Major Neurocognitive DisorderTNCMNCT05571553

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

A study testing Recommendations and reorientation towards healthcare resources in people with Major Neurocognitive Disorder and Frailty, run by Centre integre universitaire de sante et de services sociaux du Centre-Sud-de-l'Île-de-Montréal at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 65 years and older
Conditions the study is for: Major Neurocognitive Disorder, Frailty
What is being tested?: Recommendations and reorientation towards healthcare resources
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 115 participants
Where: 1 siteCanada
Study dates: 1 Dec 2022to 29 Sep 2023
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 65 years and older
All sexes
No healthy volunteers
Older adult

Who may be able to join

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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Canada1 site

CRIUGM
Montreal, Quebec, H3W 1W5

Other trials in Canada

About this study

Official title: E-health and People Living With Major Neurocognitive Disorder: A Study of the Effects of the 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).

Read the 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
Being tested: Recommendations and reorientation towards healthcare resources
Keywords: E-Health
Medical subject headings: Frailty

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Recommendations and reorientation towards healthcare resourcesOther
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.

Study groups in NCT05571553
Study group	Role	What they receive
Intervention group	Experimental	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). Receives: Other: Recommendations and reorientation towards healthcare resources
Control group	No intervention	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).

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 8 months
Response Rate to CARE© questionnaires
Response Rate to CARE© questionnaires and the time required to complete the questionnaires.
For phase 1 only.
Measured: 4 months

Secondary outcomes (10)

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.
Measured: 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.
Measured: 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.
Measured: 8 months
Social Isolation
Social isolation is assessed through accessibility to medication, food and home care.
For both phases.
Measured: 8 months
Caregiver burden
Caregiver burden using the 4-item scale of the Caregiver Burden Interview.
For both phases.
Measured: 8 months
Number of completed questionnaires and recommendations given
By summing up the number of completed questionnaires and recommendations given.
For both phases.
Measured: 8 months
Number of recommendations followed by participants
By summing up the number of recommendations followed by participants.
For both phases.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 8 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Dec 202229 Sep 2023

First posted7 Oct 2022
Study start1 Dec 2022
Primary completion29 Sep 2023
Study completion29 Sep 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Major Neurocognitive DisorderStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
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
Masking: Single blind
Who is masked: Investigator
Enrolment: 115 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05571553
Sponsor's protocol ID: 2023-1625
Acronym: TNCM
Status last verified: Feb 2025
First submitted: 5 Oct 2022
Last updated: 12 Feb 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Major Neurocognitive Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: E-health and People Living With Major Neurocognitive Disorder: A Study of the Effects of the CARE© and ESOGER© Applications
ClinicalTrials.gov ID: NCT05571553
Acronym / sponsor ID: TNCM / 2023-1625
Conditions: Major Neurocognitive Disorder, Frailty
Keywords: E-Health
Study type: Interventional
Recruitment status: Completed
Enrolment: 115 participants (actual)
Lead sponsor: Centre integre universitaire de sante et de services sociaux du Centre-Sud-de-l'Île-de-MontréalOther government
Study start: 1 Dec 2022 (actual)
Primary completion: 29 Sep 2023 (actual)
Study completion: 29 Sep 2023 (actual)
First posted: 7 Oct 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed description

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (investigator)
Number of arms: 2
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

Arm	Type	Receives
Intervention group	Experimental	Other: Recommendations and reorientation towards healthcare resourcesPhase 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).
Control group	No intervention	–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).

Who may qualify

Ages: 65 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Older adult

Key inclusion criteria (8 listed)

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.

Key exclusion criteria (2 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Recommendations and reorientation towards healthcare resourcesPhase 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.	Other	Intervention group

Primary outcome

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.
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.

10 secondary outcomes

BGA Score
Time frame: 8 months
COVID-19 symptoms
Time frame: 8 months
Psychological stress
Time frame: 8 months
Social Isolation
Time frame: 8 months
Caregiver burden
Time frame: 8 months
Number of completed questionnaires and recommendations given
Time frame: 8 months
Number of recommendations followed by participants
Time frame: 8 months
Loss of autonomy
Time frame: 8 months
Quality of life of participants
Time frame: 8 months
Consumption of services and care resources
Time frame: 8 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2025.
Individual participant dataSharing planned: No

Related trials for Major Neurocognitive Disorder

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

CARE© Score (time frame: 8 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05571553.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2025.