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

NCT ID: NCT03468647

Last Updated: 2020-11-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-16

Study Completion Date

2019-12-31

Brief Summary

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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

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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

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Elderly

Keywords

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frailty tele-monitoring self-management

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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FRAGIL-IT testing group

FRAGIL-IT tools : connected soles, connected weighting machine and measure of gripping force

Group Type EXPERIMENTAL

soles

Intervention Type OTHER

Volunteer must walk this this connected seamless to measure different walking parameters

weighting machine

Intervention Type OTHER

This weighting machine measure weight evolution and equilibrate of volunteers

gripping force

Intervention Type OTHER

this machine measure the gripping force of volunteer

Interventions

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soles

Volunteer must walk this this connected seamless to measure different walking parameters

Intervention Type OTHER

weighting machine

This weighting machine measure weight evolution and equilibrate of volunteers

Intervention Type OTHER

gripping force

this machine measure the gripping force of volunteer

Intervention Type OTHER

Other Intervention Names

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connected soles connected weighting machine gripping force machine

Eligibility Criteria

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Inclusion Criteria

* patient living at home;
* pre-frail or frail volunteers;
* Informed and written consent by the patient or the legal representative or the reliable person when appropriate.

Exclusion Criteria

* patient's life expectancy less than 12 months; patient presenting disability with an Activity of Daily Living score \< 4/6 ant/or a Mini - Mental State \<20/30, not walking or walking with a technical support;
* Non agreement of study participation of patients or legal representative or the reliable person when appropriate.
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Toulouse

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Antoine PIAU, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Toulouse

Locations

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University Hospital, Toulouse

Toulouse, Midi-Pyrenes, France

Site Status

Countries

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France

Other Identifiers

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RC31/15/0603

Identifier Type: -

Identifier Source: org_study_id