Aging3PEGASENCT03484156
Predictive Platform for PEople aGed and Requiring ASsistancE
A study testing Installation of 3PEGASE Sensor in people with Aging, run by University Hospital, Toulouse at 2 sites in France.
Trial summary
The study aim is to assess the capacity of a technological solution for analyzing older person's functional and cognitive autonomy at home. Results from this study will also be used to elaborate the design of a further larger national multicenter randomized control trial assessing the efficacy of the solution to… Read more about this study
- Who is it for?
- Ages 75 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- Installation of 3PEGASE Sensor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 2 sitesFrance
- Study dates
- 1 Sep 2017to 1 Jul 2019
- 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 75 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- patient aged 75 or more, living alone at home
- frail of disable (ADL superior or equal at 3)
- able to walk by themselves
Who cannot join
- patient presenting a Mini Mental State lower at 16/30 and without a daily intervention from a caregiver
- non agreement of study participation of patients or the reliable person when appropriate.
Trial locations and contacts
2 sites in 1 country.
France2 sites
University Hospital, Toulouse
Toulouse, Midi-Pyrenes, 31059
CHU Toulouse
Toulouse, 31059
About this study
The study aim is to assess the capacity of a technological solution for analyzing older person's functional and cognitive autonomy at home. Results from this study will also be used to elaborate the design of a further larger national multicenter randomized control trial assessing the efficacy of the solution to detect early infra-clinical disability.
Read the detailed description
The object of the present project is to evaluate an instrument for monitoring functional and cognitive autonomy in frail or disable elderly persons living alone at home. By assessing older person's autonomy at home and detecting early infra-clinical indicators, the solution could provide relevant clinical parameters to the caregivers and healthcare professionals in order to support the patient's follow-up, and support the detection of preliminary signs of functional loss. The device consists of a set of sensors embedded in the house with minimal invasiveness. The solution transmits the collected data to a remote storage server. Data will then be available for distance consultations by users (i.e., patients, careers or physicians). The study will conduct a wide range of evaluations of the device (technical, clinical, and economic), which will allow the optimization of the prototype. The evaluation of the solution will involve 25 frail or disable community-dwelling subjects living alone for 6 months. Comprehensive assessments will be conducted to highlight the feasibility, integration in healthcare network, and clinical relevance of the technological device.
- Conditions
- Aging
- Being tested
- Installation of 3PEGASE Sensor
- Keywords
- Elderly, Frailty, Tele-monitoring, Disability
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Installation of 3PEGASE SensorDevice
Volunteers will be equipped with the 3-PEGASE solution to monitor clinical indicators at home : By assessing older person's autonomy at home and detecting early infra-clinical indicators, the solution could provide relevant clinical parameters to the caregivers and healthcare professionals in order to support the patient's follow-up, and support the detection of preliminary signs of functional loss
| Study group | Role | What they receive |
|---|---|---|
| Volunteers | Experimental | The Installation of 3PEGASE Sensor in elders volunteers to monitor clinical indicators at home.The instrument is for monitoring functional and cognitive autonomy in frail or disable elderly persons living alone at home.
The volunteers will have 70 years old or more, living alone at home, frail of disable (ADL> or =3) and able to walk by themselves. Receives: Device: Installation of 3PEGASE Sensor |
What is being measured
The primary outcome is the main question the study is designed to answer.
The occurrence of alerts
The occurrence of alerts : each alert will be recorded to characterize the number and the pace of alerts during the time of follow-up
Measured: 6 months
Secondary outcomes (1)
The relevance of each alert according to the subjective opinion
The relevance of each alert if it's legitimate or not legitimate according to the subjective opinion of ; the investigator and the voluntary subject The "Classic" alerts (volunteers on behalf of the person being followed) generated by the system will be defined as valid or invalid on the basis of the carers' assessment: "was he legitimate to alert you? And professionals (assistance).
