Evaluation of a Health Monitoring Platform for Elderly in Home Care Context

Study Overview
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Brief Summary
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This study aims at, as a primary objective, studying acceptability of elderly about a health monitoring platform for home support and home care. The secondary objective consists in studying the correlation of different health data evolution and the frailty trajectory of the subject.

Official Title
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Combinatorial Approach of Connected Functions for Multimodal Health Data Collection

Conditions
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Aging, Frailty

Intervention / Treatment
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* Device: Health monitors


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 80 years old Living at home or in senior residence Evaluated as being robust according to the Fried's frailty test (0 met criteria) Affiliated or beneficiary of a social protection scheme Having given written consent Exclusion Criteria: Hospitalization during the month preceding the first visit Subject suffering from cognitive disorders preventing proper use of the device Subject being unable to give by himself / herself his / her consent to participate in the trial Person subject to legal protection (safeguard of justice, trusteeship, guardianship, persons deprived of liberty)

Ages Eligible for Study
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Minimum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Health monitoring<br>Subjects have to monitor their health autonomously using the monitoring platform (connected health devices and app on the touchpad). | Device: Health monitors<br>* The connected scale (iHealth HS2) measures weight from 5 to 180kg and BMI. The connected actimeter (iHealth AM4) monitors activity (number of steps, distance, calories), sleep (automatic sleep recognition, effective sleep time, number of awakenings) and swimming (automatic activity recognition, session duration, swim type recognition and number of laps). The connected blood pressure monitor (iHealth Track KN-550BT)is a medical device that measures blood pressure and pulse rate. The activity monitor (manufactured by RF Track) consists of a housing that can be positioned as a pendant or at the hip. It includes an accelerometer, gyroscope, magnetometer, barometer, radio transceiver, and led. The sensor records the raw signals. The touchpad allows the subject to connect to the Calliope app. This app allows the data recovery, storage, analysis, visualization, and all the required settings for the platform to work together.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Beliefs modified questionnaire | questionnaire by Fishbein & Ajzen (1975), is a qualitative questionnaire, with no scoring | 1 month | 
| UTAUT modified questionnaire | questionnaire by Venkatesh et al. (2003) Final score is graded 1 to 10, 10 being the best score | 1 month | 
| Usability SUS questionnaire | questionnaire by Brooks (1996) Final score is graded 10 to 70, 70 being the best score | 1 month | 
| Comfort modified questionnaire | questionnaire by Knight & Baber (2005) Final score is graded 11 to 77, 77 being the best score | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Motivation modified questionnaire | questionnaire by Deci & Ryan (1987), is a qualitative questionnaire, with no scoring | inclusion | 
| Beliefs modified questionnaire | questionnaire by Fishbein & Ajzen (1975), is a qualitative questionnaire, with no scoring | inclusion | 
| Beliefs modified questionnaire | a priori acceptability questionnaire by Fishbein & Ajzen (1975), is a qualitative questionnaire, with no scoring | 12 months | 
| Beliefs modified questionnaire | a priori acceptability questionnaire by Fishbein & Ajzen (1975), is a qualitative questionnaire, with no scoring | 24 months | 
| UTAUT modified questionnaire | questionnaire by Venkatesh et al. (2003) Final score is graded 1 to 10, 10 being the best score | inclusion | 
| UTAUT modified questionnaire | questionnaire by Venkatesh et al. (2003) Final score is graded 1 to 10, 10 being the best score | 12 months | 
| UTAUT modified questionnaire | questionnaire by Venkatesh et al. (2003) Final score is graded 1 to 10, 10 being the best score | 24 months | 
| Comfort modified questionnaire | questionnaire by Knight & Baber (2005) Final score is graded 11 to 77, 77 being the best score | inclusion | 
| Comfort modified questionnaire | questionnaire by Knight & Baber (2005) Final score is graded 11 to 77, 77 being the best score | 12 months | 
| Comfort modified questionnaire | questionnaire by Knight & Baber (2005) Final score is graded 11 to 77, 77 being the best score | 24 months | 
| Usability SUS questionnaire | questionnaire by Brooks (1996) Final score is graded 10 to 70, 70 being the best score | inclusion | 
| Usability SUS questionnaire | questionnaire by Brooks (1996) Final score is graded 10 to 70, 70 being the best score | 12 months | 
| Usability SUS questionnaire | questionnaire by Brooks (1996) Final score is graded 10 to 70, 70 being the best score | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Health monitoring, Frailty, Home care, Home support