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
About this trial
This is an interventional supportive care trial for Functionally-Impaired Elderly
Eligibility Criteria
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
NCT ID
NCT03138278
First Posted
April 26, 2017
Last Updated
April 27, 2021
Sponsor
University of Bergen
Collaborators
European Society of Intensive Care Medicine
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
Impact on Family or Care-givers of Very Old ICU-survivors, Trajectories and 6 Months' Outcome in the Very Old.
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