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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03468647
Recruitment Status : Active, not recruiting
First Posted : March 16, 2018
Last Update Posted : July 12, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse

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.

Condition or disease Intervention/treatment Phase
Elderly Other: soles Other: weighting machine Other: gripping force Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: FRAGIL-IT, Seamless Follow up and Support System for Frail Elderly Living at Home
Actual Study Start Date : October 16, 2017
Actual Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2019

Arm Intervention/treatment
Experimental: FRAGIL-IT testing group
FRAGIL-IT tools : connected soles, connected weighting machine and measure of gripping force
Other: soles
Volunteer must walk this this connected seamless to measure different walking parameters
Other Name: connected soles

Other: weighting machine
This weighting machine measure weight evolution and equilibrate of volunteers
Other Name: connected weighting machine

Other: gripping force
this machine measure the gripping force of volunteer
Other Name: gripping force machine




Primary Outcome Measures :
  1. acceptability of FRAGIL-IT tools [ Time Frame: 3 months ]
    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


Secondary Outcome Measures :
  1. evaluation of life quality with SF36 questionnaire [ Time Frame: 3 months ]
    the life quality will be assess with SF36 questionnaire

  2. functional status measure by ADL [ Time Frame: 3 months ]
    functional status will be assess with Activity of Daily Living (ADL) score. The scale of ADL is between 0 to 6. 0 is worse than 6.

  3. functional status measure by iADL [ Time Frame: 3 months ]
    functional status will be assess with instrumental Activity of Daily Living (iADL) score. The scale of IADL is between 0 to 8. 0 is worse than 8.

  4. cognitive status [ Time Frame: 3 months ]
    cognitive status will be assess with Mini Mental State (MMS)



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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): NCT03468647


Locations
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France
University Hospital, Toulouse
Toulouse, Midi-Pyrenes, France, 31059
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
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Principal Investigator: Antoine PIAU, MD University Hospital, Toulouse

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Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT03468647     History of Changes
Other Study ID Numbers: RC31/15/0603
First Posted: March 16, 2018    Key Record Dates
Last Update Posted: July 12, 2019
Last Verified: July 2019

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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:
frailty
tele-monitoring
self-management