Seamless Follow up and Support System for Frail Elderly Living at Home (FRAGIL-IT)
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|ClinicalTrials.gov Identifier: NCT03468647|
Recruitment Status : Active, not recruiting
First Posted : March 16, 2018
Last Update Posted : July 12, 2019
|Condition or disease||Intervention/treatment||Phase|
|Elderly||Other: soles Other: weighting machine Other: gripping force||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
Experimental: FRAGIL-IT testing group
FRAGIL-IT tools : connected soles, connected weighting machine and measure of gripping force
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
- 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
- evaluation of life quality with SF36 questionnaire [ Time Frame: 3 months ]the life quality will be assess with SF36 questionnaire
- 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.
- 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.
- cognitive status [ Time Frame: 3 months ]cognitive status will be assess with Mini Mental State (MMS)
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
|University Hospital, Toulouse|
|Toulouse, Midi-Pyrenes, France, 31059|
|Principal Investigator:||Antoine PIAU, MD||University Hospital, Toulouse|