- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06606353
Talk-to-Jo" Intelligent Digital Health Companion, Neurocognitive Disorders and Dyads
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.
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Olivier Beauchet, MD
- Phone Number: 3637 5143403540
- Email: olivier.beauchet@umontreal.ca
Study Locations
-
-
Quebec
-
Montreal, Quebec, Canada, H3W1W5
- Recruiting
- CRIUGM
-
Contact:
- Olivier Beauchet, MD, PhD
- Phone Number: 3637 514 340 3540
- Email: olivier.beauchet@umontreal.ca
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Dyad
people with neurocognitive disorders and their carers with an intelligent digital health companion
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Intervention day, during 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.
|
Intervention day, during 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.
|
Intervention day, during 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.
|
Intervention day, during 15 minutes
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2025-2225
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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