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

NCT ID: NCT04514536

Last Updated: 2020-08-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-30

Study Completion Date

2024-03-31

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.

Detailed Description

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Conditions

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Aging Frailty

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Health monitoring

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

Group Type EXPERIMENTAL

Health monitors

Intervention Type DEVICE

* 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.

Interventions

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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.

Intervention Type DEVICE

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)
Minimum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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AZNetwork

UNKNOWN

Sponsor Role collaborator

RF-Track

UNKNOWN

Sponsor Role collaborator

LTSI Rennes

UNKNOWN

Sponsor Role collaborator

Rennes University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dominique SOMME, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Rennes University Hospital

Central Contacts

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Dominique SOMME, MD, PhD

Role: CONTACT

0033299286905

Fabien LEMOINE

Role: CONTACT

Other Identifiers

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2019-A02316-51

Identifier Type: -

Identifier Source: org_study_id

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