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

Primary Purpose

Aging, Frailty

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Health monitors
Sponsored by
Rennes University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Aging focused on measuring Health monitoring, Frailty, Home care, Home support

Eligibility Criteria

80 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Health monitoring

    Arm Description

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

    Outcomes

    Primary Outcome Measures

    Beliefs modified questionnaire
    questionnaire by Fishbein & Ajzen (1975), is a qualitative questionnaire, with no scoring
    UTAUT modified questionnaire
    questionnaire by Venkatesh et al. (2003) Final score is graded 1 to 10, 10 being the best score
    Usability SUS questionnaire
    questionnaire by Brooks (1996) Final score is graded 10 to 70, 70 being the best score
    Comfort modified questionnaire
    questionnaire by Knight & Baber (2005) Final score is graded 11 to 77, 77 being the best score

    Secondary Outcome Measures

    Motivation modified questionnaire
    questionnaire by Deci & Ryan (1987), is a qualitative questionnaire, with no scoring
    Beliefs modified questionnaire
    questionnaire by Fishbein & Ajzen (1975), is a qualitative questionnaire, with no scoring
    Beliefs modified questionnaire
    a priori acceptability questionnaire by Fishbein & Ajzen (1975), is a qualitative questionnaire, with no scoring
    Beliefs modified questionnaire
    a priori acceptability questionnaire by Fishbein & Ajzen (1975), is a qualitative questionnaire, with no scoring
    UTAUT modified questionnaire
    questionnaire by Venkatesh et al. (2003) Final score is graded 1 to 10, 10 being the best score
    UTAUT modified questionnaire
    questionnaire by Venkatesh et al. (2003) Final score is graded 1 to 10, 10 being the best score
    UTAUT modified questionnaire
    questionnaire by Venkatesh et al. (2003) Final score is graded 1 to 10, 10 being the best score
    Comfort modified questionnaire
    questionnaire by Knight & Baber (2005) Final score is graded 11 to 77, 77 being the best score
    Comfort modified questionnaire
    questionnaire by Knight & Baber (2005) Final score is graded 11 to 77, 77 being the best score
    Comfort modified questionnaire
    questionnaire by Knight & Baber (2005) Final score is graded 11 to 77, 77 being the best score
    Usability SUS questionnaire
    questionnaire by Brooks (1996) Final score is graded 10 to 70, 70 being the best score
    Usability SUS questionnaire
    questionnaire by Brooks (1996) Final score is graded 10 to 70, 70 being the best score
    Usability SUS questionnaire
    questionnaire by Brooks (1996) Final score is graded 10 to 70, 70 being the best score

    Full Information

    First Posted
    August 12, 2020
    Last Updated
    August 17, 2020
    Sponsor
    Rennes University Hospital
    Collaborators
    AZNetwork, RF-Track, LTSI Rennes
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04514536
    Brief Title
    Evaluation of a Health Monitoring Platform for Elderly in Home Care Context
    Acronym
    ACCORDS
    Official Title
    Combinatorial Approach of Connected Functions for Multimodal Health Data Collection
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2020
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 2020 (Anticipated)
    Primary Completion Date
    September 2023 (Anticipated)
    Study Completion Date
    March 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Rennes University Hospital
    Collaborators
    AZNetwork, RF-Track, LTSI Rennes

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Aging, Frailty
    Keywords
    Health monitoring, Frailty, Home care, Home support

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Health monitoring
    Arm Type
    Experimental
    Arm Description
    Subjects have to monitor their health autonomously using the monitoring platform (connected health devices and app on the touchpad).
    Intervention Type
    Device
    Intervention Name(s)
    Health monitors
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Beliefs modified questionnaire
    Description
    questionnaire by Fishbein & Ajzen (1975), is a qualitative questionnaire, with no scoring
    Time Frame
    1 month
    Title
    UTAUT modified questionnaire
    Description
    questionnaire by Venkatesh et al. (2003) Final score is graded 1 to 10, 10 being the best score
    Time Frame
    1 month
    Title
    Usability SUS questionnaire
    Description
    questionnaire by Brooks (1996) Final score is graded 10 to 70, 70 being the best score
    Time Frame
    1 month
    Title
    Comfort modified questionnaire
    Description
    questionnaire by Knight & Baber (2005) Final score is graded 11 to 77, 77 being the best score
    Time Frame
    1 month
    Secondary Outcome Measure Information:
    Title
    Motivation modified questionnaire
    Description
    questionnaire by Deci & Ryan (1987), is a qualitative questionnaire, with no scoring
    Time Frame
    inclusion
    Title
    Beliefs modified questionnaire
    Description
    questionnaire by Fishbein & Ajzen (1975), is a qualitative questionnaire, with no scoring
    Time Frame
    inclusion
    Title
    Beliefs modified questionnaire
    Description
    a priori acceptability questionnaire by Fishbein & Ajzen (1975), is a qualitative questionnaire, with no scoring
    Time Frame
    12 months
    Title
    Beliefs modified questionnaire
    Description
    a priori acceptability questionnaire by Fishbein & Ajzen (1975), is a qualitative questionnaire, with no scoring
    Time Frame
    24 months
    Title
    UTAUT modified questionnaire
    Description
    questionnaire by Venkatesh et al. (2003) Final score is graded 1 to 10, 10 being the best score
    Time Frame
    inclusion
    Title
    UTAUT modified questionnaire
    Description
    questionnaire by Venkatesh et al. (2003) Final score is graded 1 to 10, 10 being the best score
    Time Frame
    12 months
    Title
    UTAUT modified questionnaire
    Description
    questionnaire by Venkatesh et al. (2003) Final score is graded 1 to 10, 10 being the best score
    Time Frame
    24 months
    Title
    Comfort modified questionnaire
    Description
    questionnaire by Knight & Baber (2005) Final score is graded 11 to 77, 77 being the best score
    Time Frame
    inclusion
    Title
    Comfort modified questionnaire
    Description
    questionnaire by Knight & Baber (2005) Final score is graded 11 to 77, 77 being the best score
    Time Frame
    12 months
    Title
    Comfort modified questionnaire
    Description
    questionnaire by Knight & Baber (2005) Final score is graded 11 to 77, 77 being the best score
    Time Frame
    24 months
    Title
    Usability SUS questionnaire
    Description
    questionnaire by Brooks (1996) Final score is graded 10 to 70, 70 being the best score
    Time Frame
    inclusion
    Title
    Usability SUS questionnaire
    Description
    questionnaire by Brooks (1996) Final score is graded 10 to 70, 70 being the best score
    Time Frame
    12 months
    Title
    Usability SUS questionnaire
    Description
    questionnaire by Brooks (1996) Final score is graded 10 to 70, 70 being the best score
    Time Frame
    24 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility 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)
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Dominique SOMME, MD, PhD
    Phone
    0033299286905
    Email
    dominique.somme@chu-rennes.fr
    First Name & Middle Initial & Last Name or Official Title & Degree
    Fabien LEMOINE
    Email
    fabien.lemoine@univ-rennes1.fr
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Dominique SOMME, MD, PhD
    Organizational Affiliation
    Rennes University Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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

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