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

Elderly Clinical Trial

— FRAGIL-IT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03468647
• Other study ID #: RC31/15/0603
• Status: Completed
• Phase: N/A
• Start date: October 16, 2017
• Est. completion date: December 31, 2019

Study information

• Verified date: November 2020
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Elderly

Intervention

Other:
• soles
Volunteer must walk this this connected seamless to measure different walking parameters
• weighting machine
This weighting machine measure weight evolution and equilibrate of volunteers
• gripping force
this machine measure the gripping force of volunteer

Locations

Country	Name	City	State
France	University Hospital, Toulouse	Toulouse	Midi-Pyrenes

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	evaluation of life quality with SF36 questionnaire	the life quality will be assess with SF36 questionnaire	3 months
Secondary	functional status measure by ADL	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 months
Secondary	functional status measure by iADL	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.	3 months
Secondary	cognitive status	cognitive status will be assess with Mini Mental State (MMS)	3 months