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Gerontological Telemonitoring of Older Adults Living in Nursing Homes With COVID-19 Disease (COVIDeHPAD)

Primary Purpose

Coronavirus Infection

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
telehealth applications
Sponsored by
University Hospital, Limoges
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Coronavirus Infection focused on measuring Covid-19, early gerontologic healthcare

Eligibility Criteria

75 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Nursing home resident with Covid disease RT-PCR or Chest CT or rapid test
  • Nursing home resident with Covid-19 disease symptoms :
  • fever
  • cough
  • dyspnea
  • SPO2<95% in ambient air (or <91% in COPD patient)
  • Diarrhea
  • Fall or balance disorder
  • Confusion

Exclusion Criteria:

  • Age < 75 years
  • Patient in respiratory distress
  • No consent

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    gerontological telemonitoring action

    routine care without gerontological telemonitoring

    Arm Description

    Nurses answer a daily resident-reported questionnaire (e.g. temperature, dyspnea, pain), edited by French health authorities. From D0 to D20, data are transmitted to the NHSP. Warning algorithms specially developed for older persons identify signs that are monitored by the NHSP geriatrician coordinator. A feedback is provided to the general physician for specific actions required and appropriate support. A last questionnaire is completed at D30 by the nurse in order to stop monitoring and know event occurred between D20 to D30.

    routine care

    Outcomes

    Primary Outcome Measures

    Impact of Gerontological telemonitoring on healthcare management for older adults living in Nursing Homes with symptoms of confirmed or probable COVID-19 disease (Death within 30 days).

    Secondary Outcome Measures

    Full Information

    First Posted
    April 3, 2020
    Last Updated
    May 29, 2020
    Sponsor
    University Hospital, Limoges
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04337788
    Brief Title
    Gerontological Telemonitoring of Older Adults Living in Nursing Homes With COVID-19 Disease
    Acronym
    COVIDeHPAD
    Official Title
    Gerontological Telemonitoring of Older Adults Living in Nursing Homes With Symptoms of Confirmed or Probable COVID-19 Disease
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    May 2020 (Anticipated)
    Primary Completion Date
    July 2020 (Anticipated)
    Study Completion Date
    September 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University Hospital, Limoges

    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
    Since the last 3 months the world copes with the novel coronavirus disease : Covid-19 emerged in China in the end of 2019. WHO declared the pandemic situation as a Public Health Emergency around the world on January 2020. Firsts studies emphasized on higher risk to older adults to experience serious health consequences : hospitalizations and mortality, due to multimorbidity and multimedication. Nursing home resident are particulary frailer and vulnerable.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Coronavirus Infection
    Keywords
    Covid-19, early gerontologic healthcare

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Prospective cohort study (here and elsewhere)
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    200 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    gerontological telemonitoring action
    Arm Type
    Experimental
    Arm Description
    Nurses answer a daily resident-reported questionnaire (e.g. temperature, dyspnea, pain), edited by French health authorities. From D0 to D20, data are transmitted to the NHSP. Warning algorithms specially developed for older persons identify signs that are monitored by the NHSP geriatrician coordinator. A feedback is provided to the general physician for specific actions required and appropriate support. A last questionnaire is completed at D30 by the nurse in order to stop monitoring and know event occurred between D20 to D30.
    Arm Title
    routine care without gerontological telemonitoring
    Arm Type
    No Intervention
    Arm Description
    routine care
    Intervention Type
    Other
    Intervention Name(s)
    telehealth applications
    Intervention Description
    telehealth applications during 30 days/patient
    Primary Outcome Measure Information:
    Title
    Impact of Gerontological telemonitoring on healthcare management for older adults living in Nursing Homes with symptoms of confirmed or probable COVID-19 disease (Death within 30 days).
    Time Frame
    day 30

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Nursing home resident with Covid disease RT-PCR or Chest CT or rapid test Nursing home resident with Covid-19 disease symptoms : fever cough dyspnea SPO2<95% in ambient air (or <91% in COPD patient) Diarrhea Fall or balance disorder Confusion Exclusion Criteria: Age < 75 years Patient in respiratory distress No consent
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Achille TCHALLA, MD
    Phone
    +33 5 55 05 86 26
    Email
    achille.tchalla@chu-limoges.fr

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Gerontological Telemonitoring of Older Adults Living in Nursing Homes With COVID-19 Disease

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