Clinical trial NCT05571553: E-health and People Living With Major Neurocognitive Disorder - CARE© and ESOGER© Applications
Official title: E-health and People Living With Major Neurocognitive Disorder: A Study of the Effects of the CARE© and ESOGER© Applications
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Major Neurocognitive Disorder
Frailty
Keywords: E-Health
Lead sponsor: Centre integre universitaire de sante et de services sociaux du Centre-Sud-de-l'Île-de-Montréal
Sponsor class: OTHER_GOV
First posted: 2022-10-07
Enrollment: 115
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Phase 1

This is an experimental study of the randomized, longitudinal, prospective clinical trial type with a 3-month follow-up, open, in parallel groups (intervention versus control), carried out in people living with an MNCD and their family caregivers.

Number of participants : 120

Phase 2

This is a randomized, longitudinal, prospective, clinical trial with a 6-month follow-up, open, in parallel groups (intervention versus control), carried out in people living with an MNCD.

The total number of participants needed will be re-evaluated following analysis of the results obtained in Phase 1. We estimate at this time that a total of 40 participants per group, for a total of 80 people, is the number of participants needed for this study
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: CARE© Score
timeFrame: 8 months
measure: Response Rate to CARE© questionnaires
timeFrame: 4 months
Secondary outcomes:
measure: BGA Score
timeFrame: 8 months
measure: COVID-19 symptoms
timeFrame: 8 months
measure: Psychological stress
timeFrame: 8 months
measure: Social Isolation
timeFrame: 8 months
measure: Caregiver burden
timeFrame: 8 months
measure: Number of completed questionnaires and recommendations given
timeFrame: 8 months
measure: Number of recommendations followed by participants
timeFrame: 8 months
measure: Loss of autonomy
timeFrame: 8 months
measure: Quality of life of participants
timeFrame: 8 months
measure: Consumption of services and care resources
timeFrame: 8 months
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: CRIUGM
state: Quebec
Study officials:
References: