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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04514536
Recruitment Status : Not yet recruiting
First Posted : August 17, 2020
Last Update Posted : August 19, 2020
Sponsor:
Collaborators:
AZNetwork
RF-Track
LTSI Rennes
Information provided by (Responsible Party):
Rennes University Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Aging Frailty Device: Health monitors Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Combinatorial Approach of Connected Functions for Multimodal Health Data Collection
Estimated Study Start Date : September 2020
Estimated Primary Completion Date : September 2023
Estimated Study Completion Date : March 2024
Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Beliefs modified questionnaire [ Time Frame: 1 month ]
    questionnaire by Fishbein & Ajzen (1975), is a qualitative questionnaire, with no scoring

  2. UTAUT modified questionnaire [ Time Frame: 1 month ]
    questionnaire by Venkatesh et al. (2003) Final score is graded 1 to 10, 10 being the best score

  3. Usability SUS questionnaire [ Time Frame: 1 month ]
    questionnaire by Brooks (1996) Final score is graded 10 to 70, 70 being the best score

  4. Comfort modified questionnaire [ Time Frame: 1 month ]
    questionnaire by Knight & Baber (2005) Final score is graded 11 to 77, 77 being the best score


Secondary Outcome Measures :
  1. Motivation modified questionnaire [ Time Frame: inclusion ]
    questionnaire by Deci & Ryan (1987), is a qualitative questionnaire, with no scoring

  2. Beliefs modified questionnaire [ Time Frame: inclusion ]
    questionnaire by Fishbein & Ajzen (1975), is a qualitative questionnaire, with no scoring

  3. Beliefs modified questionnaire [ Time Frame: 12 months ]
    a priori acceptability questionnaire by Fishbein & Ajzen (1975), is a qualitative questionnaire, with no scoring

  4. Beliefs modified questionnaire [ Time Frame: 24 months ]
    a priori acceptability questionnaire by Fishbein & Ajzen (1975), is a qualitative questionnaire, with no scoring

  5. UTAUT modified questionnaire [ Time Frame: inclusion ]
    questionnaire by Venkatesh et al. (2003) Final score is graded 1 to 10, 10 being the best score

  6. UTAUT modified questionnaire [ Time Frame: 12 months ]
    questionnaire by Venkatesh et al. (2003) Final score is graded 1 to 10, 10 being the best score

  7. UTAUT modified questionnaire [ Time Frame: 24 months ]
    questionnaire by Venkatesh et al. (2003) Final score is graded 1 to 10, 10 being the best score

  8. Comfort modified questionnaire [ Time Frame: inclusion ]
    questionnaire by Knight & Baber (2005) Final score is graded 11 to 77, 77 being the best score

  9. Comfort modified questionnaire [ Time Frame: 12 months ]
    questionnaire by Knight & Baber (2005) Final score is graded 11 to 77, 77 being the best score

  10. Comfort modified questionnaire [ Time Frame: 24 months ]
    questionnaire by Knight & Baber (2005) Final score is graded 11 to 77, 77 being the best score

  11. Usability SUS questionnaire [ Time Frame: inclusion ]
    questionnaire by Brooks (1996) Final score is graded 10 to 70, 70 being the best score

  12. Usability SUS questionnaire [ Time Frame: 12 months ]
    questionnaire by Brooks (1996) Final score is graded 10 to 70, 70 being the best score

  13. Usability SUS questionnaire [ Time Frame: 24 months ]
    questionnaire by Brooks (1996) Final score is graded 10 to 70, 70 being the best score


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   80 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04514536


Contacts
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Contact: Dominique SOMME, MD, PhD 0033299286905 dominique.somme@chu-rennes.fr
Contact: Fabien LEMOINE fabien.lemoine@univ-rennes1.fr

Sponsors and Collaborators
Rennes University Hospital
AZNetwork
RF-Track
LTSI Rennes
Investigators
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Principal Investigator: Dominique SOMME, MD, PhD Rennes University Hospital
More Information
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Responsible Party: Rennes University Hospital
ClinicalTrials.gov Identifier: NCT04514536    
Other Study ID Numbers: 2019-A02316-51
First Posted: August 17, 2020    Key Record Dates
Last Update Posted: August 19, 2020
Last Verified: August 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rennes University Hospital:
Health monitoring
Frailty
Home care
Home support
Additional relevant MeSH terms:
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Frailty
Pathologic Processes