NCT04514536

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 12, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 17, 2020

Completed
24 days until next milestone

Study Start

First participant enrolled

September 10, 2020

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 4, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 4, 2023

Completed
Last Updated

June 24, 2026

Status Verified

June 1, 2026

Enrollment Period

2.8 years

First QC Date

August 12, 2020

Last Update Submit

June 23, 2026

Conditions

AgingFrailty

Keywords

Health monitoringFrailtyHome careHome support

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (13)

  • Motivation modified questionnaire

    inclusion

  • Beliefs modified questionnaire

    inclusion

  • Beliefs modified questionnaire

    12 months

  • Beliefs modified questionnaire

    24 months

  • UTAUT modified questionnaire

    inclusion

  • +8 more secondary outcomes

Study Arms (1)

Health monitoring

EXPERIMENTAL

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

Device: Health monitors

Interventions

Health monitorsDEVICE

* 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.

Health monitoring

Eligibility Criteria

Age80 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu Rennes

Rennes, France, 35000, France

Location

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Dominique SOMME, MD, PhD

    Rennes University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 12, 2020

First Posted

August 17, 2020

Study Start

September 10, 2020

Primary Completion

July 4, 2023

Study Completion

July 4, 2023

Last Updated

June 24, 2026

Record last verified: 2026-06

Locations

FR(1)