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

NCT ID: NCT05571553

Last Updated: 2025-02-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 115 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-01
• Study Completion Date: 2023-09-29

Brief Summary

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).

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.

Conditions

Major Neurocognitive Disorder; Frailty

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

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).

Group Type: EXPERIMENTAL

Recommendations and reorientation towards healthcare resources

Intervention Type: OTHER

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.

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).

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

OTHER_GOV

Sponsor Role: lead

Responsible Party

Olivier Beauchet

MD, PhD, Senior researcher, Director of laboratory

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

CRIUGM

Montreal, Quebec, Canada

Countries

Canada

Other Identifiers

2023-1625

Identifier Type: -

Identifier Source: org_study_id