CaregiverNCT06606353
Talk-to-Jo" Intelligent Digital Health Companion, Neurocognitive Disorders and Dyads
An observational study of Caregiver and Neurocognitive Disorders, run by Olivier Beauchet at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Caregiver, Neurocognitive Disorders
- What is being tested?
- Talk-To-Jo
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- 12 Dec 2024to Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: dyads composed of people living with NCD and their caregiver
- Person living with an neurocognitive disorder (NCD):
- Inclusion criteria:
- 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.
- Exclusion criteria:
- 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
- Inclusion criteria:
- 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.
- Exclusion criteria:
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
CRIUGM
Montreal, Quebec, H3W1W5
Olivier Beauchet, MD, PhD, 514 340 3540 ext. 3637, olivier.beauchet@umontreal.ca
About this study
Official title: Talk-to-Jo" Intelligent Digital Health Companion, Neurocognitive Disorders and Dyads: a Qualitative Study
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.
Read more
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.
- Conditions
- Caregiver, Neurocognitive Disorders
- Being tested
- Talk-To-Jo
- Medical subject headings
- Neurocognitive Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Talk-To-JoBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Dyad | people with neurocognitive disorders and their carers with an intelligent digital health companion Receives: Behavioral: Talk-To-Jo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Intervention day, during 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2024
- Study start12 Dec 2024
- Primary completionFeb 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CaregiverStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Olivier Beauchet
- Sponsor type
- Other government
- Collaborators
- Centre integre universitaire de sante et de services sociaux du Centre-Sud-de-l'Île-de-Montréal
- Responsible party
- Sponsor-investigator, Olivier Beauchet, Centre integre universitaire de sante et de services sociaux du Centre-Sud-de-l'Île-de-Montréal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06606353
- Sponsor's protocol ID
- 2025-2225
- Status last verified
- Feb 2025
- First submitted
- 18 Sep 2024
- Last updated
- 12 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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
- Talk-to-Jo" Intelligent Digital Health Companion, Neurocognitive Disorders and Dyads: a Qualitative Study
- ClinicalTrials.gov ID
- NCT06606353
- Acronym / sponsor ID
- 2025-2225
- Conditions
- Caregiver, Neurocognitive Disorders
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Olivier BeauchetOther government
- Collaborators
- Centre integre universitaire de sante et de services sociaux du Centre-Sud-de-l'Île-de-Montréal
- Study start
- 12 Dec 2024 (actual)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 23 Sep 2024 (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.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dyad | – | Behavioral: Talk-To-Jopeople with neurocognitive disorders and their carers with an intelligent digital health companion |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- dyads composed of people living with NCD and their caregiver
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 |
|---|---|---|
| Talk-To-JoParticipation 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. | Behavioural | Dyad |
Primary outcome
usage behaviours
Time frame: Intervention day, during 15 minutes
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.
impressions and feedback from people living with an NCD and their caregivers (PPA)
Time frame: Intervention day, during 15 minutes
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.
enablers and barriers to the use of the intelligent digital avatar "Talk-to-Jo."
Time frame: Intervention day, during 15 minutes
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.
expectations and needs of people living with an NCD and their caregivers
Time frame: Intervention day, during 15 minutes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2025.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Caregiver and Neurocognitive Disorders, run by Olivier Beauchet at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: looking for participants now, 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Olivier Beauchet, MD (5143403540 ext. 3637, olivier.beauchet@umontreal.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
usage behaviours (time frame: Intervention day, during 15 minutes). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.