NCT06606353

Brief Summary

By 2050, one in six people in the world will be over 65, leading to an increase in the number of people with neurocognitive disorders (NCD), such as Alzheimer's disease. The number of cases will rise from 57 million to 153 million by 2050. This presents challenges for healthcare systems, as NCDs affect not only mental health but also the physical health, psychological well-being, and social relationships of patients, as well as their caregivers (PCA). In Quebec, primary care is often inadequate for people living with NCDs due to delays in accessing resources, incomplete coverage of needs, and the COVID-19 pandemic, which has exacerbated these challenges. This situation can lead to a deterioration in patients' health, affecting their quality of life as well as that of their PCAs, while also increasing healthcare costs. Many elderly people wish to age at home, but cognitive and functional decline complicates this desire. PCAs, generally family members or close friends, play an essential role in the daily support of these individuals. Their role, as defined in the Act to support caregivers in Quebec, includes non-professional and voluntary assistance to improve the quality of life of the person being cared for. However, the support provided by PCAs can lead to significant stress, especially if public services are insufficient. The exhaustion of PCAs is often correlated with the severity of the care recipient's loss of autonomy. This exhaustion impacts the mental and physical health of PCAs, leading to isolation, depression, and anxiety, as well as reduced productivity and an increase in sick leave. It is therefore urgent to find support solutions to prevent PCA burnout. Telehealth, which involves remote consultations through information and communication technologies (ICT), appears to be a promising solution to improve access to care for people with NCDs, especially in underserved areas. By enabling remote monitoring, telehealth facilitates aging in place while stimulating the remaining capacities of patients, such as responsiveness to sensory stimuli. Artificial intelligence (AI) is also a promising tool for tracking the health of older adults in real-time, detecting early signs of diseases, and providing personalized recommendations. Virtual assistants or avatars, like "Talk-to-Jo," can interact with patients to reduce their sense of loneliness. However, the effectiveness of these technologies depends on their accessibility and adaptability to the needs of patients, particularly in cases of sensory impairments. "Talk-to-Jo" is a digital avatar designed for older adults with NCDs and their PCAs. It asks questions about memory and depression and provides tailored recommendations to prevent or stabilize detected disorders. A first version of this tool is currently available on a tablet. With the growing number of people living with NCDs, it is essential to develop support solutions based on telemedicine and AI. It is important to assess the usability and acceptability of these technologies by patients and their PCAs to ensure their effectiveness.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
5mo left

Started Dec 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress78%
Dec 2024Oct 2026

First Submitted

Initial submission to the registry

September 18, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 23, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

December 12, 2024

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2026

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Expected
Last Updated

February 12, 2025

Status Verified

February 1, 2025

Enrollment Period

1.1 years

First QC Date

September 18, 2024

Last Update Submit

February 10, 2025

Conditions

Outcome Measures

Primary Outcomes (4)

  • usage behaviours

    Semi-directed interviews will be conducted with both members of the dyad and by one or two members of the research team. If members of the research team observe a difference of opinion between the two members of the dyad, a complementary semi-structured interview will be conducted with each member of the dyad separately. This complementary semi-structured interview will take place if the members of the dyad agree to be separated for 10 to 15 minutes.

    Intervention day, during 15 minutes

  • impressions and feedback from people living with an NCD and their caregivers (PPA)

    Semi-directed interviews will be conducted with both members of the dyad and by one or two members of the research team. If members of the research team observe a difference of opinion between the two members of the dyad, a complementary semi-structured interview will be conducted with each member of the dyad separately. This complementary semi-structured interview will take place if the members of the dyad agree to be separated for 10 to 15 minutes.

    Intervention day, during 15 minutes

  • enablers and barriers to the use of the intelligent digital avatar "Talk-to-Jo."

    Semi-directed interviews will be conducted with both members of the dyad and by one or two members of the research team. If members of the research team observe a difference of opinion between the two members of the dyad, a complementary semi-structured interview will be conducted with each member of the dyad separately. This complementary semi-structured interview will take place if the members of the dyad agree to be separated for 10 to 15 minutes.

    Intervention day, during 15 minutes

  • expectations and needs of people living with an NCD and their caregivers

    Semi-directed interviews will be conducted with both members of the dyad and by one or two members of the research team. If members of the research team observe a difference of opinion between the two members of the dyad, a complementary semi-structured interview will be conducted with each member of the dyad separately. This complementary semi-structured interview will take place if the members of the dyad agree to be separated for 10 to 15 minutes.

    Intervention day, during 15 minutes

Study Arms (1)

Dyad

people with neurocognitive disorders and their carers with an intelligent digital health companion

Behavioral: Talk-To-Jo

Interventions

Talk-To-JoBEHAVIORAL

Participation begins with the completion of a socio-demographic questionnaire. Next, participants test the Talk-to-Jo intelligent digital health companion on a tablet: first, a member of the research team explains the tool to the dyad (person with a neurocognitive disorder and their caregiver). The person with the disorder then interacts with Talk-to-Jo, possibly with the help of their caregiver. An observer is present, but does not intervene unless there are questions or technical problems. At the end of the test, health recommendations are given. Questions focus on the participant's memory and depression. Next, a 30-minute interview is conducted with a member of the research team to gather impressions of the tool, digital skills, barriers and facilitators to using AI, as well as your expectations of Talk-to-Jo. An additional individual interview can be arranged if required.

Dyad

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

dyads composed of people living with NCD and their caregiver

You may qualify if:

  • Be 65 years old or older.
  • Have an NCD, whether minor or major, in a mild to moderate stage, diagnosed within the past year.
  • Be receiving care for an NCD at the outpatient clinic of the Montreal Geriatric University Institute.
  • Have a caregiver.
  • Live in a personal residence or in a non-medicalized senior residence.
  • Be able to understand spoken and written French. The "Talk-to-Jo" avatar has only been developed in the French language and can only communicate and understand French.

You may not qualify if:

  • Inability to provide informed consent for participation in the study.
  • Participating in a concurrent experimental clinical study, to avoid interference with our study.
  • Living in a Long-Term Care Facility or in a medicalized section of an non-medicalized senior residence.
  • Inability to understand spoken and written French.
  • Having a moderate to severe visual or auditory impairment. The criterion for assessing hearing impairment will be the person's ability to understand and participate in a phone conversation. Individuals with impairments who use hearing aids or glasses to compensate for the impairments may be included.
  • Caregiver
  • Be a caregiver for a person living with an NCD (regardless of the relationship: spouse, child, friend, neighbor, family member).
  • Be able to understand spoken and written French.
  • Have an NCD.
  • Inability to understand spoken and written French.
  • Participating in a concurrent experimental clinical study, to avoid interference with our study.
  • Having a moderate to severe visual or auditory impairment. The criterion for assessing hearing impairment will be the person's ability to understand and participate in a phone conversation. Individuals with impairments who use hearing aids or glasses to compensate for the impairments may be included.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CRIUGM

Montreal, Quebec, H3W1W5, Canada

RECRUITING

MeSH Terms

Conditions

Neurocognitive Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Central Study Contacts

Olivier Beauchet, MD

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD PhD

Study Record Dates

First Submitted

September 18, 2024

First Posted

September 23, 2024

Study Start

December 12, 2024

Primary Completion

February 1, 2026

Study Completion (Estimated)

October 1, 2026

Last Updated

February 12, 2025

Record last verified: 2025-02

Locations