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

Combinatorial Approach of Connected Functions for Multimodal Health Data Collection

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Frailty; Aging
• Intervention / Treatment: Device: Health monitors

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dominique SOMME, MD, PhD; Phone Number: 0033299286905; Email: dominique.somme@chu-rennes.fr
• Study Contact Backup: Name: Fabien LEMOINE; Email: fabien.lemoine@univ-rennes1.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 80 years and older (OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: Health monitoring; Subjects have to monitor their health autonomously using the monitoring platform (connected health devices and app on the touchpad).

Device: Health monitors; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Rennes University Hospital
• Collaborators: AZNetwork; RF-Track; LTSI Rennes
• Investigators: Principal Investigator: Dominique SOMME, MD, PhD, Rennes University Hospital

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): September 1, 2020
• Primary Completion (ANTICIPATED): September 1, 2023
• Study Completion (ANTICIPATED): March 1, 2024

Study Registration Dates

• First Submitted: August 12, 2020
• First Submitted That Met QC Criteria: August 12, 2020
• First Posted (ACTUAL): August 17, 2020

Study Record Updates

• Last Update Posted (ACTUAL): August 19, 2020
• Last Update Submitted That Met QC Criteria: August 17, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: Frailty; Home care; Health monitoring; Home support
• Additional Relevant MeSH Terms: Pathologic Processes; Frailty
• Other Study ID Numbers: 2019-A02316-51

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No