NCT03468647

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 13, 2017

Completed
3 days until next milestone

Study Start

First participant enrolled

October 16, 2017

Completed
5 months until next milestone

First Posted

Study publicly available on registry

March 16, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

November 9, 2020

Status Verified

November 1, 2020

Enrollment Period

1.2 years

First QC Date

October 13, 2017

Last Update Submit

November 6, 2020

Conditions

Elderly

Keywords

frailtytele-monitoringself-management

Outcome Measures

Primary Outcomes (1)

  • acceptability of FRAGIL-IT tools

    primary outcome is based on the acceptability of the FRAGIL-IT tools for the end-user : connected soles, connected weighting machine and measure of gripping force to control autonomy loss. The acceptability of this tools will be evaluate by questionnaire as The Short Form (36) Health Survey (SF36) questionnaire

    3 months

Secondary Outcomes (4)

  • evaluation of life quality with SF36 questionnaire

    3 months

  • functional status measure by ADL

    3 months

  • functional status measure by iADL

    3 months

  • cognitive status

    3 months

Study Arms (1)

FRAGIL-IT testing group

EXPERIMENTAL

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

Other: solesOther: weighting machineOther: gripping force

Interventions

solesOTHER

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

Also known as: connected soles
FRAGIL-IT testing group
weighting machineOTHER

This weighting machine measure weight evolution and equilibrate of volunteers

Also known as: connected weighting machine
FRAGIL-IT testing group
gripping forceOTHER

this machine measure the gripping force of volunteer

Also known as: gripping force machine
FRAGIL-IT testing group

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital, Toulouse

Toulouse, Midi-Pyrenes, 31059, France

Location

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Antoine PIAU, MD

    University Hospital, Toulouse

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 13, 2017

First Posted

March 16, 2018

Study Start

October 16, 2017

Primary Completion

December 31, 2018

Study Completion

December 31, 2019

Last Updated

November 9, 2020

Record last verified: 2020-11

Locations

FR(1)