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Completed

NCT Number: NCT03468647

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

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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital, Toulouse

Toulouse, Midi-Pyrenes, 31059, France

About this study

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 :

  • connected soles to evaluate different parameters of the volunteer walking
  • connected weighing machine to evaluate the volunteer weight and equilibrate
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

soles

Other

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

Other names: connected soles

weighting machine

Other

This weighting machine measure weight evolution and equilibrate of volunteers

Other names: connected weighting machine

gripping force

Other

this machine measure the gripping force of volunteer

Other names: gripping force machine

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Official study title

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

Acronym: FRAGIL-IT

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Mar 16, 2018
Registry last updated
Nov 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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