May 13, 2020

First Posted

May 19, 2020

Study Start

April 20, 2020

Primary Completion (Estimated)

April 19, 2027

Study Completion (Estimated)

April 19, 2027

Last Updated

February 23, 2024

Record last verified: 2024-02

Locations