Clinical Trials Directory

Trials / Completed

CompletedNCT03468647

Seamless Follow up and Support System for Frail Elderly Living at Home

FRAGIL-IT, Seamless Follow up and Support System for Frail Elderly Living at Home

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
40 (actual)
Sponsor
University Hospital, Toulouse · Academic / Other
Sex
All
Age
65 Years
Healthy volunteers
Not accepted

Summary

The object of the present project is to promote the prevention of disability by providing 1) a feedback and motivational coaching to the user, 2) relevant clinical parameters to the healthcare professionals in order to support the patient's follow-up, and 3) supporting the detection of preliminary signs of functional loss. The technical solution will contain wearable (e.g. smart insole) and ambient unobtrusive devices (e.g. weigh scale including balance analysis), and analysis and diagnosis assistance software. The devices transmit wirelessly the collected data to a remote server through a tablet. Data will then be available remotely for consultations by users (i.e. patients or physicians). The clinical evaluation will be a multi-phased design with a first living lab evaluation followed by a real life home trial to finalize the evaluation. Comprehensive assessments will be conducted to highlight the feasibility and acceptability.

Detailed description

Functional decline challenges the sustainability of healthcare systems. There are difficulties in implementing effective interventions to prevent disability, to promote adherence to lifestyle recommendations and to perform seamless follow-up at home. A technological solution addressing this challenge and improving individual participation would be welcome. Our aim is to evaluate an instrument for supporting physical activity and monitoring multiple parameters of frailty (a pre-disability condition) in frail elderly persons. The investigator and collaborator are therefore developing a solution to monitor key parameters of frailty during subject daily life and to promote walking. This tools are : 1. connected soles to evaluate different parameters of the volunteer walking 2. connected weighing machine to evaluate the volunteer weight and equilibrate 3. machine to measure gripping force because gripping force is correlated to physical condition. The primary aim is to assess the acceptability of the solution for the follow up and the motivational coaching of frail patients 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 efficiency of the solution to prevent disability.

Conditions

Interventions

TypeNameDescription
OTHERsolesVolunteer must walk this this connected seamless to measure different walking parameters
OTHERweighting machineThis weighting machine measure weight evolution and equilibrate of volunteers
OTHERgripping forcethis machine measure the gripping force of volunteer

Timeline

Start date
2017-10-16
Primary completion
2018-12-31
Completion
2019-12-31
First posted
2018-03-16
Last updated
2020-11-09

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT03468647. Inclusion in this directory is not an endorsement.