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
|Condition or disease||Intervention/treatment||Phase|
|Aging||Device: Installation of 3PEGASE Sensor||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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
- 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.
- 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
- The functional autonomy [ Time Frame: 6 months ]The functional autonomy measured every 2 months by the Activities of Daily Living (ADL) score
- The cognitive autonomy [ Time Frame: 6 months ]The cognitive autonomy measured every two months by the Mini Mental State Examination (MMSE) score
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
|Contact: Antoine Piau, MD||05 61 32 30 10 ext email@example.com|
|Contact: Aline Meulle, PhD||05 61 77 70 87 ext firstname.lastname@example.org|
|University Hospital, Toulouse||Recruiting|
|Toulouse, Midi-Pyrenes, France, 31059|
|Contact: Antoine PIAU, MD 0561323010 ext 33 email@example.com|
|Contact: Fati NOURHASHEMI, MD 0561776469 ext 33 firstname.lastname@example.org|
|Toulouse, France, 31059|
|Contact: Aline Meulle, PhD 05 61 77 70 87 ext 33 email@example.com|
|Principal Investigator:||Antoine Piau, MD||Toulouse CHU|