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Completed

NCT Number: NCT05571553

E-health and People Living With Major Neurocognitive Disorder - 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).

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Key information

Conditions

Major Neurocognitive Disorder Frailty Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CRIUGM

Montreal, Quebec, H3W 1W5, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Recommendations and reorientation towards healthcare resources

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.

Primary outcomes

  1. CARE© Score

    Time frame: 8 months

    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.

  2. Response Rate to CARE© questionnaires

    Time frame: 4 months

    Response Rate to CARE© questionnaires and the time required to complete the questionnaires.

    For phase 1 only.

Secondary outcomes

  1. BGA Score

    Time frame: 8 months

    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.

  2. COVID-19 symptoms

    Time frame: 8 months

    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.

  3. Psychological stress

    Time frame: 8 months

    Psychological stress is assessed using a verbal anxiety scale (EVA in French) ranging from 0 (no anxiety) to 10 (severe anxiety).

    For both phases.

  4. Social Isolation

    Time frame: 8 months

    Social isolation is assessed through accessibility to medication, food and home care.

    For both phases.

  5. Caregiver burden

    Time frame: 8 months

    Caregiver burden using the 4-item scale of the Caregiver Burden Interview.

    For both phases.

  6. Number of completed questionnaires and recommendations given

    Time frame: 8 months

    By summing up the number of completed questionnaires and recommendations given.

    For both phases.

  7. Number of recommendations followed by participants

    Time frame: 8 months

    By summing up the number of recommendations followed by participants.

    For both phases.

  8. Loss of autonomy

    Time frame: 8 months

    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.

  9. Quality of life of participants

    Time frame: 8 months

    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.

  10. Consumption of services and care resources

    Time frame: 8 months

    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.

Sponsors and collaborators

Lead sponsor

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

Other Gov

Registry information

Official study title

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

Acronym: TNCM

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Oct 7, 2022
Registry last updated
Feb 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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