- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05062590
Evolution and Adaptation to Caregiver of a Socio-geriatric Evaluation (ESOGER)
February 22, 2024 updated by: Olivier Beauchet, Centre integre universitaire de sante et de services sociaux du Centre-Sud-de-l'Île-de-Montréal
Socio-geriatric Evaluation (ESOGER): A Clinical Tool in Telehealth to Fight Against Vulnerable Seniors's Health Alterations and Social Isolation
With the COVID-19 pandemic, elderly people (EP) living at home have seen their health deteriorated, thus increasing their needs in support and care.
Indeed, while it was estimated that before the pandemic120 000 unattended living at home EP required care and services (taking bath, access to medication and food, etc.), the number doubled after COVID-19.
Therefore, the waiting list for socio-medical services for unattended vulnerable clientele without a family doctor grew from 1300 à 1715 EP in a couple of months during the pandemic.
With these numbers, it becomes clear that an intervention is needed.
Truly, the Institut National d'Excellence en Santé et Services Sociaux (INESSS) conclude that it was pivotal to first identify the most vulnerable EP and second re-orient them according to their needs.
Thus the investigator developed the Évaluation et orientation SOcio-GÉRiatrique (ESOGER) questionnaire available on a secure digital plateform enabling both a rapid evaluation and intervention to asses EP needs and provide the adequate ressources.
Investigator's previous research has demonstrated that ESOGER is one of the rare clinical tools of first contact in telehealth while being global, multidimensional, and equitable.
For this study, the investigator aims to evaluate the effect of ESOGER on EP physical and mental health, loss of autonomy, social isolation, quality of life and ressources consumption.
Study Overview
Study Type
Interventional
Enrollment (Estimated)
260
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Olivier Beauchet, MD
- Phone Number: 3637 514-340-3540
- Email: olivier.beauchet@umontreal.ca
Study Locations
-
-
Quebec
-
Montréal, Quebec, Canada, H3W 1W5
- Recruiting
- CRIUGM
-
Contact:
- Kévin Galéry
-
-
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
65 years and older (Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Aged 65 and more
- Living at home on the territory CIUSSS-Centre-Sud de l'île-de-Montréal (CCSMTL) of Jeanne-Mance
- Brief Geriatric Assessment (BGA) score of 1/14 or more defining a severly to milidly frail health.
Exclusion Criteria:
- Principal address outside of the CCSMTL's Jeanne-Mance territory
- Participate at another clinical trial, to avoid interferences
- Not understand written or spoken French or English, questionnaires are only available in French and English.
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
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group Intervention
Experimental: Group 1 The intervention group will take the ESOGER questionnaire at month 0 and month 3 ( beginning and end) and receive recommendations following their needs.
|
Ressources recommendations and interventions curated to the needs of the EP such as refering them to a social activity for socially isolated EP
|
|
No Intervention: Group control
The participants will only take the ESOGER questionnaire at month 0 and month 3 without recommendations
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
psychological fraility
Time Frame: 3 months
|
Anxiety verbal analogic scale, score from 0= no anxiety to 10= extremly anxious
|
3 months
|
|
Socio-economic characteristics
Time Frame: 3 months
|
Presence or not of socio-economic problems (binary questions)
|
3 months
|
|
Participant's Quality of life
Time Frame: 3 months
|
Measured by the EQ-5D scale with two parts, scale 1 score from 1= no problem to 5 ( sever health problems) and scale 2 visual analogic scale score from 0= worst possible health to 100= best possible health.
|
3 months
|
|
Autonomy
Time Frame: 3 months
|
ADL scale score from 0= very dependent to 6= very independent and IADL scale score 0= not autonomous 4= autonomous.
|
3 months
|
|
COVID-19 symptoms
Time Frame: 3 months
|
presence or not of fever, cough, and shortness of breath (binary question)
|
3 months
|
|
Social health
Time Frame: 3 months
|
Issues related to medication and food delivery and access to home care.
Presence or not of a shortage in food, medication and home care ( binary question)
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Caregiver burden
Time Frame: 3 months
|
Based on Zarit scale, score from 0= no burden to 16= high caregiver burnder
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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 4, 2022
Primary Completion (Estimated)
June 1, 2025
Study Completion (Estimated)
March 1, 2026
Study Registration Dates
First Submitted
September 21, 2021
First Submitted That Met QC Criteria
September 29, 2021
First Posted (Actual)
September 30, 2021
Study Record Updates
Last Update Posted (Estimated)
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
Other Study ID Numbers
- 2022-616
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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