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Telemedicine - Evaluation of the Impact of a Telemedicine Device (DTM) on the Prevention of Emergency Department Visits and Hospitalizations of Nursing Home Residents Aged Polypathological (GERONTACCESS)

Primary Purpose

Polypathology

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Telemedecine
Sponsored by
University Hospital, Limoges
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Polypathology focused on measuring Telemedecine

Eligibility Criteria

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

Inclusion Criteria:

  • Resident in one of 9 nursing homes participating in the project
  • Resident polypathologique has at least two comorbidities
  • Having made no request to change place of residence at the time of the inclusion visit
  • Having given free consent, informed writing and signed by himself and / or his legal representative

Exclusion Criteria:

  • Unaffiliated resident or non-receiving of social security
  • severe pathology (ies) involving life-threatening in the short term
  • Resident whose return home, transfer to another nursing home or to a long term care unit is programmed

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Telemedecine

    Control

    Arm Description

    Patients benefiting from telemedicine

    routine care without telemedecine

    Outcomes

    Primary Outcome Measures

    Evaluation of telemedicine on prevention in old and polypathological patients
    Proportion of patients with emergency admission or unscheduled hospitalization in medical or surgical service over 12 months.

    Secondary Outcome Measures

    Medico-economic impact
    cost effectiveness of the telemedicine device
    Impact on recurring hospitalizations
    Number of readmissions
    Impact on overall health
    Number of emergency admissions Number of readmissions Number of days of hospitalization Number of medical consultations o
    Impact on the quality of life ( EQ5D questionnary)
    The EQ-5D (Europen Qyuality of llive) five dimension scale) questionnaire has two components: health state description and evaluation. In the description part, health status is measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Mobility dimension asks about the person's walking ability. Self-care dimension asks about the ability to wash or dress by oneself, and usual activities dimension measures performance in "work, study, housework, family or leisure activities". In pain/discomfort dimension, it asks how much pain or discomfort they have, and in anxiety/depression dimension, it asks how anxious or depressed they are. Higher values represent a worse outcome. The scale ranges from 5 to 15.
    Impact on mortality
    Proportion of patients who died at 12 months

    Full Information

    First Posted
    July 2, 2019
    Last Updated
    August 8, 2019
    Sponsor
    University Hospital, Limoges
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04008472
    Brief Title
    Telemedicine - Evaluation of the Impact of a Telemedicine Device (DTM) on the Prevention of Emergency Department Visits and Hospitalizations of Nursing Home Residents Aged Polypathological
    Acronym
    GERONTACCESS
    Official Title
    Telemedicine - Evaluation of the Impact of a Telemedicine Device (DTM) on the Prevention of Emergency Department Visits and Hospitalizations of Nursing Home Residents Aged Polypathological
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2015 (Actual)
    Primary Completion Date
    January 2018 (Actual)
    Study Completion Date
    May 2019 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    For several decades, there is an aging population, particularly in industrialized countries. This lengthening of the duration of life is accompanied by an increase in the number of chronically ill patients. On an estimate of 15 million patients in France today, the figure reported for 2020 would be 20 million patients. Chronic diseases are responsible for functional decompensation and admission responsible autonomy breaks in nursing homes (Accommodation Establishment of People Dependent Elderly). An estimated 700,000 the number of people currently living in retirement homes in France. These residents are mostly dependent and multiple pathologies requiring regular general and specialist medical monitoring . Medical concern demographic outlook and the need for access to quality care across the country leads to the development of telemedicine. The need for telemedicine is not the same throughout the territory. It is less, or different, in highly urbanized areas where the density of health professionals is high, then it can be a new response to the needs of rural, isolated or landlocked. Telemedicine promotes the development of the concept of graduated care sector, especially in the management of patients with chronic diseases. Telemedicine in rural nursing homes and can be a tool for assessing, monitoring and coordination to avoid decompensation of chronic conditions and rehospitalization. This organization can afford to break the isolation of general practitioners and EHPAD coordinators physicians in rural areas and provide access to several specialties.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Polypathology
    Keywords
    Telemedecine

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    428 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Telemedecine
    Arm Type
    Experimental
    Arm Description
    Patients benefiting from telemedicine
    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    routine care without telemedecine
    Intervention Type
    Other
    Intervention Name(s)
    Telemedecine
    Intervention Description
    Initiation of tele-medical consultation with the resident, a caregiver for the nursing home, the referring physician and geriatrician téléexpert. After a overall geriatric assessment in nursing homes by UPSAV the first teleconsultation is organized within 10 days. Subsequent visits are scheduled every 3 months for 12 months. Spontaneous visits can be requested at the initiative of the referring physician.
    Primary Outcome Measure Information:
    Title
    Evaluation of telemedicine on prevention in old and polypathological patients
    Description
    Proportion of patients with emergency admission or unscheduled hospitalization in medical or surgical service over 12 months.
    Time Frame
    After 12 months
    Secondary Outcome Measure Information:
    Title
    Medico-economic impact
    Description
    cost effectiveness of the telemedicine device
    Time Frame
    After 12 months
    Title
    Impact on recurring hospitalizations
    Description
    Number of readmissions
    Time Frame
    After 12 months
    Title
    Impact on overall health
    Description
    Number of emergency admissions Number of readmissions Number of days of hospitalization Number of medical consultations o
    Time Frame
    After 12 months
    Title
    Impact on the quality of life ( EQ5D questionnary)
    Description
    The EQ-5D (Europen Qyuality of llive) five dimension scale) questionnaire has two components: health state description and evaluation. In the description part, health status is measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Mobility dimension asks about the person's walking ability. Self-care dimension asks about the ability to wash or dress by oneself, and usual activities dimension measures performance in "work, study, housework, family or leisure activities". In pain/discomfort dimension, it asks how much pain or discomfort they have, and in anxiety/depression dimension, it asks how anxious or depressed they are. Higher values represent a worse outcome. The scale ranges from 5 to 15.
    Time Frame
    After 12 months
    Title
    Impact on mortality
    Description
    Proportion of patients who died at 12 months
    Time Frame
    After 12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Resident in one of 9 nursing homes participating in the project Resident polypathologique has at least two comorbidities Having made no request to change place of residence at the time of the inclusion visit Having given free consent, informed writing and signed by himself and / or his legal representative Exclusion Criteria: Unaffiliated resident or non-receiving of social security severe pathology (ies) involving life-threatening in the short term Resident whose return home, transfer to another nursing home or to a long term care unit is programmed
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Achille TCHALLA, Professor
    Organizational Affiliation
    University Hospital, Limoges
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Telemedicine - Evaluation of the Impact of a Telemedicine Device (DTM) on the Prevention of Emergency Department Visits and Hospitalizations of Nursing Home Residents Aged Polypathological

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