Clinical trial NCT03468647: Seamless Follow up and Support System for Frail Elderly Living at Home
Official title: FRAGIL-IT, Seamless Follow up and Support System for Frail Elderly Living at Home
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Elderly
Keywords: frailty
tele-monitoring
self-management
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2018-03-16
Enrollment: 40
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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.

Eligibility 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.

Primary outcomes:
measure: acceptability of FRAGIL-IT tools
timeFrame: 3 months
Secondary outcomes:
measure: evaluation of life quality with SF36 questionnaire
timeFrame: 3 months
measure: functional status measure by ADL
timeFrame: 3 months
measure: functional status measure by iADL
timeFrame: 3 months
measure: cognitive status
timeFrame: 3 months
Other outcomes:
Locations:
city: Toulouse
country: France
facility: University Hospital, Toulouse
state: Midi-Pyrenes
Study officials:
affiliation: University Hospital, Toulouse
name: Antoine PIAU, MD
role: PRINCIPAL_INVESTIGATOR
References: