An interventional study of Recommendations and reorientation towards healthcare resources in Major Neurocognitive Disorder and Frailty, sponsored by Centre integre universitaire de sante et de services sociaux du Centre-Sud-de-l'Île-de-Montréal. Completed at 1 site in Canada. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2025-02-12.
Sponsored by Centre integre universitaire de sante et de services sociaux du Centre-Sud-de-l'Île-de-Montréal · Not applicable, Interventional, and Other
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 :
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).
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.
2,172 studies on the registry are indexed under Dementia; 540 are open to participants now.
This study's enrollment of 115 is above the median of 83 across 1,629 interventional studies indexed under Dementia.
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Exclusion Criteria:
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 * 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).
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.
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.
Time frame: 8 months
Response Rate to CARE© questionnaires
Response Rate to CARE© questionnaires and the time required to complete the questionnaires. For phase 1 only.
Time frame: 4 months
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.
Time frame: 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.
Time frame: 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.
Time frame: 8 months
Social Isolation
Social isolation is assessed through accessibility to medication, food and home care. For both phases.
Time frame: 8 months
Caregiver burden
Caregiver burden using the 4-item scale of the Caregiver Burden Interview. For both phases.
Time frame: 8 months
Number of completed questionnaires and recommendations given
By summing up the number of completed questionnaires and recommendations given. For both phases.
Time frame: 8 months
Number of recommendations followed by participants
By summing up the number of recommendations followed by participants. For both phases.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 8 months
Plan to share: No
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Centre integre universitaire de sante et de services sociaux du Centre-Sud-de-l'Île-de-Montréal