NCT05062590

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
260

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
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

First Submitted

Initial submission to the registry

September 21, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 30, 2021

Completed
6 months until next milestone

Study Start

First participant enrolled

April 4, 2022

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

February 23, 2024

Status Verified

February 1, 2024

Enrollment Period

3.2 years

First QC Date

September 21, 2021

Last Update Submit

February 22, 2024

Conditions

Outcome Measures

Primary Outcomes (6)

  • COVID-19 symptoms

    presence or not of fever, cough, and shortness of breath (binary question)

    3 months

  • psychological fraility

    Anxiety verbal analogic scale, score from 0= no anxiety to 10= extremly anxious

    3 months

  • Social health

    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

  • Socio-economic characteristics

    Presence or not of socio-economic problems (binary questions)

    3 months

  • Participant's Quality of life

    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

    ADL scale score from 0= very dependent to 6= very independent and IADL scale score 0= not autonomous 4= autonomous.

    3 months

Secondary Outcomes (1)

  • Caregiver burden

    3 months

Study Arms (2)

Group Intervention

EXPERIMENTAL

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.

Other: Recommendations

Group control

NO INTERVENTION

The participants will only take the ESOGER questionnaire at month 0 and month 3 without recommendations

Interventions

Ressources recommendations and interventions curated to the needs of the EP such as refering them to a social activity for socially isolated EP

Group Intervention

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CRIUGM

Montreal, Quebec, H3W 1W5, Canada

RECRUITING

MeSH Terms

Conditions

Social Isolation

Interventions

Health Planning Guidelines

Condition Hierarchy (Ancestors)

Social BehaviorBehavior

Intervention Hierarchy (Ancestors)

Health PlanningHealth Care Economics and Organizations

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD, Senior researcher, Director of laboratory

Study Record Dates

First Submitted

September 21, 2021

First Posted

September 30, 2021

Study Start

April 4, 2022

Primary Completion

June 1, 2025

Study Completion

March 1, 2026

Last Updated

February 23, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations