E-health and People Living With Major Neurocognitive Disorder - CARE© and ESOGER© Applications (TNCM)

E-health and People Living With Major Neurocognitive Disorder: A Study of the Effects of the CARE© and ESOGER© Applications

The care pathways of people living with major neurocognitive disorders (MNCD) are often inadequate due to poor access to resources, long delays, and resources that are poorly adapted to expectations and needs. This situation was exacerbated during the coronavirus disease (COVID-19) pandemic due to the reduction of available resources and care provider burnout. People living with MNCD are at risk of becoming more fragile, which can lead to emergency room visits and hospitalizations, and significantly alter the quality of life of the dyad (family caregiver and the person being cared for). Intervening earlier in the care pathway would make it possible to avoid the aggravation of pathologies associated with MNCD and hospitalizations.

The reorganization of activities imposed by the social distancing measures due to the pandemic has shown that e-health is a solution to maintain access to resources for people living with chronic conditions such as MNCD. We have been working since the beginning of the pandemic on the development of two complementary health applications for seniors and their dyads: the self-assessment questionnaire on frailty (CARE©) and the Evaluation et orientation SOcio-GÉRiatrique (ESOGER©) questionnaire :

• CARE© is made by the dyad, allowing to identify a state of frailty and the risks related to it. It relies on the active participation of the user and is deployed in the form of an application.
• ESOGER© is a standardized hetero-questionnaire filled out remotely, during a telephone call, by a community organization worker with the user and/or his/her caregiver. It is a tool for first contact, listening and accompanying a user, which makes it possible to determine whether the needs for care and services are being met, to prioritize the needs, to trigger the implementation of care and services, and to make the link with the organizations providing care and services.

The objectives of this study are to examine the effects of CARE© combined with ESOGER© on the state of physical and mental frailty, loss of autonomy, quality of life, and consumption of health services and care resources in people living with a major neurocognitive disorder (MNCD).

Study Overview

• Status: Completed
• Conditions: Frailty; Major Neurocognitive Disorder
• Intervention / Treatment: Other: Recommendations and reorientation towards healthcare resources

Detailed Description

This study includes two phases. The first phase is a feasibility study that aims to assess the behavior of users in relation to digital tools. Phase 2 will focus on evaluating the effects of the recommendations.

• Study Type: Interventional
• Enrollment (Actual): 115
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montréal, Quebec, Canada, H3W 1W5
      • CRIUGM

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Be 65 years old or older.
• Have been previously diagnosed of MNCD (major neurocognitive disorder).
• Have a caregiver.
• Live in Montreal.
• Live at home or in a residence for seniors (RPA) in a non-medicalized area.
• Have an internet connection.
• Have a computer, or a touch pad or a smart phone.
• Understand French or English orally and in writing. The speakers are French and/or English speaking, and the questionnaires are only available in these 2 languages.

Exclusion Criteria:

• Participate in a concurrent investigational clinical study, to avoid interference with our study
• Live in a Residential and Long-Term Care Center (CHSDL) or in a medical sector in an RPA

