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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)

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ClinicalTrials.gov Identifier: NCT03138278
Recruitment Status : Not yet recruiting
First Posted : May 3, 2017
Last Update Posted : May 3, 2017
Sponsor:
Collaborator:
European Society of Intensive Care Medicine
Information provided by (Responsible Party):
Hans Flaatten, University of Bergen

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.


Condition or disease Intervention/treatment Phase
Functionally-Impaired Elderly Caregivers PTSD Depression, Anxiety Intensive Care Unit Syndrome Other: Telephone support on demand Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Supportive Care
Official Title: Impact on Family or Care-givers of Very Old ICU-survivors, Trajectories and 6 Months' Outcome in the Very Old.
Estimated Study Start Date : December 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : May 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety Caregivers

Arm Intervention/treatment
No Intervention: Usual care
ICU with ordinary care for elderly ICU survivors and their care-givers
Active Comparator: Telephone support
ICU with day-time telephone support to care-givers
Other: Telephone support on demand
Dedicated phone number for help and advice for caregivers




Primary Outcome Measures :
  1. Burden scale for Family Caregiver [ Time Frame: 6 months post ICU discharge ]
    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

  2. Post traumatic stress (PTSD) in caregivers [ Time Frame: 6 months post ICU discharge ]
    The study will use PTSD questionnaire PTSS-14 as described at www.sthk.nhs.uk/library/documents/7308450_ptss14.pdf.

  3. Anxiety and Depression in caregivers [ Time Frame: 6 months post ICU discharge ]
    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 :
  1. 6 months survival in the elderly ICU survivors [ Time Frame: 6 months post ICU discharge ]
    Time of death in non-survivors (patients) will be sought through administrative hospital data (when available) or from care-givers

  2. Trajectories in the elderly ICU survivors [ Time Frame: 6 months post ICU discharge ]
    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.



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:   No
Criteria

Inclusion Criteria:

  • Hospital survivors after any ICU admission

Exclusion Criteria:

  • Imminent terminal care

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): NCT03138278


Contacts
Contact: Hans Flaatten, Prof +4755972450 hans.flaatten@uib.no

Sponsors and Collaborators
University of Bergen
European Society of Intensive Care Medicine
Investigators
Principal Investigator: Hans Flaatten, Prof University of bergen; ESICM

Responsible Party: Hans Flaatten, Professor and senior ICU consultant, University of Bergen
ClinicalTrials.gov Identifier: NCT03138278     History of Changes
Other Study ID Numbers: ESICM VIP2
First Posted: May 3, 2017    Key Record Dates
Last Update Posted: May 3, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No