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Predictive Platform for PEople aGed and Requiring ASsistancE (3PEGASE)

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ClinicalTrials.gov Identifier: NCT03484156
Recruitment Status : Recruiting
First Posted : March 30, 2018
Last Update Posted : October 30, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse

Brief 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 detect early infra-clinical disability.

Condition or disease Intervention/treatment Phase
Aging Device: Installation of 3PEGASE Sensor Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Predictive Platform for PEople aGed and Requiring ASsistancE
Actual Study Start Date : September 1, 2017
Estimated Primary Completion Date : July 1, 2019
Estimated Study Completion Date : July 1, 2020

Arm Intervention/treatment
Experimental: Volunteers

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.

Device: Installation of 3PEGASE Sensor
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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. The relevance of each alert according to the subjective opinion [ Time Frame: 6 months ]

    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.



Other Outcome Measures:
  1. The occurrence of major clinical events [ Time Frame: 6 months ]
    The occurrence of major clinical events collected by the Clinical Research Assistant every 2 months a clinical event that required to bring in a doctor, firefighters, a call to 15 or at SOS doctor, a transport to an emergency service

  2. The functional autonomy [ Time Frame: 6 months ]
    The functional autonomy measured every 2 months by the Activities of Daily Living (ADL) score

  3. The cognitive autonomy [ Time Frame: 6 months ]
    The cognitive autonomy measured every two months by the Mini Mental State Examination (MMSE) score



Information from the National Library of Medicine

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Ages Eligible for Study:   75 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • patient aged 75 or more, living alone at home
  • frail of disable (ADL superior or equal at 3)
  • able to walk by themselves

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03484156


Contacts
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Contact: Antoine Piau, MD 05 61 32 30 10 ext 33 piau.a@chu-toulouse.fr
Contact: Aline Meulle, PhD 05 61 77 70 87 ext 33 meulle.a@chu-toulouse.fr

Locations
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France
University Hospital, Toulouse Recruiting
Toulouse, Midi-Pyrenes, France, 31059
Contact: Antoine PIAU, MD    0561323010 ext 33    piau.a@chu-toulouse.fr   
Contact: Fati NOURHASHEMI, MD    0561776469 ext 33    nourhashemi.f@chu-toulouse.fr   
CHU Toulouse Recruiting
Toulouse, France, 31059
Contact: Aline Meulle, PhD    05 61 77 70 87 ext 33    meulle.a@chu-toulouse.fr   
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
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Principal Investigator: Antoine Piau, MD Toulouse CHU

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Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT03484156     History of Changes
Other Study ID Numbers: RC31/15/7803
First Posted: March 30, 2018    Key Record Dates
Last Update Posted: October 30, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Toulouse:
Elderly
Frailty
Tele-monitoring
Disability