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; Phase 1; Participants will assess their health status, at home, at recruitment (M0) and at 3 months (M3) with CARE© with the help of their family caregivers.; The principal investigator or a representative will contact them by phone within 5 days of the CARE© assessment to complete ESOGER. Phase 2; Participants will assess their health status, at home, at recruitment (M0), at 3 months (M3), and at 6 months (M6) on the CARE© application with the help of their family caregivers. An additional assessment will take place over the phone by the principal investigator or one of his representatives.; If their health status is considered fragile, then individuals will be contacted by phone by the PI or one of his representatives to complete the ESOGER© questionnaire (at M0, M3 and M6).	Other: Recommendations and reorientation towards healthcare resources; Phase 1; After completing the CARE© questionnaire, participants will be given recommendations.; After the ESOGER© assessment, the participants will be contacted by the Red Cross who will set up the necessary interventions. They will be informed of the results of the assessments made. Phase 2; After completing the CARE© questionnaire, participants will be given recommendations.; If their health status is judged fragile by the CARE© score, and after the ESOGER© assessment, the participants will be contacted by the Red Cross who will set up the necessary interventions. They will be informed of the results of the assessments. For both phases, after 3 (6) months, the participants of the Control group will benefit from the recommendations following the CARE© assessment done at M3 (M6), and if necessary from the ESOGER© assessment and the Red Cross intervention. Throughout the study, they will continue to receive their conventional care.
No Intervention: Control group; Phase 1; Participants will assess their health status, by telephone, at recruitment (M0) and at 3 months (M3) with CARE© with the help of their family caregivers.; The principal investigator or a representative will contact them by phone within 5 days of the CARE© assessment to complete ESOGER. Phase 2; Participants will assess their health status, at home, at recruitment (M0), at 3 months (M3), and at 6 months (M6) on the CARE© application with the help of their family caregivers. An additional assessment will take place over the phone by the principal investigator or one of his representatives.; If their health status is considered fragile, then individuals will be contacted by phone by the PI or one of his representatives to complete the ESOGER© questionnaire (at M0, M3 and M6).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CARE© Score	Measure of frailty via a standardized self-questionnaire consisting of 22 simple questions. The CARE© score ranges from 0 (no deficits) to 21 (maximum cumulative deficits). This score has been segmented into 3 levels according to a validated approach in order to determine 3 levels of frailty which are : The robust level: score between 0 and 1.; The pre-fragile level: score between 2 and 4.; The fragile level: score > 5. For phase 1 : evaluated at M0 and M3, and the variation between M0 and M3. For phase 2 : evaluated at M0, M3 and M6, and the variation between the three periods.	8 months
Response Rate to CARE© questionnaires	Response Rate to CARE© questionnaires and the time required to complete the questionnaires. For phase 1 only.	4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
BGA Score	Measure of physical frailty using the Brief Geriatric Assessment (BGA) questionnaire with a score that ranges from 0 (no fragility) to 14 (severe fragility). For both phases.	8 months
COVID-19 symptoms	COVID-19 symptoms assessed through binary questions, asking presence or not of fever (≥ 38 Celsius), cough, shortness of breath and other symptoms. For both phases.	8 months
Psychological stress	Psychological stress is assessed using a verbal anxiety scale (EVA in French) ranging from 0 (no anxiety) to 10 (severe anxiety). For both phases.	8 months
Social Isolation	Social isolation is assessed through accessibility to medication, food and home care. For both phases.	8 months
Caregiver burden	Caregiver burden using the 4-item scale of the Caregiver Burden Interview. For both phases.	8 months
Number of completed questionnaires and recommendations given	By summing up the number of completed questionnaires and recommendations given. For both phases.	8 months
Number of recommendations followed by participants	By summing up the number of recommendations followed by participants. For both phases.	8 months
Loss of autonomy	The level of loss of autonomy is assessed by two scales : Activities of Daily Living (ADL) scale score from 0 (very dependent) to 6 (very independent); Instrumental Activities of Daily Living (IADL) scale score from 0 (not autonomous) to 4 (autonomous) For both phases.	8 months
Quality of life of participants	Quality of life is assessed by EuroQol-5D (EQ-5D), a standardized measure of health developped by EuroQol group. EQ-5D is composed of two parts : a short survey with 5 questions giving a score from 1 (no problem) to 5 (severe problem); a visual scale that ranges from 0 (worst health that participant can ever imagine) to 100 (best health participant can ever imagine). For both phases.	8 months
Consumption of services and care resources	Consumption of services and care resources measured by : the intervention (number and type) in the participant home of one or more community organizations; the number and type of consultations made with a professional (doctor, nurse, physiotherapist, etc.) reported by the caregiver; the number of visits to the emergency department and the number of hospitalizations reported by the caregiver. For both phases.	8 months

Collaborators and Investigators

• Sponsor: Centre integre universitaire de sante et de services sociaux du Centre-Sud-de-l'Île-de-Montréal

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2022
• Primary Completion (Actual): September 29, 2023
• Study Completion (Actual): September 29, 2023

Study Registration Dates

• First Submitted: October 5, 2022
• First Submitted That Met QC Criteria: October 6, 2022
• First Posted (Actual): October 7, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 10, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: E-Health
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Pathologic Processes; Frailty; Dementia; Neurocognitive Disorders
• Other Study ID Numbers: 2023-1625

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
• product manufactured in and exported from the U.S.: No