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

Frailty Clinical Trial

— TNCM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05571553
• Other study ID #: 2023-1625
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2022
• Est. completion date: August 10, 2024

Study information

• Verified date: February 2024
• Source: Centre integre universitaire de sante et de services sociaux du Centre-Sud-de-l'Île-de-Montréal
• Contact: Olivier Beauchet, MD
• Phone: 514-340-3540
• Email: olivier.beauchet[@]umontreal.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: August 10, 2024
• Est. primary completion date: August 10, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dementia
• Frailty
• Major Neurocognitive Disorder
• Neurocognitive Disorders

Intervention

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.

Locations

Country	Name	City	State
Canada	CRIUGM	Montréal	Quebec

Sponsors (1)

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

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	Social Isolation	Social isolation is assessed through accessibility to medication, food and home care.; For both phases.	8 months
Secondary	Caregiver burden	Caregiver burden using the 4-item scale of the Caregiver Burden Interview.; For both phases.	8 months
Secondary	Number of completed questionnaires and recommendations given	By summing up the number of completed questionnaires and recommendations given.; For both phases.	8 months
Secondary	Number of recommendations followed by participants	By summing up the number of recommendations followed by participants.; For both phases.	8 months
Secondary	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
Secondary	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
Secondary	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