The "automatic" alerts generated by the sensors will be defined as valid or not on the basis of the assessment of the tele-assistant, the carer and the voluntary subject.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2018
- Study start1 Sep 2017
- Primary completion1 Jul 2019
- Study completion1 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AgingStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antoine Piau, MD, Principal investigator, Toulouse CHU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03484156
- Sponsor's protocol ID
- RC31/15/7803
- Acronym
- 3PEGASE
- Status last verified
- Jul 2019
- First submitted
- 15 Jun 2017
- Last updated
- 12 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Piau A, Lepage B, Bernon C, Gleizes MP, Nourhashemi F. Real-Time Detection of Behavioral Anomalies of Older People Using Artificial Intelligence (The 3-PEGASE Study): Protocol for a Real-Life Prospective Trial. JMIR Res Protoc. 2019 Nov 18;8(11):e14245. doi: 10.2196/14245.
PubMed 31738180
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Platform for PEople aGed and Requiring ASsistancE
- ClinicalTrials.gov ID
- NCT03484156
- Acronym / sponsor ID
- 3PEGASE / RC31/15/7803
- Conditions
- Aging
- Keywords
- Elderly, Frailty, Tele-monitoring, Disability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 1 Jul 2019 (actual)
- Study completion
- 1 Jul 2019 (actual)
- First posted
- 30 Mar 2018 (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.
The study aim is to assess the capacity of a technological solution for analyzing older person's functional and cognitive autonomy at home. Results from this study will also be used to elaborate the design of a further larger national multicenter randomized control trial assessing the efficacy of the solution to detect early infra-clinical disability.
Detailed description
The object of the present project is to evaluate an instrument for monitoring functional and cognitive autonomy in frail or disable elderly persons living alone at home. By assessing older person's autonomy at home and detecting early infra-clinical indicators, the solution could provide relevant clinical parameters to the caregivers and healthcare professionals in order to support the patient's follow-up, and support the detection of preliminary signs of functional loss. The device consists of a set of sensors embedded in the house with minimal invasiveness. The solution transmits the collected data to a remote storage server. Data will then be available for distance consultations by users (i.e., patients, careers or physicians). The study will conduct a wide range of evaluations of the device (technical, clinical, and economic), which will allow the optimization of the prototype. The evaluation of the solution will involve 25 frail or disable community-dwelling subjects living alone for 6 months. Comprehensive assessments will be conducted to highlight the feasibility, integration in healthcare network, and clinical relevance of the technological device.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Volunteers | Experimental | Device: Installation of 3PEGASE SensorThe Installation of 3PEGASE Sensor in elders volunteers to monitor clinical indicators at home.The instrument is for monitoring functional and cognitive autonomy in frail or disable elderly persons living alone at home. The volunteers will have 70 years old or more, living alone at home, frail of disable (ADL> or =3) and able to walk by themselves. |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- patient aged 75 or more, living alone at home
- frail of disable (ADL superior or equal at 3)
- able to walk by themselves
Key exclusion criteria (2 listed)
- patient presenting a Mini Mental State lower at 16/30 and without a daily intervention from a caregiver
- non agreement of study participation of patients or the reliable person when appropriate.
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 |
|---|---|---|
| Installation of 3PEGASE SensorVolunteers will be equipped with the 3-PEGASE solution to monitor clinical indicators at home : By assessing older person's autonomy at home and detecting early infra-clinical indicators, the solution could provide relevant clinical parameters to the caregivers and healthcare professionals in order to support the patient's follow-up, and support the detection of preliminary signs of functional loss | Device | Volunteers |
Primary outcome
The occurrence of alerts
Time frame: 6 months
The occurrence of alerts : each alert will be recorded to characterize the number and the pace of alerts during the time of follow-up
1 secondary outcome
The relevance of each alert according to the subjective opinion
Time frame: 6 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 Jul 2019.
- Derived from this study: PubMed 31738180Piau A, Lepage B, Bernon C, Gleizes MP, Nourhashemi F. Real-Time Detection of Behavioral Anomalies of Older People Using Artificial Intelligence (The 3-PEGASE Study): Protocol for a Real-Life Prospective Trial. JMIR Res Protoc. 2019 Nov 18;8(11):e14245. doi: 10.2196/14245.
- Individual participant dataSharing planned: No
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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.
Antoine Piau, MD principal investigator
Toulouse CHU
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Installation of 3PEGASE Sensor in people with Aging, run by University Hospital, Toulouse at 2 sites in France.
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 3 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 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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?
The occurrence of alerts (time frame: 6 months). 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 NCT03484156, which also lists 1 linked publication.
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 Jul 2019.