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

Aging Clinical Trial

— ACCORDS  

Official title:

Combinatorial Approach of Connected Functions for Multimodal Health Data Collection

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04514536
• Other study ID #: 2019-A02316-51
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2020
• Est. completion date: March 2024

Study information

• Verified date: August 2020
• Source: Rennes University Hospital
• Contact: Dominique SOMME, MD, PhD
• Phone: 0033299286905
• Email: dominique.somme[@]chu-rennes.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: March 2024
• Est. primary completion date: September 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 80 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Aging
• Frailty

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
Rennes University Hospital	AZNetwork, LTSI Rennes, RF-Track

Outcome

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