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Impact on Family or Care-givers of Very Old ICU-survivors, Trajectories and 6 Months' Outcome in the Very Old. (VIP2)

Primary Purpose

Functionally-Impaired Elderly, Caregivers, PTSD

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Telephone support on demand
Sponsored by
University of Bergen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Functionally-Impaired Elderly

Eligibility Criteria

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

Inclusion Criteria:

  • Hospital survivors after any ICU admission

Exclusion Criteria:

  • Imminent terminal care

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Active Comparator

    Arm Label

    Usual care

    Telephone support

    Arm Description

    ICU with ordinary care for elderly ICU survivors and their care-givers

    ICU with day-time telephone support to care-givers

    Outcomes

    Primary Outcome Measures

    Burden scale for Family Caregiver
    In order to assess the burden of care the investigaors will use an European questionaire developed within the EU and freely available online: Assessment of subjective burden of informal caregivers (http://www.psychiatrie.uk-erlangen.de/index.php?id=11049/) available in 20 European languages
    Post traumatic stress (PTSD) in caregivers
    The study will use PTSD questionnaire PTSS-14 as described at www.sthk.nhs.uk/library/documents/7308450_ptss14.pdf.
    Anxiety and Depression in caregivers
    The investigators will use the "Hospital anxiety and depression scale", a questionaire often used out of hospital as well. It is a simple questionaire that will be delivered to the care-givers after 6 months.

    Secondary Outcome Measures

    6 months survival in the elderly ICU survivors
    Time of death in non-survivors (patients) will be sought through administrative hospital data (when available) or from care-givers
    Trajectories in the elderly ICU survivors
    The investigators will seek to describe where the patients have been after hospital discharge: like rehabilitation facilities, nursing home, togehter with care-givers or in their own home.

    Full Information

    First Posted
    April 26, 2017
    Last Updated
    April 27, 2021
    Sponsor
    University of Bergen
    Collaborators
    European Society of Intensive Care Medicine
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03138278
    Brief Title
    Impact on Family or Care-givers of Very Old ICU-survivors, Trajectories and 6 Months' Outcome in the Very Old.
    Acronym
    VIP2
    Official Title
    Impact on Family or Care-givers of Very Old ICU-survivors, Trajectories and 6 Months' Outcome in the Very Old.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    December 2021 (Anticipated)
    Primary Completion Date
    May 2022 (Anticipated)
    Study Completion Date
    May 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Bergen
    Collaborators
    European Society of Intensive Care Medicine

    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
    It is known from extensive documentation that second victims in critical illness often are the care givers of the patients: family, friends or other persons. Although this has not been specifically studied in the very old patients, there is no reason to believe that this group will be different from other ICU patients. Even more so, in this very old age patient group there are seldom any older relatives. Partners, like wife/husband or other cohabitants, may be dead or themselves incapacitated. Many will be in institutional care. The closest care-givers will be middle-aged people such as children or others, if no partners are available. The hypothesis is that critical illness can be a large stressor to care-givers of survivors in the VIP measured as the occurrence and severity of the usual problems like PTSD and depression. The investigators hypothesize that a low-threshold on-line support program decreases the magnitude of anxiety, depression and PTSD for care-givers of very old intensive care patients (VIP) after discharge.
    Detailed Description
    Aims of the study Results from family/care givers experience: Degree of involvement with post-ICU care, impact on their own health (depression, PTSD, burden questionnaire) Effect of a simple intervention: on-line support and/or telephone advice on Return to pre-ICU frailty score (patients) and Occurrence of PTSD and depression in care-givers Information on 6 months' outcome (frailty and mortality) in very old survivors after ICU in different European countries Information on trajectories in the time after discharge: Dead/alive, home, nursing home, new hospital admissions, living with family/other care-givers, etc.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Functionally-Impaired Elderly, Caregivers, PTSD, Depression, Anxiety, Intensive Care Unit Syndrome

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Multicentre study with ≥ 100 ICUs from Europe. Randomisation at ICU level to give support to caregivers or not (cluster-randomisation)
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    1000 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Usual care
    Arm Type
    No Intervention
    Arm Description
    ICU with ordinary care for elderly ICU survivors and their care-givers
    Arm Title
    Telephone support
    Arm Type
    Active Comparator
    Arm Description
    ICU with day-time telephone support to care-givers
    Intervention Type
    Other
    Intervention Name(s)
    Telephone support on demand
    Intervention Description
    Dedicated phone number for help and advice for caregivers
    Primary Outcome Measure Information:
    Title
    Burden scale for Family Caregiver
    Description
    In order to assess the burden of care the investigaors will use an European questionaire developed within the EU and freely available online: Assessment of subjective burden of informal caregivers (http://www.psychiatrie.uk-erlangen.de/index.php?id=11049/) available in 20 European languages
    Time Frame
    6 months post ICU discharge
    Title
    Post traumatic stress (PTSD) in caregivers
    Description
    The study will use PTSD questionnaire PTSS-14 as described at www.sthk.nhs.uk/library/documents/7308450_ptss14.pdf.
    Time Frame
    6 months post ICU discharge
    Title
    Anxiety and Depression in caregivers
    Description
    The investigators will use the "Hospital anxiety and depression scale", a questionaire often used out of hospital as well. It is a simple questionaire that will be delivered to the care-givers after 6 months.
    Time Frame
    6 months post ICU discharge
    Secondary Outcome Measure Information:
    Title
    6 months survival in the elderly ICU survivors
    Description
    Time of death in non-survivors (patients) will be sought through administrative hospital data (when available) or from care-givers
    Time Frame
    6 months post ICU discharge
    Title
    Trajectories in the elderly ICU survivors
    Description
    The investigators will seek to describe where the patients have been after hospital discharge: like rehabilitation facilities, nursing home, togehter with care-givers or in their own home.
    Time Frame
    6 months post ICU discharge

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Hospital survivors after any ICU admission Exclusion Criteria: Imminent terminal care
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Hans Flaatten, Prof
    Phone
    +4755972450
    Email
    hans.flaatten@uib.no
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Hans Flaatten, Prof
    Organizational Affiliation
    University of bergen; ESICM
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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